Infertility
Conditions
Brief summary
Prospective open label, randomised, parallel group, comparative pilot.
Detailed description
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.
Interventions
DRUGMenotrophin
150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
DRUGFollitropin alfa
150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Female patients aged \> or = 20 and \< or = 35 years with a BMI of \>18 and \<32 kg/m2 who have received no more than two previous cycles of in vitro fertilisation (IVF) or other assisted reproductive technique (ART) and whose partners have normal sperm (according to WHO 1999 criteria). Inclusion criteria: * Signed informed consent; * Subfertile premenopausal female patients eligible for IVF treatment; * Aged \>=20 and \<=35 years; * Body mass index of \>18 and \<32 kg/m2 * Normal endocrine assessment within the last 6 months; * Normal pelvic ultrasound (showing two ovaries, no ovarian abnormalities and normal uterus) within the last 6 months; * Receipt of no more than two previous cycles of IVF (or other ART); * At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months; * No fertility-modifying treatment within the 3 months prior to this treatment cycle; * Infertility attributable to or in association with either tubal factor, or unexplained causes; * Sperm of partner classed as normal according to WHO 1999 criteria within the year prior to beginning therapy; * Negative serum beta-HCG pregnancy test prior to beginning therapy; * Clinically normal baseline haematology, clinical chemistry, and urinalysis parameter values, negative serum HBsAg and HIV antibody tests; * Screening endocrine test results (estradiol, LH, FSH, progesterone, prolactin, TSH) in early follicular phase within the normal limits for the clinical laboratory.
Exclusion criteria
* Presence of any clinically relevant systemic disease(e.g. insulin- dependent diabetes mellitus); * A history of or current endocrine disease, including polycystic ovary- like syndrome and hyperprolactinaemia; * A history of coagulation disorders; * Persistent ovarian cysts; * Contraindications for the use of gonadotrophins or GnRH antagonists; * A history of hypersensitivity to any of the constituents of the study medication or related compounds; * Three or more previous cycles of IVF (or other ART); * A history of alcohol abuse (more than 30 units per week on a regular basis); * History of chemo- or radiotherapy; * Currently breast-feeding, pregnant or with a contraindication to pregnancy; * Diagnosed poor responders in prior IVF treatment; * History of severe ovarian hyperstimulation syndrome (OHSS) (4 or 5) in former IVF treatment; * Investigational drug within the 30 days prior to treatment; * Any other condition or history that the investigator considers might increase the risk to the individual.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Ongoing Pregnancy | Approx week 13; 9 weeks or more after the 1st positive pregnancy test | Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test. |
| Percentage of Participants With an Ongoing Pregnancy | Approx week 13; 9 weeks or more after the first positive pregnancy test | Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Varying Numbers of Pronuclear Stage Oocytes | Approximately study day 15 | Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination. |
| Participants With Varying Numbers of Embryos Transferred | Approximately study day 17 | Number of participants with various categories of numbers of embryos transferred. |
| Participants With Varying Numbers of Embryos Frozen | Approximately study day 17 | Number of participants with different categories of number of embryos frozen. |
| Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) | The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met. |
| Pregnancy Outcomes | Approximately 10 months | Long term follow-up to determine the outcome of the pregnancy. |
| Mean Endometrial Thickness | Day 7 or 9 or 11 or 13 | Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction. |
| Mean Estradiol Level | Day 7 or 9 or 11 or 13 | Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction. |
| Mean Number of Days Stimulated With Gonadotrophins | study days 1 - 13 | Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination. |
| Participants With Varying Numbers of Oocytes Retrieved | Approximately study day 15 | Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with \>= 17mm in diameter. |
Countries
Germany, United Kingdom
Participant flow
Pre-assignment details
Ninety (90) participants were screened and 80 participants randomized.
