Clinical trial to assess de effect of testosterone in patients with poor ovarian response.

Phase 1

• Conditions: Infertility with Poor Ovarian Response; MedDRA version: 19.1Level: 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: EUCTR2016-004302-33-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

- Signed Informed consent prior to the completion of any procedure related to the clinical trial.
- Female, between 18 and 40 years at the time of randomization (both ages included).
-Prior diagnosis of poor ovarian response (POR) according to ESHRE Bologna criteria. Patients must meet at least 2 of the following:
• Advanced maternal age (40 years or more) or any other risk factor for POR.
• A previous POR (3 oocytes or less) with a conventional ovarian stimulation protocol.
• Abnormal ovarian reserve test (RFA <5-7 or AMH 3.3-7.9 pmol / l).
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 63
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Diagnosis of severe endometriosis (Grade III-IV).
History of previous ovarian surgery.
Presence of uterine malformations, corrected or not.
Presence of uterine pathology defined as submucous myomas or endometrial polyps, documented by transvaginal ultrasound.
Couples with severe male factor defined as REM <1 or azoospermia.
Hydrosalpinx unilateral or bilateral uncorrected.
Perimenopausal patients with irregular menstrual cycles.
Concurrent untreated endocrine disorders.
Patients who have participated in a clinical trial in a period of less than one month.
Known allergy to the drug.
Patients who have received androgen treatment within 3 months prior to inclusion in the study.
BMI> 32 kg / m2

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Determining whether a Follicular preparation with transdermal testosterone increases the number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and which testosterone administration regimen is more effective for this purpose.;Secondary Objective: To assess the effect of testosterone in its different regimens on other cycle parameters such as the number of follicles on the day of HCG, number of good quality embryos obtained or duration of stimulation.<br>To investigate the effect of testosterone on cycle outcome parameters, ie clinical gestation rate and evolutionary.<br>To compare the hormonal profiles obtained between the different groups in the different moments of measurement throughout the treatment.;Primary end point(s): Total number of mature oocytes obtained at follicular puncture.;Timepoint(s) of evaluation of this end point: 36 hours after induction of ovulation with recombinant HCG.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of obtained embryos <br>Implantation rate<br>Gestation Rate;Timepoint(s) of evaluation of this end point: 6 days after ovarian puncture.