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

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ClinicalTrials.gov Identifier: NCT01915186
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Yeung Wing Yee Tracy, The University of Hong Kong

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Female Infertility Due to Diminished Ovarian Reserve Dietary Supplement: Dihydroepiandrosterone (DHEA) Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dihydroepiandrosterone (DHEA)
DHEA 25mg 3 times a day for 12 weeks
 Dietary Supplement: Dihydroepiandrosterone (DHEA)
DHEA capsules are given at 25mg 3 times a day for 12 weeks
Other Name: DHEA (GNC)
Placebo Comparator: Placebo
Matched placebo capsules are given 3 times a day for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Antral follicle count [ Time Frame: after 12 weeks of DHEA ]
    Compare the changes in antral follicle count after 12 weeks of DHEA supplementation prior to IVF treatment between the treatment and placebo groups


Secondary Outcome Measures :
  1. 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 [ Time Frame: after 12 weeks of DHEA ]
    Comparison on the ovarian reserve markers, response to low dose ovarian stimulation and IVF treatment outcomes between treatment and control groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915186


Locations
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Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yeung Wing Yee Tracy, Associate Consultant, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01915186     History of Changes
Other Study ID Numbers: TY-02
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: December 2013
Keywords provided by Yeung Wing Yee Tracy, The University of Hong Kong:
DHEA
Poor ovarian reserve
Normal ovarian reserve
 In vitro fertilization treatment
Ovarian response
Pregnancy outcomes
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
 Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs