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Effect of Testosterone Treatment on Embryo Quality

NCT ID: NCT01662466

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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At CHR the investigators have been using DHEA supplementation to improve ovarian response to ovulation induction for in vitro fertilization for about five years (Barad, Brill et al. 2007; Barad, Weghofer et al .2009; Gleicher, Ryan et al. 2009; Gleicher, Weghofer et al. 2010; Gleicher and Barad 2011). Our views on the effect of androgens on the follicular environment have recently been reviewed (Gleicher, Weghofer et al. 2011). A recent analysis of androgen metabolites of DHEA in our patients suggested that women who successfully respond to DHEA supplementation with increased egg production and clinical pregnancy had testosterone above the normal median values for reproductive age women. There also appears to be a cohort of women who did not respond to DHEA and who had very low serum testosterone. The investigators decided to investigate if supplementing those women with testosterone to the normal female range would improve ovarian function and possibly increase pregnancy rates.

Recruitment \& Experimental Plan

* A baseline blood draw following completion of 6 weeks of DHEA supplementation will determine eligibility for the study. The baseline blood determinations are part of the standard pre cycle screening at CHR for all patients.
* After signing informed consent subjects will be randomly assigned to either active testosterone cream treatment or placebo.
* Active treatment will consist of a testosterone delivery system that will deliver transdermal testosterone cream(0.5 mg per gram of cream.) The cream and placebo cream will be compounded by Metro Drugs (New York, NY) and dispensed in calibrated pump that will deliver one gram of cream per stroke. Transdermal absorption is about 10% so 2 grams (1.0 mg) per day applied to the skin will deliver about 100 ug per day. In preliminary analysis we have determined that a 2 gram dose of this preparation will raise total testosterone to our target range of between 50 and 100 ng/dL.
* The dose of testosterone cream will be 2 grams of cream per day applied to the left inner forearm. The study medication will continue to be applied for 6 weeks.
* All patients with evidence of diminished ovarian reserve in our practice are treated with DHEA. Thus, patients in this study will be receiving DHEA + testosterone or DHEA + Placebo. Patients who achieve a level of serum testosterone in the desired range using DHEA alone will not be eligible for this study.

Conditions

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Primary Ovarian Insufficiency Female Infertility Due to Diminished Ovarian Reserve

Keywords

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testosterone DHEA IVF egg quality pregnancy rates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DHEA+Testosterone

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

Group Type ACTIVE_COMPARATOR

Testosterone cream (0.5mg per gram)

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

DHEA 25mg tid

DHEA+Placebo

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

Group Type PLACEBO_COMPARATOR

DHEA

Intervention Type DIETARY_SUPPLEMENT

DHEA 25mg tid

Placebo

Intervention Type DRUG

Carrier cream without added testosterone in the identical type of pump

Interventions

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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

Intervention Type DRUG

DHEA

DHEA 25mg tid

Intervention Type DIETARY_SUPPLEMENT

Placebo

Carrier cream without added testosterone in the identical type of pump

Intervention Type DRUG

Other Intervention Names

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Testosterone Dehydroepiandrosterone Carrier cream without added testosterone

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Reproductive Medicine

OTHER

Sponsor Role collaborator

Center for Human Reproduction

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norbert Gleicher, MD

Role: STUDY_CHAIR

Center for Human Reproduction

David H Barad, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Center for Human Reproduction

Locations

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Center For Human Reproduction

New York, New York, United States

Site Status RECRUITING

Department of Medicine; Division of Endocrinology and Metabolism, University of Rochester School of Medicine and Dentistry

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Jolanta Tapper, MD MS

Role: CONTACT

Phone: 212 994-4400

Email: [email protected]

Facility Contacts

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Jolanta Tapper

Role: primary

Related Links

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http://www.centerforhumanreprod.com/

Center For Human Reproduction Website

Other Identifiers

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CHR-DHEA-testosterone-2012

Identifier Type: OTHER

Identifier Source: secondary_id

072312-01

Identifier Type: -

Identifier Source: org_study_id