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Trial record 53 of 236 for:    PRASTERONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 31, 2013
First Posted Date  ICMJE August 2, 2013
Last Update Posted Date December 20, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
Antral follicle count [ Time Frame: after 16 weeks of DHEA ]
Compare the changes in antral follicle count after 16 weeks of DHEA supplementation prior to IVF treatment between the treatment and placebo groups
Change History Complete list of historical versions of study NCT01915186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
Change in Follicular stimulating hormone (FSH), inhibin B 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 16 weeks of DHEA ]
Comparison on the ovarian reserve markers, response to low dose ovarian stimulation and IVF treatment outcomes between treatment and control groups
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Dehydroepiandrosterone (DHEA) in Women With Normal and Poor Ovarian Reserve Undergoing IVF
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Female Infertility Due to Diminished Ovarian Reserve
Intervention  ICMJE Dietary Supplement: Dihydroepiandrosterone (DHEA)
DHEA capsules are given at 25mg 3 times a day for 12 weeks
Other Name: DHEA (GNC)
Study Arms  ICMJE
  • Experimental: Dihydroepiandrosterone (DHEA)
    DHEA 25mg 3 times a day for 12 weeks
    Intervention: Dietary Supplement: Dihydroepiandrosterone (DHEA)
  • Placebo Comparator: Placebo
    Matched placebo capsules are given 3 times a day for 12 weeks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2013)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01915186
Other Study ID Numbers  ICMJE TY-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yeung Wing Yee Tracy, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Hong Kong
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP