Infertility
Conditions
Keywords
Infertility, Assisted reproductive technology
Brief summary
The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.
Interventions
DRUGGONAL f® prefilled pen
GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for 1 cycle only
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
No
Inclusion criteria
1. Female subjects justifying an in-vitro fertilization (IVF)/embryo transfer (ET) treatment 2. Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used 3. Between her 18th and 35th birthday (35 not included) at the time of the randomization visit 4. Body mass index (BMI) lower than 30 kilogram per square meter (kg/m\^2) where the BMI is calculated according to the formula 5. Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length 6. Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal to 12 International Unit per Liter (IU/L) measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start) 7. Presence of both ovaries 8. Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy 9. Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to randomization 10. Have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy 11. Willing and able to comply with the protocol for the duration of the trial 12. Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
Exclusion criteria
1. Have greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or lower than or equal to 3 oocytes collected) or have greater than or equal to 2 previous ART cycles with a hyper response (defined as greater than or equal to 25 oocytes retrieved) 2. Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's Medical responsible 3. Have previous severe ovarian hyperstimulation syndrome (OHSS) 4. Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS 5. Presence of endometriosis requiring treatment 6. Uterine myoma requiring treatment 7. Any contraindication to being pregnant and/or carrying a pregnancy to term 8. Extra-uterine pregnancy within the last 3 months prior to screening 9. History of 3 or more miscarriages (early or late miscarriages) due to any cause 10. Tumors of the hypothalamus and pituitary gland 11. Ovarian enlargement or cyst of unknown etiology 12. Ovarian, uterine or mammary cancer 13. A clinically significant systemic disease 14. Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner, 15. Abnormal gynecological bleeding of undetermined origin 16. Known allergy or hypersensitivity to human gonadotrophin preparations, 17. Any active substance abuse or history of drug medication or alcohol abuse in the past 5 years prior to the screening visit 18. Entered previously into this trial or simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oocytes Retrieved Per Participant | 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU) | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean GONAL-f® Daily Dose | Start of treatment until end of stimulation cycle (approximately 28 days) | — |
| Total Number of GONAL-f® Stimulation Treatment Days | Start of treatment until end of stimulation cycle (approximately 28 days) | — |
| Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment | Start of treatment until Day 15-20 post-hCG | Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment. |
| Percentage of Participants With Biochemical Pregnancies | Start of treatment until Day 15-20 Post-hCG | Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy. |
| Number of Participants With Fetal Sacs and Fetal Hearts | Day 35-42 Post-hCG | Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy. |
| Total GONAL-f® Dose | Start of treatment until end of stimulation cycle (approximately 28 days) | — |
| Number of Participants With Multiple Pregnancies | Day 35-42 Post-hCG | Multiple pregnancy was defined as 2 or more fetal hearts with activity. |
| Serum Progesterone (P4) Levels | End of stimulation cycle (approximately 28 days) | — |
| Percentage of Participants With Clinical Pregnancy | Day 35-42 Post-hCG | Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG. |
| Number of Participants With OHSS | Start of treatment until Day 15-20 Post-hCG | OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
| Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | up to 9 month (following the end of treatment) | Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up). |
| Implantation Rate | Day 35-42 Post-hCG | Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. |
Countries
Switzerland
Participant flow
Recruitment details
Participants were enrolled at 22 clinical trial centers in 9 European countries and 1 center in Chile. Recruitment period: 29 August 2008 to 21 January 2010.
