Controlled ovarian stimulation with highly purified menotropin in low-responder patients.

Phase 1

Conditions: PRIMARY INFERTILITY
MedDRA version: 20.1Level: LLTClassification code 10016399Term: Female infertility (primary)System Organ Class: 100000004872
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2016-001590-32-ES

Lead Sponsor: Manuel Macía Cortiñas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 64

Inclusion Criteria

1. Patients who initiate COS therapy with GnRH agonist and ICSI.
2. Age <40 years with primary infertiliy including tubal factor.
3. Patients with low ovarian reserve (must meet at least two of the three Bologna criteria: RFA <7 in both ovaries, AMH <0.5-1.1 ng/dL and low response to stimulation in a previous cycle, defined as recovery of <4 oocytes or canceled cycle).
4. Normal or mild male factor (SMR=3 millions, normal morphology 4%).
5. BMI <30 kg/m2.
6. Presence of normal ovulatory cycles (every 26-35 days).
7. Patients who sign informed consent.
8. Presence of both ovaries.
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 64
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement of the ovarian response.;Secondary Objective: Pregnancy rate<br>Follicular development<br>Serum hormonal profile at the beginning of the stimulation, in W5 and in the day of the ovulatory discharge<br>Safety of the treatment.;Primary end point(s): Improvement of the ovarian response.;Timepoint(s) of evaluation of this end point: 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pregnancy rate<br>Follicular development<br>Serum hormonal profile at the start of the stimulation, at W5 and on the day of ovulatory discharge<br>Safety Profile;Timepoint(s) of evaluation of this end point: 6 weeks