Effect of Testosterone Treatment on Embryo Quality

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Primary Ovarian Insufficiency, Female Infertility Due to Diminished Ovarian Reserve

In brief

The purpose of this study is to determine the effect of treatment with trans-dermal testosterone cream compared to placebo on measures of ovarian reserve, oocyte and embryo quality, and pregnancy rates among women with evidence of diminished ovarian reserve that have persistently low serum testosterone and free testosterone after completing six previous weeks of DHEA supplementation.

Key facts

Study ID: NCT01662466
Run by: Center for Human Reproduction
People needed: 180
Starts: 2012-07-01
Expected to finish: 2022-12-31
Last updated by the study team: 2020-11-12

Who can join

Age: 38 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women with 38 to 44 years old planning to undergo ovulation induction for IVF who are willing to sign an informed consent.
BMI > 18 and <= 30 kg/m\^2
FSH > 10 mIU/mL
AMH =< 1.05 ng/mL
Using DHEA for treatment of DOR/POA.
Baseline Total Testosterone less than 30 ng per deciliter (1.0 nmol per liter) or serum free testosterone concentrations of less than 3.5 pg per milliliter (12.1 pmol per liter), which are below the median values for normal premenopausal women (Endocrine Sciences, Calabasas Hills, Calif.).

You may not qualify if…

History of hormone dependent neoplasm
History of severe acne or hirsutism.
Hyperlipidemia.
Pre existing cardiac, renal or hepatic disease

Where it is running

Center For Human Reproduction — New York, New York, United States (enrolling)
Department of Medicine; Division of Endocrinology and Metabolism, University of Rochester School of Medicine and Dentistry — Rochester, New York, United States

Full record on ClinicalTrials.gov

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