Infertility
Conditions
Keywords
Assisted reproductive treatment, Superovulation, Follitropin alfa, r-hFSH, AFOLIA
Brief summary
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
Interventions
DRUGFollitropin alfa
150IU per day subcutaneously for a maximum of 16 days
Sponsors
Finox AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Age between 20 and 38 years with regular menstrual cycles of 25-35 days * First or second cycle in the present series of ART * BMI ≥ 18 ≤ 30 kg/m2 * Basal FSH \< 10 IU/L (cycle day 2-5) * E2 levels \< 50pg/mL (\< 0.18 nmol/L) at the day of FSH administration * Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries) * Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility * Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation) * Willingness to participate in the study and to comply with the study protocol * Informed consent
Exclusion criteria
* Presence of pregnancy * History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy * Presence of clinically significant systemic disease * Presence of chronic cardiovascular, hepatic, renal or pulmonary disease * Presence of uncontrolled endocrine disorder * Previous history or presence of severe ovarian hyperstimulation syndrome * Presence of polycystic ovaries (PCO) * Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx * Neoplasia, including tumors of the hypothalamus and pituitary gland * Abnormal bleeding of undetermined origin * History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt) * Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA) * Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening * Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin) * History of drug, nicotine or alcohol abuse within the last 12 months (\> 10 cigarettes/day) * Administration of other investigational products within the last month * Clinically abnormal findings at Visit 1 * Planned PGS/PGD/PBB or assisted hatching * Concomitant participation in an other study protocol * History of extrauterine pregnancy in the previous 3 months * Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®) * Presence or history of thrombophlebitis or thromboembolic disorders * Presence or history of cerebral haemorrhage * Presence or history of porphyria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oocytes Retrieved (Per Protocol Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes |
| Number of Oocytes Retrieved (Intention-to-treat Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Day 8 of stimulation | The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point. |
| E2 Concentration at Day 8 and at Day of hCG Administration | Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment) | The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration. |
| Total Dose of r-hFSH Administered | Day of hCG administration (after maximum 16 days of r-hFSH treatment) | Total dose of r-hFSH required was assessed. |
| Quality of Oocytes Retrieved | 34-36 hours after hCG administration | Number of patients with ovum pick-up |
| Fertilisation Rate of Oocytes | 1 day after ovum pick-up | Fertilisation rate was assessed |
| Embryo Quality: Mean Number of Blastomeres | Day 2 of OPU/fertilisation | Main embryo quality parameter mean number of blastomeres |
| Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | Day 1, 2, 3 and 5 of OPU/fertilisation | — |
| Live Birth Rate | After childbirth with questionnaire | Patients with liveborn children |
| Number of Patients With Cycle Cancellation | Until child birth/miscarriage, up to the end of the study | Number of patients with cycle cancellation was assessed. |
| Number of Patients With Good Response | Until child birth/miscarriage, up to the end of the study | Good response was defined as patients with an oocyte retrieval of four or more oocytes |
| Implantation Rate | Five to six weeks after oocyte retrieval | Defined as fetal sac per embryo transferred. |
| Clinical Pregnancy Rate | Five to six weeks after oocyte retrieval | Presence of at least one intrauterine gestational sac. |
| Ongoing Pregnancy | Ten weeks after embryo transfer | Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer. |
| Clinical Pregnancy Rate (Second Treatment Cycle) | Five to six weeks after oocyte retrieval | Presence of at least one intrauterine gestational sac. |
| Ongoing Pregnancy (Second Treatment Cycle) | 10 weeks after embryo transfer | Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer. |
| Number of Days of r-hFSH Stimulation | At the day of hCG administration, up to 16 days | Mean duration of stimulation was assessed. |
| Embryo Quality: Absence of Multinucleation | Day 3 | Main embryo quality parameter absence of multinucleation observed. |
Countries
Austria, Denmark, Germany, Spain, Switzerland, United Kingdom
Participant flow
Recruitment details
Subjects were screened and enrolled at 15 centers in six European countries from July 2010 until April 2012.
Pre-assignment details
Of 460 participants in this trial 88 were reported as screening failures prior the group assignment.
