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
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 |
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
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
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
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 |
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