A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(COMPLETED)(P05788)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00702351
• Date of registration: 18/06/2008
• Primary sponsor: Schering-Plough
• Public title: A Trial of Single Dose Corifollitropin Alfa's Ability to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI (38833)(COMPLETED)(P05788) Realize
• Scientific title: A Phase II, Uncontrolled Pilot Trial to Evaluate That a Single Dose of 100 µg or 150 µg Org 36286 (Corifollitropin Alfa) is Able to Induce Multiple Follicular Growth During the First Week of Controlled Ovarian Stimulation for IVF or ICSI Using a Long Protocol of GnRH Agonist (Study 38833)
• Date of first enrolment: December 2005
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00702351
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Key inclusion & exclusion criteria

Inclusion Criteria:

- Females of couples with an indication for controlled ovarian stimulation (COS) and
IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian
response;

- >=18 and <= 39 years of age at the time of signing informed consent;

- a. First group: Body weight >= 50 kg and BMI >= 18 and <= 29 kg/m^2; b. Second group:
Body weight <= 60 kg and BMI <= 29 kg/m^2;

- Normal menstrual cycle length: 24-35 days;

- Ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);

- Normal routine diagnostic hysteroscopy and endometrial biopsy;

- Willing and able to sign informed consent.

Exclusion Criteria:

- History of or any current (treated) endocrine abnormality;

- History of ovarian hyper-response1 or history of ovarian hyperstimulation syndrome
(OHSS);

- History of or current polycystic ovary syndrome (PCOS);

- A basal antral follicle count > 20 (size < 11 mm, both ovaries combined) on USS
during the early follicular phase (menstrual cycle day 2-5);

- Less than 2 ovaries or any other ovarian abnormality;

- Presence of unilateral or bilateral hydrosalpinx (visible on USS);

- Presence of unilateral or bilateral endometriomas (>10 mm; visible on USS);

- More than three unsuccessful COS cycles since the last established ongoing pregnancy
(if applicable);

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

- FSH 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) or GnRH analogues
(e.g. hypersensitivity, pregnancy/lactation);

- Recent history of or current epilepsy, diabetes or cardiovascular, gastro-intestinal,
hepatic, renal or pulmonary disease;

- 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 screening;

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



Age minimum: 18 Years
Age maximum: 39 Years
Gender: Female

Health Condition(s) or Problem(s) studied

In Vitro Fertilization

Intervention(s)

Drug: Org 36286 (corifollitropin alfa)

Primary Outcome(s)

serum inhibin-B levels; follicle number and follicle size distribution [Time Frame: One cycle]

Secondary Outcome(s)

Amount of recFSH needed from Stimulation Day 8 onwards to the Day of hCG; Endocrinological parameters (FSH, LH, E2, P); Number and quality of oocytes retrieved [Time Frame: One cycle]

Number of fertilized oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Clinical outcome [Time Frame: One cycle]

Secondary ID(s)

38833

EudraCT #: 2004-004968-68;

P05788

Source(s) of Monetary Support

Please refer to primary and secondary sponsors