Pre-assignment details
A total of 244 participants gave informed consent and were screened for study entry. Forty-four (44) of these participants were not randomized due to: screening failure (38), failure to down regulate (3), or other reasons (3). A total of 200 participants were randomized to one of the two treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| GONAL-f ® CONSORT Calculator GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle. | 96 |
| GONAL-f ® Standard Treatment GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice. | 104 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | All embryos discarded | 0 | 3 |
| Overall Study | Lack of ovarian response to stimulation | 9 | 5 |
| Overall Study | No embryo cleavage | 0 | 2 |
| Overall Study | No fertilization | 2 | 2 |
| Overall Study | Ovarian hyperstimulation syndrome (OHSS) | 1 | 6 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | GONAL-f ® CONSORT Calculator | GONAL-f ® Standard Treatment | Total |
|---|---|---|---|
| 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 | 96 Participants | 104 Participants | 200 Participants |
| Age, Continuous | 30.0 years STANDARD_DEVIATION 2.9 | 30.6 years STANDARD_DEVIATION 2.6 | 30.3 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment Chile | 7 participants | 8 participants | 15 participants |
| Region of Enrollment Denmark | 26 participants | 26 participants | 52 participants |
| Region of Enrollment France | 6 participants | 5 participants | 11 participants |
| Region of Enrollment Germany | 13 participants | 16 participants | 29 participants |
| Region of Enrollment Italy | 10 participants | 10 participants | 20 participants |
| Region of Enrollment Netherlands | 5 participants | 6 participants | 11 participants |
| Region of Enrollment Spain | 4 participants | 6 participants | 10 participants |
| Region of Enrollment Sweden | 8 participants | 7 participants | 15 participants |
| Region of Enrollment Switzerland | 11 participants | 14 participants | 25 participants |
| Region of Enrollment United Kingdom | 6 participants | 6 participants | 12 participants |
| Serum Anti-Mullerian Hormone (AMH) | 2.705 nanogram/milliliter (ng/mL) STANDARD_DEVIATION 1.87 | 2.399 nanogram/milliliter (ng/mL) STANDARD_DEVIATION 1.492 | 2.551 nanogram/milliliter (ng/mL) STANDARD_DEVIATION 1.692 |
| Serum Progesterone (P4) | 2.934 nanomole/liter (nmol/L) STANDARD_DEVIATION 2.328 | 2.803 nanomole/liter (nmol/L) STANDARD_DEVIATION 2.291 | 2.868 nanomole/liter (nmol/L) STANDARD_DEVIATION 2.303 |
| Sex: Female, Male Female | 96 Participants | 104 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 96 | 48 / 104 |
| serious Total, serious adverse events | 4 / 96 | 3 / 104 |
Outcome results
Primary
Number of Oocytes Retrieved Per Participant
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Time frame: 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)
Population: The modified Intention-To-Treat (ITT) population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Number of Oocytes Retrieved Per Participant | 10.0 oocytes | Standard Deviation 5.6 |
| GONAL-f ® Standard Treatment | Number of Oocytes Retrieved Per Participant | 11.8 oocytes | Standard Deviation 5.3 |
Comparison: The null hypothesis was that the difference between the mean number of oocytes \[CONSORT calculator dosing - Standard dosing\] was less than or equal to \[=\<\] (-3). The alternate hypothesis was that the difference was greater than \[\>\] (-3).p-value: 0.03795% CI: [-3.3, -0.1]ANOVA
Secondary
Implantation Rate
Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Time frame: Day 35-42 Post-hCG
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Implantation Rate | 31.1 percent sacs per embryo | Standard Deviation 41.3 |
| GONAL-f ® Standard Treatment | Implantation Rate | 31.2 percent sacs per embryo | Standard Deviation 40.8 |
p-value: 0.92695% CI: [-12.3, 13.6]ANOVA
Secondary
Mean GONAL-f® Daily Dose
Time frame: Start of treatment until end of stimulation cycle (approximately 28 days)
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Mean GONAL-f® Daily Dose | 121.49 IU | Standard Deviation 22.56 |
| GONAL-f ® Standard Treatment | Mean GONAL-f® Daily Dose | 167.43 IU | Standard Deviation 30.79 |
p-value: <0.00195% CI: [-53.75, -37.46]ANOVA
Secondary
Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment
Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.
Time frame: Start of treatment until Day 15-20 post-hCG
Population: All the randomized participants were analyzed for this outcome measure (N=200).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment | Inadequate response | 9 Participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment | Excessive response (Risk of OHSS) | 1 Participants |
| GONAL-f ® Standard Treatment | Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment | Inadequate response | 5 Participants |
| GONAL-f ® Standard Treatment | Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment | Excessive response (Risk of OHSS) | 6 Participants |
Secondary
Number of Participants With Fetal Sacs and Fetal Hearts
Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.