Participants by arm
| Arm | Count |
|---|---|
| AFOLIA-150 (Follitropin Alfa) Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | 249 |
| Gonal-f® (Follitropin Alfa) Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days | 123 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 29 | 10 |
Baseline characteristics
| Characteristic | Gonal-f® (Follitropin Alfa) | Total | AFOLIA-150 (Follitropin Alfa) |
|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 3.76 | 31.95 years STANDARD_DEVIATION 3.9 | 31.8 years STANDARD_DEVIATION 4.02 |
| AMH less than 24 pmol/L | 47 Number of participants | 153 Number of participants | 106 Number of participants |
| Antral follicle count | 15.3 Antral follicle count | 15.2 Antral follicle count | 15.1 Antral follicle count |
| Body Mass Index | 22.4 kilogramm/ square meter | 22.6 kilogramm/ square meter | 22.7 kilogramm/ square meter |
| FSH baseline concentration | 6.9 (IU/L) | 6.9 (IU/L) | 6.9 (IU/L) |
| GnRH-agonist duration | 22.7 days | 23.1 days | 23.5 days |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 15 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) White | 117 Participants | 346 Participants | 229 Participants |
| Region of Enrollment Austria | 43 participants | 131 participants | 88 participants |
| Region of Enrollment Denmark | 37 participants | 112 participants | 75 participants |
| Region of Enrollment Germany | 11 participants | 35 participants | 24 participants |
| Region of Enrollment Spain | 19 participants | 52 participants | 33 participants |
| Region of Enrollment Switzerland | 3 participants | 11 participants | 8 participants |
| Region of Enrollment United Kingdom | 10 participants | 31 participants | 21 participants |
| Sex: Female, Male Female | 123 Participants | 372 Participants | 249 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 | 182 / 249 | 83 / 123 |
| serious Total, serious adverse events | 12 / 249 | 3 / 123 |
Outcome results
Primary
Number of Oocytes Retrieved (Intention-to-treat Population)
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Population: Intention-to-treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number of Oocytes Retrieved (Intention-to-treat Population) | 10.7 Number of retrieved oocytes | Standard Deviation 5.62 |
| Gonal-f® (Follitropin Alfa) | Number of Oocytes Retrieved (Intention-to-treat Population) | 10.4 Number of retrieved oocytes | Standard Deviation 6.14 |
p-value: 0.0003Shuirmann's TOST
Primary
Number of Oocytes Retrieved (Per Protocol Population)
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number of Oocytes Retrieved (Per Protocol Population) | 10.8 Number of retrieved oocytes | Standard Deviation 5.11 |
| Gonal-f® (Follitropin Alfa) | Number of Oocytes Retrieved (Per Protocol Population) | 10.6 Number of retrieved oocytes | Standard Deviation 6.06 |
Comparison: This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.p-value: 0.0003Shuirmann's TOST
Secondary
Clinical Pregnancy Rate
Presence of at least one intrauterine gestational sac.
Time frame: Five to six weeks after oocyte retrieval
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Clinical Pregnancy Rate | 90 Clinical pregnancies |
| Gonal-f® (Follitropin Alfa) | Clinical Pregnancy Rate | 55 Clinical pregnancies |
Secondary
Clinical Pregnancy Rate (Second Treatment Cycle)
Presence of at least one intrauterine gestational sac.
Time frame: Five to six weeks after oocyte retrieval
Population: Population with a second treatment cycle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Clinical Pregnancy Rate (Second Treatment Cycle) | 25 Clinical pregnancies |
| Gonal-f® (Follitropin Alfa) | Clinical Pregnancy Rate (Second Treatment Cycle) | 10 Clinical pregnancies |
Secondary
E2 Concentration at Day 8 and at Day of hCG Administration
The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.
