Status:
COMPLETED
Clinical Trial to Assess the Effect of Testosterone in Patients With Poor Ovarian Response (TESTOPRIM)
Lead Sponsor:
Instituto de Investigacion Sanitaria La Fe
Conditions:
Infertility, Female
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 stimu...
Detailed Description
POR is a challenge for reproductive medicine because of its impact on treatment outcomes and the lack of sufficiently proven therapeutic tools. According to recent publications based on retrospective ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2019
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03378713
Start Date
August 7 2017
End Date
February 11 2019
Last Update
August 13 2019
Active Locations (1)
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1
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026