Use of Dehydroepiandrosterone (DHEA) in Women With Normal and Poor Ovarian Reserve Undergoing IVF
NCT ID: NCT01915186
Last Updated: 2013-12-20
Study Results
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Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2010-10-31
2013-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Dihydroepiandrosterone (DHEA)
DHEA 25mg 3 times a day for 12 weeks
Dihydroepiandrosterone (DHEA)
DHEA capsules are given at 25mg 3 times a day for 12 weeks
Placebo
Matched placebo capsules are given 3 times a day for 12 weeks
No interventions assigned to this group
Interventions
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Dihydroepiandrosterone (DHEA)
DHEA capsules are given at 25mg 3 times a day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \< 40
* Regular menstrual cycles (21-35 days with \</= 4 days inter-cycle variation)
* AFC not more than 15
Exclusion Criteria
* Polycystic ovarian syndrome or polycystic ovaries
* On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
18 Years
40 Years
FEMALE
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Yeung Wing Yee Tracy
Associate Consultant
Locations
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University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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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.
Yeung TW, Chai J, Li RH, Lee VC, Ho PC, Ng EH. A randomized, controlled, pilot trial on the effect of dehydroepiandrosterone on ovarian response markers, ovarian response, and in vitro fertilization outcomes in poor responders. Fertil Steril. 2014 Jul;102(1):108-115.e1. doi: 10.1016/j.fertnstert.2014.03.044. Epub 2014 May 3.
Other Identifiers
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TY-02
Identifier Type: -
Identifier Source: org_study_id