Participants by arm
| Arm | Count |
|---|---|
| Menotrophin Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) | 37 |
| Follitropin Alfa A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)). | 39 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Did not meet hCG criterion | 3 | 0 |
| Overall Study | other reason | 4 | 6 |
| Overall Study | Physician Decision | 6 | 0 |
Baseline characteristics
| Characteristic | Total | Follitropin Alfa | Menotrophin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 39 Participants | 37 Participants |
| Age Continuous | 30.8 years STANDARD_DEVIATION 3.06 | 30.9 years STANDARD_DEVIATION 2.67 | 30.7 years STANDARD_DEVIATION 3.45 |
| Body Mass Index | 23.91 Kilograms/Meters squared STANDARD_DEVIATION 3.687 | 23.81 Kilograms/Meters squared STANDARD_DEVIATION 3.731 | 24.02 Kilograms/Meters squared STANDARD_DEVIATION 3.689 |
| Diastolic Blood Pressure | 74.0 mm Hg STANDARD_DEVIATION 9.37 | 73.8 mm Hg STANDARD_DEVIATION 9.96 | 74.1 mm Hg STANDARD_DEVIATION 8.83 |
| Pulse | 75.1 beats per minute STANDARD_DEVIATION 9.35 | 74.5 beats per minute STANDARD_DEVIATION 9.16 | 75.7 beats per minute STANDARD_DEVIATION 9.63 |
| Sex: Female, Male Female | 76 Participants | 39 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic Blood Pressure | 115.7 mm Hg STANDARD_DEVIATION 13.51 | 116.1 mm Hg STANDARD_DEVIATION 14.55 | 115.3 mm Hg STANDARD_DEVIATION 12.5 |
| Tobacco Use Ex-smoker | 13 participants | 5 participants | 8 participants |
| Tobacco Use Never Smoked | 51 participants | 26 participants | 25 participants |
| Tobacco Use Smoker | 12 participants | 8 participants | 4 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 37 | 21 / 39 |
| serious Total, serious adverse events | 4 / 37 | 9 / 39 |
Outcome results
Primary
Number of Participants With an Ongoing Pregnancy
Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.
Time frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test
Population: All patients treated population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menotrophin | Number of Participants With an Ongoing Pregnancy | 14 participants |
| Follitropin Alfa | Number of Participants With an Ongoing Pregnancy | 13 participants |
Primary
Percentage of Participants With an Ongoing Pregnancy
Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.
Time frame: Approx week 13; 9 weeks or more after the first positive pregnancy test
Population: All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as YES for ongoing pregnancy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menotrophin | Percentage of Participants With an Ongoing Pregnancy | 37.8 percentage of participants |
| Follitropin Alfa | Percentage of Participants With an Ongoing Pregnancy | 33.3 percentage of participants |
95% CI: [-0.17, 0.26]
Secondary
Mean Endometrial Thickness
Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.
Time frame: Day 7 or 9 or 11 or 13
Population: All patients treated population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menotrophin | Mean Endometrial Thickness | 11.7 millimeters | Standard Deviation 2.73 |
| Follitropin Alfa | Mean Endometrial Thickness | 11.0 millimeters | Standard Deviation 2.31 |
Secondary
Mean Estradiol Level
Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.
Time frame: Day 7 or 9 or 11 or 13
Population: All patient treated population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menotrophin | Mean Estradiol Level | 6706.6 picomoles / liter | Standard Deviation 4109.26 |
| Follitropin Alfa | Mean Estradiol Level | 6268.3 picomoles / liter | Standard Deviation 4132.11 |
Secondary
Mean Number of Days Stimulated With Gonadotrophins
Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.
Time frame: study days 1 - 13
Population: All patients treated population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Menotrophin | Mean Number of Days Stimulated With Gonadotrophins | 9.2 days | Standard Deviation 1.71 |
| Follitropin Alfa | Mean Number of Days Stimulated With Gonadotrophins | 8.9 days | Standard Deviation 1.07 |
Secondary
Participants With Varying Numbers of Embryos Frozen
Number of participants with different categories of number of embryos frozen.
