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Clinical Trials/ACTRN12615001115527
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.

Registry
who.int
Start Date
October 22, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Prof.David Handelsman

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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