Status:
COMPLETED
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
Lead Sponsor:
Organon and Co
Conditions:
Infertility
Eligibility:
FEMALE
35-42 years
Phase:
PHASE3
Brief 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 ova...
Eligibility Criteria
Inclusion
- 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 \<=42 years of age with indication for COS and IVF/ICSI.
- Body weight ≥50.0 kg, body mass index (BMI) \>=18.0 to \<=32.0 kg/m2.
- Regular spontaneous menstrual cycle with variation not outside the 24-35 days.
- Ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed).
- Results of clinical laboratory tests, cervical smear, physical examination within normal limits or clinically acceptable to the investigator.
- Adhere to trial schedule.
Exclusion
- A recent history of/or any current endocrine abnormality.
- A history of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS).
- A history of/or current polycystic ovary syndrome.
- More than 20 basal antral follicles \<11 mm (both ovaries combined) in the early follicular phase.
- Less than 2 ovaries or any other ovarian abnormality.
- Unilateral or bilateral hydrosalpinx.
- Intrauterine fibroids ≥5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation.
- More than three unsuccessful COS cycles for IVF/ICSI since the last established ongoing pregnancy (if applicable).
- A history of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment.
- A history of recurrent miscarriage.
- FSH \>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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
1424 Patients enrolled
Trial Details
Trial ID
NCT01144416
Start Date
June 1 2010
End Date
April 1 2012
Last Update
February 3 2022
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