A Phase 3 interventional study of Corifollitropin alfa and recFSH (follitropin beta) in Infertility, sponsored by Organon and Co. Completed. Open to female participants aged 35 Years to 42 Years. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Organon and Co · Phase 3, Interventional, and Other
The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 307 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants in Base Study P06029 received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
Biological: Corifollitropin alfa
Participants in the reference group in Base Study P06029 received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. No medication or investigational product was administered in Follow-Up Study P06031.
Biological: recFSH (follitropin beta)
Single injection of 150 μg corifollitropin alfa administered under protocol P06029
Daily recFSH 300 IU administered under protocol P06029.
Also known as: Follistim® AQ Cartridge
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Time frame: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
Time frame: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)
| Milestone | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers | Corifollitropin Alfa 150 μg Live-Born Infants | recFSH 300 IU Live-Born Infants |
|---|---|---|---|---|
| Started | 694 | 696 | 0 | 0 |
| Completed | 632 | 647 | 0 | 0 |
| Not completed | 62 | 49 | 0 | 0 |
| Milestone | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers | Corifollitropin Alfa 150 μg Live-Born Infants | recFSH 300 IU Live-Born Infants |
|---|---|---|---|---|
| Started | 157 | 150 | 0 | 0 |
| Participants with embryo transfer (et) | 151 | 147 | 0 | 0 |
| Participants with an ongoing pregnancy | 52 | 50 | 0 | 0 |
| Completed | 113 | 110 | 0 | 0 |
| Not completed | 44 | 40 | 0 | 0 |
| Milestone | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers | Corifollitropin Alfa 150 μg Live-Born Infants | recFSH 300 IU Live-Born Infants |
|---|---|---|---|---|
| Started | 0 | 0 | 61 | 56 |
| Completed | 0 | 0 | 55 | 51 |
| Not completed | 0 | 0 | 6 | 5 |
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
| Percentage of Participants | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers |
|---|---|---|
| Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) | 31.1 (27.7 to 34.7) | 33.0 (29.6 to 36.7) |
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
| Percentage of Participants | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers |
|---|---|---|
| Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) | 28.2 (24.9 to 31.8) | 29.5 (26.1 to 33.0) |
Collected over From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to 12 weeks after birth in current follow-up study (up to 2 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Corifollitropin Alfa 150 μg Participants With ET | — | 4/151 (2.6%) | 64/151 (42.4%) |
| recFSH 300 IU Participants With ET | — | 3/147 (2%) | 45/147 (30.6%) |
| Corifollitropin Alfa 150 μg Expectant Mothers | — | 34/52 (65.4%) | 26/52 (50%) |
| recFSH 300 IU Expectant Mothers | — | 29/50 (58%) | 19/50 (38%) |
| Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants | — | 15/61 (24.6%) | 18/61 (29.5%) |
| recFSH 300 IU Follow-up Fetuses/Infants | — | 17/56 (30.4%) | 21/56 (37.5%) |
| Event | Corifollitropin Alfa 150 μg Participants With ET | recFSH 300 IU Participants With ET | Corifollitropin Alfa 150 μg Expectant Mothers | recFSH 300 IU Expectant Mothers | Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants | recFSH 300 IU Follow-up Fetuses/Infants |
|---|---|---|---|---|---|---|
| Previous caesarean sectionPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 7/52 | 4/50 | 0/61 | 0/56 |
| Premature babyPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 0/52 | 0/50 | 6/61 | 7/56 |
| Breech presentationPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 3/52 | 5/50 | 0/61 | 0/56 |
| Arrested labourPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 5/52 | 3/50 | 0/61 | 0/56 |
| Caesarean sectionSurgical and medical procedures | 0/151 | 0/147 | 4/52 | 1/50 | 0/61 | 0/56 |
| Failed induction of labourPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 3/52 | 1/50 | 0/61 | 0/56 |
| Gestational hypertensionPregnancy, puerperium and perinatal conditions | 0/151 | 1/147 | 3/52 | 0/50 | 0/61 | 0/56 |
| Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/151 | 0/147 | 0/52 | 0/50 | 1/61 | 3/56 |
| Congenital umbilical herniaCongenital, familial and genetic disorders | 0/151 | 0/147 | 0/52 | 0/50 | 3/61 | 0/56 |
| Premature labourPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 1/52 | 2/50 | 0/61 | 0/56 |
| Event | Corifollitropin Alfa 150 μg Participants With ET | recFSH 300 IU Participants With ET | Corifollitropin Alfa 150 μg Expectant Mothers | recFSH 300 IU Expectant Mothers | Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants | recFSH 300 IU Follow-up Fetuses/Infants |
|---|---|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 37/151 | 22/147 | 0/52 | 0/50 | 0/61 | 0/56 |
| Jaundice neonatalPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 0/52 | 0/50 | 5/61 | 10/56 |
| HeadacheNervous system disorders | 8/151 | 5/147 | 2/52 | 6/50 | 0/61 | 0/56 |
| Premature babyPregnancy, puerperium and perinatal conditions | 0/151 | 0/147 | 0/52 | 0/50 | 7/61 | 4/56 |
| Haemorrhage in pregnancyPregnancy, puerperium and perinatal conditions | 13/151 | 15/147 | 0/52 | 0/50 | 0/61 | 0/56 |
| ConstipationGastrointestinal disorders | 0/151 | 0/147 | 5/52 | 4/50 | 0/61 | 1/56 |
| Procedural painInjury, poisoning and procedural complications | 0/151 | 0/147 | 5/52 | 4/50 | 0/61 | 0/56 |
| Vomiting in pregnancyPregnancy, puerperium and perinatal conditions | 14/151 | 11/147 | 1/52 | 3/50 | 0/61 | 0/56 |
| Hyperbilirubinaemia neonatalHepatobiliary disorders | 0/151 | 0/147 | 0/52 | 0/50 | 3/61 | 5/56 |
| DyspepsiaGastrointestinal disorders | 0/151 | 0/147 | 3/52 | 4/50 | 0/61 | 0/56 |
All Subjects Evaluable, restricted to subjects with ET
| Age, Continuous(Years) | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers | Total |
|---|---|---|---|
| Mean | 38.5 ± 2.1 | 38.3 ± 2.2 | 38.4 ± 2.2 |
| Sex: Female, Male(Participants) | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers | Total |
|---|---|---|---|
| Female | 151 | 147 | 298 |
| Male | 0 | 0 | 0 |
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Plan to share: No
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