Use of Dehydroepiandrosterone (DHEA) in Women With Normal and Poor Ovarian Reserve Undergoing IVF
Condition: Female Infertility Due to Diminished Ovarian Reserve
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

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
    

Detailed 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.
    

Intervention name(s): Dihydroepiandrosterone (DHEA)
Intervention type(s): Dietary Supplement
Intervention description(s): DHEA capsules are given at 25mg 3 times a day for 12 weeks
Other intervention name(s): DHEA (GNC)
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DHEA; Poor ovarian reserve; Normal ovarian reserve; In vitro fertilization treatment; Ovarian response; Pregnancy outcomes