Effect of Testosterone Treatment on Embryo Quality
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 38 - 44 |
| Updated: | 6/14/2018 |
| Start Date: | July 2012 |
| End Date: | December 2020 |
| Contact: | Jolanta Tapper, MD MS |
| Email: | jtapper@theCHR.com |
| Phone: | 212 994-4400 |
A Randomized Double Blind Control Trial of Transdermal Testosterone Supplementation vs Placebo on Follicular Development and Atresia, Oocyte and Embryo Quality Among Women With Diminished Ovarian Reserve Undergoing in Vitro Fertilization
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.
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.
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.
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.
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
We found this trial at
2
sites
New York, New York 10021
Principal Investigator: David H Barad, MD MS
Phone: 212-994-4400
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Rochester, New York 14642
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