UnknownPhase 1/2

Effect of Testosterone Treatment on Embryo Quality

United States180 participantsStarted 2012-07-01

Plain-language summary

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.

Who can participate

Age range38 Years – 44 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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.). Exclusion Criteria: * History of hormone dependent neoplasm * History of severe acne or hirsutism. * Hyperlipidemia. * Pre existing cardiac, renal or hepatic disease

What they're measuring

Clinical and Ongoing Pregnancy

Timeframe: 8 weeks post treatment initiation

Trial details

NCT IDNCT01662466

SponsorCenter for Human Reproduction

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

Contact for this trial

Jolanta Tapper, MD MS

212 994-4400 jtapper@theCHR.com

View on ClinicalTrials.gov More Primary Ovarian Insufficiency trials