PRIMARY INFERTILITY MedDRA version: 20.1 Level: LLT Classification code 10016399 Term: Female infertility (primary) System Organ Class: 100000004872
Conditions
Interventions
Trade Name: MENOPUR
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: GONADOTROPINA (MENOTROPINA ALTAMENTE PURIFICADA)
CAS Number: 61489-71-2
Other descriptive n
Sponsors
Manuel Macía Cortiñas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who initiate COS therapy with GnRH agonist and ICSI. 2. Age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Endometriosis or uterine malformation 2. PCOS according to Rotterdam criteria 3. Presence of hydrosalping 4. Intolerance or allergy to drugs 5. Moderate or severe male factor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of the ovarian response.;Secondary Objective: Pregnancy rate Follicular development Serum hormonal profile at the beginning of the stimulation, in W5 and in the day of the ovulatory discharge Safety of the treatment.;Primary end point(s): Improvement of the ovarian response.;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pregnancy rate Follicular development Serum hormonal profile at the start of the stimulation, at W5 and on the day of ovulatory discharge Safety Profile;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Countries
Spain
Contacts
Public ContactClinical Operations Department
APICES SOLUCIONES SL
Outcome results
None listed