Estudio aleatorizado abierto, ciego para el evaluador, de grupos paralelos, multicéntrico comparando la eficacia de MENOPUR versus FSH recombinante en estimulación controlada de ovario siguiendo un protocolo de antagonista de GnRH (Hormona Liberadora de Gonadotrofina) y transferencia embrionaria simple. - MEGASET
- Conditions
- Hiperestimulación ovárica controlada para inducir el desarrollo de folículos múltiples para técnicas de reproducción asistida (TRA).MedDRA version: 9.1Level: LLTClassification code 10021926Term: Infertility
- Registration Number
- EUCTR2008-006775-67-ES
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 660
Subjects eligible for ICSI, with the primary diagnosis of infertility being unexplained infertility or mild male factor will be included in this trial. Subjects should be 21-34 years old, have a BMI of 18-25 kg/m2, have early follicular FSH levels between 1 and 12 IU/L and antral follicle count = 10, as well as regular menstrual cycles of 24-35 days presumed to be ovulatory. Subjects must be willing to accept transfer of one blastocyst in the fresh cycle, and willing to undergo frozen embryo replacement cycles with transfer of one blastocyst per cycle within the first year after randomisation. Written informed consent must be obtained.
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
Subjects with known polycystic ovarian syndrome, known endometriosis stage I-IV or diagnosed as poor responders will be excluded.
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