A Trial of Dehydroepiandrosterone (DHEA) Treatment for in Vitro Fertilization (IVF)

Purpose
Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary and to better understand the interaction of DHEA supplementation with other treatments for ovulation induction, especially among older reproductive age women.

The specific hypothesis behind the proposed research is that DHEA is a regulator of follicular dynamics acting in the early pre-gonadotropin dependent stage of initial primordial follicle recruitment and growth.

* Clinical Pregnancy per cycle of treatment

Secondary Outcome Measures:
* Embryos per cycle of treatment
* Oocytes per cycle of treatment

Total Enrollment: 200

Study start: January 2007

Specific Aims:
Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary and to better understand the interaction of DHEA supplementation with other treatments for ovulation induction, especially among older reproductive age women.

Based on these observations the experimental focus of this project is on the interaction of DHEA adjuvant treatment with gonadotropin treatment during ovulation induction. The specific aims are designed to provide a comprehensive assessment of this effect.

1. DHEA treatment will increase pregnancy rates among women 40 to 45 years old.
2. DHEA treatment will increase antral follicle counts.
3. DHEA will lead to increased anti-mullerian (AMH) hormone levels.
4. DHEA treatment will increase mean and peak follicular phase estradiol.
5. DHEA treatment will increase the number of oocytes retrieved in IVF cycles compared to placebo.

Research Plan:
Placebo controlled randomized trial of 2 months of DHEA pretreatment prior to ovulation induction for IVF-ET.

Hypothesis 1:
Two months of DHEA pretreatment will improve the chance of pregnancy and lead to greater oocyte and embryo yields relative to placebo treated control patients.

Hypothesis 2:
Embryos produced following 2 months of pretreatment with either DHEA alone OR with DHEA plus supplemental FSH 150 units per day will result in embryos with better morphology

Hypothesis 3a-c:
Two months of DHEA pretreatment will result in:
a) increased antral follicle counts, increased AMH,
b) increased mean and peak estradiol and
c) increased oocyte production

More Info: http://clinicaltrials.gov/ct/show/NCT00419913?order=4

Category: antral follicle counts, DHEA, follicles, IVF, research