Overview

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.