Phase 3
N=1,390
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01144416 ↗Enrolled (actual)
1,390
Serious AEs
14.3%
Results posted
Dec 2012
Primary outcome: Primary: Percentage of Participants With a Vital Pregnancy — 23.9; 26.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SCH 900962 / Corifollitropin alfa / Org 36286 (Biological); RecFSH / follitropin beta (Biological); Placebo for SCH 900962 (Drug); Placebo for recFSH (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Vital Pregnancy |
23.9; 26.9 | — |
| SECONDARY Number of Oocytes Retrieved Per Attempt |
10.7; 10.3 | — |
| SECONDARY Live Birth Rate |
21.3; 23.4 | — |
| SECONDARY Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS) |
5; 10 | 0.30 |
| SECONDARY Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event |
5; 6 | >0.999 |
Summary
The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of the number of vital pregnancies (ie, presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable).
- Female and >=35 to =18.0 to 15.0 IU/L or luteinizing hormone (LH) >12.0 IU/L during the early follicular phase.
- Positive for human immunodeficiency virus (HIV) or Hepatitis B.
- Contraindications for the use of gonadotropins or gonadotropin releasing hormone (GnRH) antagonists.
- A recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
- Smoking or recently stopped smoking (ie, within the last 3 months prior to signing informed consent).
- A recent history or presence of alcohol or drug abuse.
- The participant or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indication or for the health of the offspring.
- Prior or concomitant medications disallowed by protocol.
Data sourced from ClinicalTrials.gov (NCT01144416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.