A phase III, randomized, double-blind, active-controlled, equivalence clinical trial to investigate the efficacy and safety of a single injection of 100 µg Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation (COS) using daily recombinant FSH (recFSH) as a reference - Ensure
- Conditions
- Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program
- Registration Number
- EUCTR2006-003811-36-CZ
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 330
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 kg and BMI = 18 and = 32 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 cysts);
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 Main Objective: To investigate the efficacy and safety of a single injection of 100 µg Org 36286 in women weighing 60 kg or less undergoing COS for IVF/ICSI, using daily recFSH as a reference.;Secondary Objective: ;Primary end point(s): The number of oocytes retrieved.
- Secondary Outcome Measures
Name Time Method