Time frame: Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)
Population: All participants were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | E2 Concentration at Day 8 and at Day of hCG Administration | Day of hCG administration | 8982.3 pmol/ L | Standard Deviation 6535.3 |
| AFOLIA-150 (Follitropin Alfa) | E2 Concentration at Day 8 and at Day of hCG Administration | Day 8 | 3958.9 pmol/ L | Standard Deviation 3699.4 |
| Gonal-f® (Follitropin Alfa) | E2 Concentration at Day 8 and at Day of hCG Administration | Day of hCG administration | 7704.2 pmol/ L | Standard Deviation 5345.8 |
| Gonal-f® (Follitropin Alfa) | E2 Concentration at Day 8 and at Day of hCG Administration | Day 8 | 3234.0 pmol/ L | Standard Deviation 2428.1 |
Secondary
Embryo Quality: Absence of Multinucleation
Main embryo quality parameter absence of multinucleation observed.
Time frame: Day 3
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Embryo Quality: Absence of Multinucleation | 93.6 Percentage of absent multinucleation |
| Gonal-f® (Follitropin Alfa) | Embryo Quality: Absence of Multinucleation | 93.9 Percentage of absent multinucleation |
Secondary
Embryo Quality: Mean Number of Blastomeres
Main embryo quality parameter mean number of blastomeres
Time frame: Day 2 of OPU/fertilisation
Population: Intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Embryo Quality: Mean Number of Blastomeres | 6.6 Number of blastomeres at day 3 | Standard Deviation 2.41 |
| Gonal-f® (Follitropin Alfa) | Embryo Quality: Mean Number of Blastomeres | 6.4 Number of blastomeres at day 3 | Standard Deviation 2.49 |
Secondary
Fertilisation Rate of Oocytes
Fertilisation rate was assessed
Time frame: 1 day after ovum pick-up
Population: Intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Fertilisation Rate of Oocytes | 66.1 percentage of oocytes | Standard Deviation 24.84 |
| Gonal-f® (Follitropin Alfa) | Fertilisation Rate of Oocytes | 64.0 percentage of oocytes | Standard Deviation 24.76 |
Secondary
Implantation Rate
Defined as fetal sac per embryo transferred.
Time frame: Five to six weeks after oocyte retrieval
Population: Intention to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Implantation Rate | 31.8 Percentage of implantations |
| Gonal-f® (Follitropin Alfa) | Implantation Rate | 36.7 Percentage of implantations |
Secondary
Live Birth Rate
Patients with liveborn children
Time frame: After childbirth with questionnaire
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Live Birth Rate | 80 Patients with liveborn children |
| Gonal-f® (Follitropin Alfa) | Live Birth Rate | 51 Patients with liveborn children |
Secondary
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.
Time frame: Day 8 of stimulation
Population: All participants were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | ≥ 12 mm | 11.8 Number of follicles | Standard Deviation 4.73 |
| AFOLIA-150 (Follitropin Alfa) | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | ≥ 15 mm | 8.3 Number of follicles | Standard Deviation 3.81 |
| AFOLIA-150 (Follitropin Alfa) | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | ≥ 17 mm | 4.9 Number of follicles | Standard Deviation 3.29 |
| Gonal-f® (Follitropin Alfa) | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | ≥ 12 mm | 11.1 Number of follicles | Standard Deviation 4.23 |
| Gonal-f® (Follitropin Alfa) | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | ≥ 15 mm | 7.7 Number of follicles | Standard Deviation 3.6 |
| Gonal-f® (Follitropin Alfa) | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | ≥ 17 mm | 4.5 Number of follicles | Standard Deviation 2.71 |
p-value: 0.2357Wilcoxon (Mann-Whitney)
p-value: 0.1395Wilcoxon (Mann-Whitney)
p-value: 0.3992Wilcoxon (Mann-Whitney)
Secondary
Number of Days of r-hFSH Stimulation
Mean duration of stimulation was assessed.
Time frame: At the day of hCG administration, up to 16 days
Population: All participants were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number of Days of r-hFSH Stimulation | 10.6 days | Standard Deviation 1.91 |
| Gonal-f® (Follitropin Alfa) | Number of Days of r-hFSH Stimulation | 10.7 days | Standard Deviation 1.72 |
p-value: 0.8926Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts
Time frame: Day 1, 2, 3 and 5 of OPU/fertilisation
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | 103 Patients with cryopreservation |
| Gonal-f® (Follitropin Alfa) | Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | 55 Patients with cryopreservation |
Secondary
Number of Patients With Cycle Cancellation
Number of patients with cycle cancellation was assessed.
