Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)

• Status: Completed
• Trial end date: 2002-10-15
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF and IVF/ICSI. After seven days, participants were converted to treatment with Puregon® 150 IU and administration of the GnRH antagonist Orgalutran® to finalize the stimulation cycle. Secondary objectives were the safety (including the absence of antibody formation) and the direct effects of Org 36286 on reproductive functions (steroidogenesis, oocyte maturation, embryo quality and implantation).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Chorionic Gonadotropin; Ganirelix

Criteria

Inclusion Criteria:

• Females of couples with an indication for COH and IVF or IVF/ICSI;

• Body mass index (BMI) >=18 and <=29 kg/m^2;

• Normal menstrual cycle length: 24-35 days;

• Ejaculatory sperm;

Exclusion Criteria:

• History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS), or polycystic ovaries according to ultrasound scan (USS), (treated) hyperprolactinemia or evidence of ovarian dysfunction;

• More than three unsuccessful COH cycles for IVF since the last established ongoing pregnancy (if applicable);

• History of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment;

• Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual Cycle Day 2-7) as measured by the local laboratory (FSH, luteinizing hormone [LH], estradiol [E2], progesterone [P], total testosterone [T], thyroid stimulating hormone [TSH], and prolactin);

• Any clinically relevant abnormal laboratory value;

• Any ovarian and/or abdominal abnormality interfering with ultrasound examination;

• Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);

• Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;

• History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;

• Hypersensitivity to Orgalutran® or any of its components;

• Administration of investigational drugs within three months prior to screening.

• Use of hormonal preparations within one month prior to the start of Org 36286 with the exception of thyroid medication.