ACTRN12615001115527
Not yet recruiting
Phase 1
Randomized, Placebo-Controlled Clinical Trial of Transdermal DHT Gel to Improve IVF Outcomes In Women With Poor Ovarian Response
Prof.David Handelsman0 sites242 target enrollmentOctober 22, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prof.David Handelsman
- Enrollment
- 242
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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