Use of Dehydroepiandrosterone (DHEA) in Women With Normal and Poor Ovarian Reserve Undergoing IVF

Female Infertility Due to Diminished Ovarian Reserve Clinical Trial

Official title:

A Randomized Controlled Trial on the Effect of Dehydroepiandrosterone (DHEA) Supplementation on Ovarian Reserve Markers, Response to a Standard Low Dose FSH Stimulation and IVF Cycle Outcomes in Patients With Normal and Poor Ovarian Reserve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915186
• Other study ID #: TY-02
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: December 19, 2013
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve markers, ovarian response to gonadotrophins and cycle outcomes in patients with normal and poor ovarian reserve.

Study Hypotheses:

1. DHEA supplementation would improve markers of ovarian reserve and ovarian response to low dose FSH stimulation in both normal and poor responders

2. DHEA supplementation would improve IVF cycle outcomes

Description:

Consecutive patients attending subfertility clinic at the Department of Obstetrics and Gynaecology, Queen Mary Hospital who are scheduled for in-vitro fertilization (IVF) treatment will be recruited and written consent will be obtained.

Baseline assessment will be performed at early follicular phase (Day 2 or 3) with hormonal tests and ultrasound.

Subjects will be divided into two groups, the normal ovarian reserve group and the poor ovarian reserve group according to AFC. Poor ovarian reserve is defined as an AFC of less than 5, while normal ovarian reserve is defined as an AFC of 5 to 15 based on a previous study showing AFC being a good predictor of ovarian response (Tomas 1997). Subjects with normal ovarian reserve will be further subdivided into <35 and >/=35 years old while subjects with poor ovarian reserve will be further subdivided into first or subsequent cycles of IVF for subgroup analysis.

Subjects in both the normal and poor ovarian reserve group will be randomized according to a computer-generated randomization list in sealed envelopes to receive either DHEA at 25mg three times a day or placebo throughout the study period.

Any changes in hormonal profile and ovarian reserve will be assessed by the above-mentioned blood tests and pelvic ultrasound scans which will be repeated at early follicle phase (Day 2 or 3) in the two subsequent cycles.

After two months of DHEA/placebo treatment, the subjects will then be given a standard low dose ovarian stimulation with 75 IU intramuscular human menopausal gonadotrophin (HMG, Menogon®, Ferring Pharmaceuticals) daily for 7 days. Blood tests and pelvic ultrasound scan will be repeated after 7 days of stimulation (ie. on day 10 or 11).

Hormonal profile and ovarian reserve will be repeated in follicular phase (D2 or 3) in the subsequent cycle, where all patients will then be offered a cycle of IVF treatment using antagonist protocol based on our standard departmental regimen. Cycle characteristic and pregnancy outcomes will be compared.

Analysis of ovarian reserve markers, ovarian response and IVF outcomes would be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Indicated for IVF treatment according to our standard department protocol

• Age < 40

• Regular menstrual cycles (21-35 days with </= 4 days inter-cycle variation)

• AFC not more than 15

Exclusion Criteria:

• Previous chemotherapy or pelvic irradiation

• Polycystic ovarian syndrome or polycystic ovaries

• On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Infertility Due to Diminished Ovarian Reserve
• Infertility, Female

Intervention

Dietary Supplement:
• Dihydroepiandrosterone (DHEA)
DHEA capsules are given at 25mg 3 times a day for 12 weeks

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Gleicher N, Barad DH. Dehydroepiandrosterone (DHEA) supplementation in diminished ovarian reserve (DOR). Reprod Biol Endocrinol. 2011 May 17;9:67. doi: 10.1186/1477-7827-9-67. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral follicle count	Compare the changes in antral follicle count after 12 weeks of DHEA supplementation prior to IVF treatment between the treatment and placebo groups	after 12 weeks of DHEA	No
Secondary	Change in Follicular stimulating hormone (FSH) and anti-Mullerian Hormone (AMH) following DHEA supplementation; post stimulation estradiol level and number of follicles > 10mm, IVF outcomes, hormonal profile of follicular fluid	Comparison on the ovarian reserve markers, response to low dose ovarian stimulation and IVF treatment outcomes between treatment and control groups	after 12 weeks of DHEA	No