A randomized, open-label clinical trial to identify predictive factors for controlled ovarian stimulation using a fixed daily dose of 200 IU of recombinant FSH in a GnRH antagonist regimen with or without oral contraceptive scheduling

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 440

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

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