EARLY FOLLICULAR PHASE vs LUTHEAL PHASE OVARIAN STIMULATION IN BOLOGNA CRITERIA IVF/ICSI CYCLES: A RANDOMIZED COMPARATIVE SINGLE CENTER TRIAL. LUTEAL TRIA

• Conditions: Patients with diagnosis of low response (Bologna criteria) and who perform ovarian stimulation for accumulation of vitrified oocytes.; MedDRA version: 18.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-003856-31-ES
• Lead Sponsor: INSTITUTO BERNABE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

. Patient Bologna meets the criteria to be diagnosed as low responder.
2. Age under 41 years
3. Regular menstrual cycles between 21 and 35 days.
4. indication of in vitro fertilization
5. Indication of start stimulation with 300 IU of FSH
6. Presence of both ovaries
7. Ability to participate and comply with the study protocol
8. Having signed 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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Presence of follicles larger than 10 mm in the randomization visit
2. Endometriosis III / IV
3. Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome ...
4. Concurrent participation in another study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified