Controlled Ovarian Stimulation (COS) to induce the development of multiple follicles in patients participating in an Assisted Reproductive Technology (ART) program
Conditions
Interventions
Trade Name: Puregon 300 IU/0.36 ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: follitropin beta
CAS Number: 169108-34-3
Current Sponsor code: recFSH
Other d
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females of couples with an indication for COS and IVF and/or ICSI scheduled for their first COS cycle; 2. =18 and =39 years of age at the time of signing informed consent; 3. BMI =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
Exclusion criteria
Exclusion criteria: 1. History of/or any current (treated) endocrine abnormality; 2. Less than 2 ovaries or any other ovarian abnormality (including endometrioma >10 mm; visible on USS); 3. Presence of unilateral or bilateral hydrosalphinx (visible on USS); 4. Presence of any clinically relevant pathology affecting the uterine cavity upon discretion of the investigator or fibroids = 5 cm; 5. History of recurrent miscarriage (3 or more, even when unexplained) 6. 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); 7. Any clinically relevant abnormal laboratory value (FSH, LH, E2, P, total T, prolactin, TSH, blood biochemistry, hematology and urinalysis) based on a sample taken during the screening phase; 8. Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); 9. Contraindications for the use of contraceptive steroids; 10. Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease; 11. Abnormal karyotyping of the patient or her partner (if karyotyping is performed); 12. History or presence of alcohol or drug abuse within 12 months prior to signing informed consent; 13. Use of hormonal preparations within 1 month prior to randomization; 14. Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol; 15. Administration of investigational drugs within three months prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify a factor or group of factors capable of predicting ovarian response in women undergoing COS with a fixed daily dose of 200 IU recFSH in a GnRH antagonist regimen with or without oral contraceptive scheduling.;Secondary Objective: ;Primary end point(s): The total number of oocytes on the day of oocyte pick-up as an indication of ovarian response | — |
Countries
Denmark, France, Spain
Outcome results
None listed