Time frame: Approximately study day 17
Population: All patients treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 1 embryo frozen | 1 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 5 embryos frozen | 0 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 3 embryos frozen | 1 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 6-8 embryos frozen | 0 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 2 embryos frozen | 2 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 9 embryos frozen | 0 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 4 embryos frozen | 4 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 10 embryos frozen | 0 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Frozen | 0 embryos frozen | 16 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 10 embryos frozen | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 0 embryos frozen | 22 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 1 embryo frozen | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 2 embryos frozen | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 3 embryos frozen | 4 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 4 embryos frozen | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 5 embryos frozen | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 6-8 embryos frozen | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Frozen | 9 embryos frozen | 1 participants |
Secondary
Participants With Varying Numbers of Embryos Transferred
Number of participants with various categories of numbers of embryos transferred.
Time frame: Approximately study day 17
Population: All patients treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menotrophin | Participants With Varying Numbers of Embryos Transferred | 0 embryos transferred | 0 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Transferred | 1 embryo transferred | 3 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Transferred | 2 embryos transferred | 21 participants |
| Menotrophin | Participants With Varying Numbers of Embryos Transferred | 3 embryos transferred | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Transferred | 3 embryos transferred | 3 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Transferred | 0 embryos transferred | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Transferred | 2 embryos transferred | 28 participants |
| Follitropin Alfa | Participants With Varying Numbers of Embryos Transferred | 1 embryo transferred | 1 participants |
Secondary
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters
The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.
Time frame: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)
Population: All treated patients population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | Did not meet criterion | 10 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 3 follicles ≥ 17 mm in diameter | 11 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 4 follicles ≥ 17 mm in diameter | 7 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 5 follicles ≥ 17 mm in diameter | 2 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 6 follicles ≥ 17 mm in diameter | 4 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 7 follicles ≥ 17 mm in diameter | 0 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 8 follicles ≥ 17 mm in diameter | 1 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 9 follicles ≥ 17 mm in diameter | 0 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 10 follicles ≥ 17 mm in diameter | 1 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 11-14 follicles ≥ 17 mm in diameter | 0 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 15 follicles ≥ 17 mm in diameter | 0 participants |
| Menotrophin | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 16 follicles ≥ 17 mm in diameter | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 15 follicles ≥ 17 mm in diameter | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | Did not meet criterion | 3 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 8 follicles ≥ 17 mm in diameter | 3 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 3 follicles ≥ 17 mm in diameter | 11 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 11-14 follicles ≥ 17 mm in diameter | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 4 follicles ≥ 17 mm in diameter | 10 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 9 follicles ≥ 17 mm in diameter | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 5 follicles ≥ 17 mm in diameter | 10 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 16 follicles ≥ 17 mm in diameter | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 6 follicles ≥ 17 mm in diameter | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 10 follicles ≥ 17 mm in diameter | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | 7 follicles ≥ 17 mm in diameter | 0 participants |
Secondary
Participants With Varying Numbers of Oocytes Retrieved
Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with \>= 17mm in diameter.
