Recruiting
Phase 1
Phase 2

Testosterone Treatment

Sponsor:

Center for Human Reproduction

Code:

NCT01662466

Conditions

Primary Ovarian Insufficiency

Female Infertility Due to Diminished Ovarian Reserve

Eligibility Criteria

Sex: Female

Age: 38 - 44

Healthy Volunteers: Not accepted

Interventions

Testosterone cream (0.5mg per gram)

DHEA

Placebo

Study Details

Brief 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.

Conditions

Primary Ovarian Insufficiency

Female Infertility Due to Diminished Ovarian Reserve

Study ID

NCT01662466

Start date

Jul 1, 2012

Status verified date

Feb, 2020

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Jun 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 38 - 44

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DHEA+Testosterone

These patients will be administered the testosterone cream along with standard DHEA supplements

placebo comparator: DHEA+Placebo

These patients will receive the placebo cream along with her DHEA supplements. In other words, no testosterone will be administered.

Interventions

Testosterone cream (0.5mg per gram)

Testosterone cream 2 gms per day applied transdermally to the left wrist to deliver 1.mg daily dose with estimated absorption of 100 ug per day testosterone

DHEA

DHEA 25mg tid

Placebo

Carrier cream without added testosterone in the identical type of pump

Primary outcome measure

  • Clinical and Ongoing Pregnancy [ Time Frame: 8 weeks post treatment initiation ]

Central Contacts and Locations

Central contacts

Jolanta Tapper, MD MS

212 994-4400jtapper@theCHR.com

Locations

Center For Human Reproduction

Recruiting

New York, New York, United States, 10021

Contacts

Jolanta Tapper

212-994-4400jtapper@theCHR.com

Principal Investigator:

David H Barad, MD MS

More Information

Sponsor

Center for Human Reproduction

Last update posted

Nov 12, 2020

Last verified

Feb, 2020

Keywords

  • testosterone
  • DHEA
  • IVF
  • egg quality
  • pregnancy rates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Human Reproduction on 2020-11-12.