Randomized, Placebo-Controlled Clinical Trial of Transdermal dihydrotestosterone Gel to Improve In Vitro Fertilization Outcomes In Women With Poor Ovarian Response

Phase 1

• Conditions: Women with poor ovarian response undergoing IVF; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12615001115527
• Lead Sponsor: Prof.David Handelsman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 242

Inclusion Criteria

*Age >18 years
*Modified Bologna criteria stratified by age
-For women >40 years, no additional inclusion criteria
-For women <40 years, at least one additional inclusion criterion either previous IVF cycle with POR (<3 oocytes with conventional stimulation) and/or impaired ovarian reserve (ultrasonic antral follicle count <7 follicles or serum AMH <1.1 ng/ml)

Exclusion Criteria

*Use of androgens or pro-androgens in previous 2 months
*Perimenopausal (no regular cycle, high serum FSH)
*Major uterine abnormalities
*History of untreated systemic medical disease or organ failure (eg impaired cardiac, respiratory, hepatic, or renal function)
*Extensive skin disease that would interfere with use of the transdermal gel
*Participation in other clinical trials of medical therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of clinical pregnancies - review of medical records[End of IVF treatment cycle]