Time frame: Approximately study day 15
Population: All treated patients population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 10 oocytes retrieved | 1 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 12 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 6 oocytes retrieved | 4 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 13 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 3 oocytes retrieved | 3 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 14 oocytes retrieved | 1 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 7 oocytes retrieved | 2 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 15 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 1 oocyte retrieved | 1 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 16 oocytes retrieved | 1 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 8 oocytes retrieved | 2 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 17-18 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 4 oocytes retrieved | 2 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 19 oocytes retrieved | 1 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 9 oocytes retrieved | 2 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 20 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 2 oocytes retrieved | 3 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 21 oocytes retrieved | 1 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 5 oocytes retrieved | 2 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 22 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 11 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 23 oocytes retrieved | 0 participants |
| Menotrophin | Participants With Varying Numbers of Oocytes Retrieved | 0 oocytes retrieved | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 23 oocytes retrieved | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 0 oocytes retrieved | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 1 oocyte retrieved | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 2 oocytes retrieved | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 3 oocytes retrieved | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 4 oocytes retrieved | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 5 oocytes retrieved | 5 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 6 oocytes retrieved | 4 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 7 oocytes retrieved | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 8 oocytes retrieved | 4 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 9 oocytes retrieved | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 10 oocytes retrieved | 3 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 11 oocytes retrieved | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 12 oocytes retrieved | 4 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 13 oocytes retrieved | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 14 oocytes retrieved | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 15 oocytes retrieved | 3 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 16 oocytes retrieved | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 17-18 oocytes retrieved | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 19 oocytes retrieved | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 20 oocytes retrieved | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 21 oocytes retrieved | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Oocytes Retrieved | 22 oocytes retrieved | 0 participants |
Secondary
Participants With Varying Numbers of Pronuclear Stage Oocytes
Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.
Time frame: Approximately study day 15
Population: All patients treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 3 pronuclear stage oocytes | 1 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 7 pronuclear stage oocytes | 2 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 17 pronuclear stage oocytes | 0 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 8 pronuclear stage oocytes | 2 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 4 pronuclear stage oocytes | 2 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 9 pronuclear stage oocytes | 1 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 2 pronuclear stage oocytes | 8 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 10 pronuclear stage oocytes | 1 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 5 pronuclear stage oocytes | 4 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 11 pronuclear stage oocytes | 2 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 1 pronuclear stage oocyte | 1 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 12 pronuclear stage oocytes | 0 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 6 pronuclear stage oocytes | 1 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 13 pronuclear stage oocytes | 0 participants |
| Menotrophin | Participants With Varying Numbers of Pronuclear Stage Oocytes | 14-16 pronuclear stage oocytes | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 13 pronuclear stage oocytes | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 14-16 pronuclear stage oocytes | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 17 pronuclear stage oocytes | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 1 pronuclear stage oocyte | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 2 pronuclear stage oocytes | 6 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 3 pronuclear stage oocytes | 3 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 4 pronuclear stage oocytes | 7 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 5 pronuclear stage oocytes | 7 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 6 pronuclear stage oocytes | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 7 pronuclear stage oocytes | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 8 pronuclear stage oocytes | 2 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 9 pronuclear stage oocytes | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 10 pronuclear stage oocytes | 1 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 11 pronuclear stage oocytes | 0 participants |
| Follitropin Alfa | Participants With Varying Numbers of Pronuclear Stage Oocytes | 12 pronuclear stage oocytes | 4 participants |
Secondary
Pregnancy Outcomes
Long term follow-up to determine the outcome of the pregnancy.
Time frame: Approximately 10 months
Population: All patients treated population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menotrophin | Pregnancy Outcomes | Pre-term: 1 live birth | 1 participants |
| Menotrophin | Pregnancy Outcomes | Miscarriage | 4 participants |
| Menotrophin | Pregnancy Outcomes | Full term: 1 live birth | 7 participants |
| Menotrophin | Pregnancy Outcomes | Pre-term: 2 live births | 2 participants |
| Menotrophin | Pregnancy Outcomes | Full term: 2 live births | 3 participants |
| Menotrophin | Pregnancy Outcomes | Pre-term stillbirth | 0 participants |
| Follitropin Alfa | Pregnancy Outcomes | Full term: 2 live births | 2 participants |
| Follitropin Alfa | Pregnancy Outcomes | Miscarriage | 4 participants |
| Follitropin Alfa | Pregnancy Outcomes | Pre-term: 1 live birth | 1 participants |
| Follitropin Alfa | Pregnancy Outcomes | Pre-term: 2 live births | 3 participants |
| Follitropin Alfa | Pregnancy Outcomes | Pre-term stillbirth | 1 participants |
| Follitropin Alfa | Pregnancy Outcomes | Full term: 1 live birth | 6 participants |