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 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
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy and safety of a single injection of Org 36286 to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference.;Secondary Objective: ;Primary end point(s): Ongoing pregnancy rate assessed at least 10 weeks after embryo transfer; the number of oocytes retrieved will be analyzed as co-primary endpoint. | — |
Countries
Belgium, Czech Republic, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed