A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference
- Conditions
- Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) programMedDRA version: 7.1Level: LLTClassification code 10017399
- Registration Number
- EUCTR2004-004771-11-DK
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1400
1. Females of couples with an indication for COS and IVF or ICSI;
2. =18 and = 36 years of age at the time of signing informed consent;
3. Body weight > 60 and = 90 kg and BMI = 18 and = 29 kg/m2;
4. Normal menstrual cycle length: 24-35 days;
5. Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
6. Willing and able to sign informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. History of/or any current (treated) endocrine abnormality;
2. History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);
3. History of/or current polycystic ovary syndrome (PCOS);
4. 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);
5. Less than 2 ovaries or any other ovarian abnormality (including endometrioma >
10 mm; visible on USS);
6. Presence of unilateral or bilateral hydrosalphinx (visible on USS);
7. Presence of any clinically relevant pathology affecting the uterine cavity or
fibroids = 5 cm;
8. More than three unsuccessful IVF cycles since the last established ongoing
pregnancy (if applicable);
9. History of non- or low ovarian response to FSH/hMG treatment;
10. History of recurrent miscarriage (3 or more, even when unexplained);
11. 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);
12. Any clinically relevant abnormal laboratory value based on a sample taken during
the screening phase;
13. Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
undiagnosed vaginal bleeding, hypersensitivity, ovarian ysts);
14. Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,
gastro-intestinal, hepatic, renal or pulmonary disease;
15. Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
16. Smoking more than 5 cigarettes per day;
17. History or presence of alcohol or drug abuse within 12 months prior to signing
informed consent;
18. Previous use of Org 36286;
19. Use of hormonal preparations within 1 month prior to randomization;
20. Hypersensitivity to any of the concomitant medication prescribed as part of the
treatment regimen in this protocol;
21. Administration of investigational drugs within three months prior to signing
informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method