Status:
COMPLETED
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)(P05788)
Lead Sponsor:
Organon and Co
Conditions:
In Vitro Fertilization
Eligibility:
FEMALE
18-39 years
Phase:
PHASE2
Brief Summary
To evaluate the induction of multiple follicular growth after single dose administration of 100 μg or 150 μg Org 36286 in a long protocol of GnRH agonist.
Detailed Description
In this trial, all subjects were (pre)treated daily with subcutaneous triptorelin, a GnRH agonist which is known to provide profound suppression of endogenous LH and FSH. It was evaluated whether thes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00702351
Start Date
December 9 2005
End Date
July 11 2007
Last Update
February 2 2022
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