Effect of Testosterone Treatment on Embryo Quality

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Human Reproduction
• Collaborator: Foundation for Reproductive Medicine
• Treatments: Dehydroepiandrosterone; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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