Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism
- Conditions
- Ovarian stimulation for oocyte donation.MedDRA version: 18.1Level: LLTClassification code 10021940Term: Infertility, female, of unspecified originSystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2015-003779-31-ES
- Lead Sponsor
- INSTITUTO BERNABE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Be considered apt to get into the oocyte donation program of Instituto Bernabeu
Age between 18 and 30 years
Body Mass Index over 18 and under 28
Antral follicle count greater than 9 and less than 25 (adding both ovaries)
Patients starting ovarian stimulation with 225 IU of FSH
Presence of both ovaries
Ability to participate and comply with the study protocol
Signing the written consent form
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 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Not suitable for inclusion in the oocyte donation program of Institute Bernabeu.
Concurrent participation in another study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method