A phase III, uncontrolled trial to assess the non-immunogenicity and safety ofOrg 36286 in patients undergoing repeated controlled ovarian stimulation cyclesusing a multiple dose GnRH antagonist protocol - Trust
- 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
- EUCTR2004-004966-34-DE
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
1. Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI;
2. =18 and = 39 years of age at the time of signing informed consent;
3. Body weight > 60 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 history of ovarian hyperstimulation syndrome (OHSS);
3. History of or current polycystic ovary syndrome (PCOS);
4. More than 20 basal antral follicles (size: <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 hydrosalpinx (visible on USS);
7. More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable);
8. History of non- or low ovarian response to FSH/hMG treatment;
9. 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);
10. Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
(including abnormal cervical smear (PAP = III, CIN =1));
11. Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation);
12. Recent history of or current epilepsy, HIV infection, Thrombophilia, diabetes or cardiovascular,
gastro-intestinal, hepatic, renal, or pulmonary disease;
13. Abnormal karyotyping of the patient or her partner (if karyotyping is performed);
14. History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
15. Previous use of Org 36286;
16. Use of hormonal preparations within 1 month prior to screening;
17. 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 assess the non-immunogenicity and safety of Org 36286 in patients undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.;Secondary Objective: ;Primary end point(s): Non-immunogenicity and safety of Org 36286
- Secondary Outcome Measures
Name Time Method