Clinical Trial to Assess the Effect of Testosterone in Patients With Poor Ovarian Response (TESTOPRIM)

• Status: Completed
• Trial end date: 2019-02-11
• Target enrollment: 0
• Participant gender: Female

Summary

Trial to determine the absolute and relative efficacy of two follicular preparation regimens with transdermal testosterone during the cycle (s) prior to the initiation of COS (controlled ovarian stimulation) in patients diagnosed with POR (poor ovarian response) for the increase in the number of mature oocytes recovered.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Signed Informed consent prior to the completion of any procedure related to the clinical trial.

• Female older than 18 years old at the time of randomization.

• 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).

Exclusion Criteria:

• 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> 35 kg / m2