To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)

• Status: Completed
• Trial end date: 2007-11-15
• Target enrollment: 0
• Participant gender: Female

Summary

Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Follicle Stimulating Hormone; Ganirelix; Hormones; Progesterone

Criteria

Inclusion Criteria:

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

• >=18 and <= 36 years of age at the time of signing informed consent;

• Body weight <= 60 kg and BMI >= 18 and <= 32 kg/m^2;

• Normal menstrual cycle length: 24-35 days;

• Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);

• Willing and able to sign informed consent.

Exclusion Criteria:

• History of/or any current (treated) endocrine abnormality;

• History of ovarian hyper-response or ovarian hyperstimulation syndrome

(OHSS);

• History of/or current polycystic ovary syndrome (PCOS);

• More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);

• Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);

• Presence of unilateral or bilateral hydrosalphinx (visible on USS);

• Presence of any clinically relevant pathology affecting the uterine cavity or fibroids >= 5 cm;

• More than three unsuccessful IVF cycles since the last established ongoing

pregnancy (if applicable);

• History of non- or low ovarian response to FSH/hMG treatment;

• History of recurrent miscarriage (3 or more, even when unexplained);

• FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);

• Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;

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

• Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,

gastro-intestinal, hepatic, renal or pulmonary disease;

• Abnormal karyotyping of the patient or her partner (if karyotyping is performed);

• Smoking more than 5 cigarettes per day;

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

• Previous use of Org 36286;

• Use of hormonal preparations within 1 month prior to randomization;

• Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;

• Administration of investigational drugs within three months prior to signing informed consent.