MedTrace Logo

Effect of Testosterone Treatment on Embryo Quality

NCT01662466 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-11-12

No results posted yet for this study

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

Interventions

DRUG

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

DIETARY_SUPPLEMENT

DHEA

DHEA 25mg tid

DRUG

Placebo

Carrier cream without added testosterone in the identical type of pump

Sponsors & Collaborators

  • Foundation for Reproductive Medicine

    collaborator OTHER

  • Center for Human Reproduction

    lead OTHER

Principal Investigators

  • Norbert Gleicher, MD · Center for Human Reproduction

  • David H Barad, MD, MS · Center for Human Reproduction

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
38 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-01
Primary Completion
2022-06-01
Completion
2022-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662466 on ClinicalTrials.gov