Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program MedDRA version: 7.1 Level: LLT Classification code 10017399
Conditions
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark, Germany, Hungary, Italy, Sweden
Outcome results
None listed