Time frame: Day 35-42 Post-hCG
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 3 (fetal hearts) | 1 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | Missing (fetal sacs and fetal hearts) | 47 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 0 (fetal sacs) | 6 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 1 (fetal sacs) | 27 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 2 (fetal sacs) | 5 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 3 (fetal sacs) | 1 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 0 (fetal hearts) | 8 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 1 (fetal hearts) | 25 participants |
| GONAL-f ® CONSORT Calculator | Number of Participants With Fetal Sacs and Fetal Hearts | 2 (fetal hearts) | 5 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 1 (fetal hearts) | 24 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 3 (fetal sacs) | 0 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | Missing (fetal sacs and fetal hearts) | 57 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 3 (fetal hearts) | 0 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 0 (fetal sacs) | 1 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 0 (fetal hearts) | 3 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 1 (fetal sacs) | 25 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 2 (fetal hearts) | 9 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Fetal Sacs and Fetal Hearts | 2 (fetal sacs) | 10 participants |
Secondary
Number of Participants With Multiple Pregnancies
Multiple pregnancy was defined as 2 or more fetal hearts with activity.
Time frame: Day 35-42 Post-hCG
Population: The modified ITT population. Number of participants analyzed (N) signifies those participants who were evaluated for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GONAL-f ® CONSORT Calculator | Number of Participants With Multiple Pregnancies | 6 participants |
| GONAL-f ® Standard Treatment | Number of Participants With Multiple Pregnancies | 9 participants |
Secondary
Number of Participants With OHSS
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time frame: Start of treatment until Day 15-20 Post-hCG
Population: Safety population included all the participants who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GONAL-f ® CONSORT Calculator | Number of Participants With OHSS | 6 participants |
| GONAL-f ® Standard Treatment | Number of Participants With OHSS | 13 participants |
Secondary
Percentage of Participants With Biochemical Pregnancies
Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.
Time frame: Start of treatment until Day 15-20 Post-hCG
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GONAL-f ® CONSORT Calculator | Percentage of Participants With Biochemical Pregnancies | 47.7 percentage of participants |
| GONAL-f ® Standard Treatment | Percentage of Participants With Biochemical Pregnancies | 44.1 percentage of participants |
95% CI: [-11, 18.2]
Secondary
Percentage of Participants With Clinical Pregnancy
Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.
Time frame: Day 35-42 Post-hCG
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GONAL-f ® CONSORT Calculator | Percentage of Participants With Clinical Pregnancy | 36.0 percentage of participants |
| GONAL-f ® Standard Treatment | Percentage of Participants With Clinical Pregnancy | 35.5 percentage of participants |
95% CI: [-13.5, 14.6]
Secondary
Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome
Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).
Time frame: up to 9 month (following the end of treatment)
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | Live outcomes | 24 participants |
| GONAL-f ® CONSORT Calculator | Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | Non-live outcomes | 2 participants |
| GONAL-f ® CONSORT Calculator | Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | Unknown outcomes | 5 participants |
| GONAL-f ® Standard Treatment | Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | Live outcomes | 25 participants |
| GONAL-f ® Standard Treatment | Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | Non-live outcomes | 3 participants |
| GONAL-f ® Standard Treatment | Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome | Unknown outcomes | 5 participants |
Secondary
Serum Progesterone (P4) Levels
Time frame: End of stimulation cycle (approximately 28 days)
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Serum Progesterone (P4) Levels | 5.41 nmol/L | Standard Deviation 7.57 |
| GONAL-f ® Standard Treatment | Serum Progesterone (P4) Levels | 4.88 nmol/L | Standard Deviation 2.22 |
p-value: 0.23595% CI: [-0.61, 2.47]ANOVA
Secondary
Total GONAL-f® Dose
Time frame: Start of treatment until end of stimulation cycle (approximately 28 days)
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Total GONAL-f® Dose | 1288.54 IU | Standard Deviation 300.95 |
| GONAL-f ® Standard Treatment | Total GONAL-f® Dose | 1809.95 IU | Standard Deviation 546.9 |
p-value: <0.00195% CI: [-638.78, -383.96]ANOVA
Secondary
Total Number of GONAL-f® Stimulation Treatment Days
Time frame: Start of treatment until end of stimulation cycle (approximately 28 days)
Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GONAL-f ® CONSORT Calculator | Total Number of GONAL-f® Stimulation Treatment Days | 10.6 days | Standard Deviation 1.7 |
| GONAL-f ® Standard Treatment | Total Number of GONAL-f® Stimulation Treatment Days | 10.7 days | Standard Deviation 1.6 |
p-value: 0.93395% CI: [-0.4, 0.5]ANOVA