Time frame: Until child birth/miscarriage, up to the end of the study
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number of Patients With Cycle Cancellation | 13 Number of patients |
| Gonal-f® (Follitropin Alfa) | Number of Patients With Cycle Cancellation | 5 Number of patients |
Secondary
Number of Patients With Good Response
Good response was defined as patients with an oocyte retrieval of four or more oocytes
Time frame: Until child birth/miscarriage, up to the end of the study
Population: Intention to treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Number of Patients With Good Response | 217 Participants |
| Gonal-f® (Follitropin Alfa) | Number of Patients With Good Response | 107 Participants |
Secondary
Ongoing Pregnancy
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Time frame: Ten weeks after embryo transfer
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Ongoing Pregnancy | 84 Ongoing pregnancies |
| Gonal-f® (Follitropin Alfa) | Ongoing Pregnancy | 51 Ongoing pregnancies |
Secondary
Ongoing Pregnancy (Second Treatment Cycle)
Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.
Time frame: 10 weeks after embryo transfer
Population: Population with a second treatment cycle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Ongoing Pregnancy (Second Treatment Cycle) | 22 Ongoing pregnancies |
| Gonal-f® (Follitropin Alfa) | Ongoing Pregnancy (Second Treatment Cycle) | 9 Ongoing pregnancies |
Secondary
Quality of Oocytes Retrieved
The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).
Time frame: After oocyte retrieval, 34 to 36 hours after hCG administration
Population: Intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | Germinal vesicle | 9.5 Percentage of cells |
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | Metaphase I | 7.2 Percentage of cells |
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | Metaphase II | 83.4 Percentage of cells |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | Germinal vesicle | 9.1 Percentage of cells |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | Metaphase I | 7.7 Percentage of cells |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | Metaphase II | 83.3 Percentage of cells |
Secondary
Quality of Oocytes Retrieved
Number of patients with transferred blastocysts
Time frame: At day 4 and 5
Population: Intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | day 4 | 10 Participants |
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | day 5 | 76 Participants |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | day 4 | 2 Participants |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | day 5 | 46 Participants |
Secondary
Quality of Oocytes Retrieved
Number of embryos per blastocysts transferred
Time frame: Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval
Population: Intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | 1.5 embryos per blastocysts transferred | Standard Deviation 0.52 |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | 1.6 embryos per blastocysts transferred | Standard Deviation 0.53 |
Secondary
Quality of Oocytes Retrieved
Number of patients with ovum pick-up
Time frame: 34-36 hours after hCG administration
Population: Intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | day 2 | 82 Participants |
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | day 3 | 53 Participants |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | day 2 | 36 Participants |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | day 3 | 28 Participants |
Secondary
Quality of Oocytes Retrieved
The maturity of the cumulus oophorus was assessed.
Time frame: After oocyte retrieval, 34 to 36 hours after hCG administration
Population: Intention to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | very mature | 9.1 Percentage of cumulus oophori |
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | mature | 75.7 Percentage of cumulus oophori |
| AFOLIA-150 (Follitropin Alfa) | Quality of Oocytes Retrieved | immature | 14.5 Percentage of cumulus oophori |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | very mature | 9.4 Percentage of cumulus oophori |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | mature | 75.3 Percentage of cumulus oophori |
| Gonal-f® (Follitropin Alfa) | Quality of Oocytes Retrieved | immature | 14.2 Percentage of cumulus oophori |
Secondary
Total Dose of r-hFSH Administered
Total dose of r-hFSH required was assessed.
Time frame: Day of hCG administration (after maximum 16 days of r-hFSH treatment)
Population: All participants were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AFOLIA-150 (Follitropin Alfa) | Total Dose of r-hFSH Administered | 1555.7 IU | Standard Deviation 293 |
| Gonal-f® (Follitropin Alfa) | Total Dose of r-hFSH Administered | 1569.2 IU | Standard Deviation 259.2 |
p-value: 0.9638Wilcoxon (Mann-Whitney)