Effect of DHEA on Patients With Poor Ovarian Responds
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|ClinicalTrials.gov Identifier: NCT02432248|
Recruitment Status : Unknown
Verified April 2015 by The Affiliated Hospital of Inner Mongolia Medical University.
Recruitment status was: Recruiting
First Posted : May 4, 2015
Last Update Posted : May 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Subfertility||Drug: Dehydroepiandrosterone Other: placebo(medical starch)||Not Applicable|
The aim of this randomized controlled study is to compare the effect of DHEA and placebo on live birth rate in poor ovarian responders. Consecutive infertile women attending the subfertility clinic for IVF treatment will be approached. Those fulfilling the selection criteria would be recruited and a written consent will be obtained after detailed explanation and counseling.
Baseline assessment will be performed at early follicular phase (Day 2 or 3) at recruitment. Patient characteristics including age, body mass index (BMI), and smoking status would be recorded and blood test including follicular stimulating hormone (FSH), estradiol (E2), testosterone and anti-Müllerian hormone (AMH) would be checked. Pelvic scan will be performed to assess the total antral follicle count (AFC) and total ovarian volume.
Subjects will be randomized divided into two groups:
- DHEA group: Subjects will take DHEA (Vitacost) 25mg three times a day for 12 weeks prior to the start of IVF treatment.
- Placebo group: Subjects will take placebo three times a day for 12 weeks prior to the start of IVF treatment.
Ultrasound assessment will be repeated in follicular phase (D2 or 3) of every month or cycle followed by a IVF treatment using antagonist protocol based on our standard departmental regimen. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for hormonal profiles.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
DHEA is considered as health supplement and is available over the counter. Side effects are minimal at present dosage (25mg or 50mg tds).
75mg/day, PO for 90 days
Other Name: DHEA
Placebo Comparator: Placebo
Medical starch is considered as medicine components. Side effects are minimal at present dosage.
Other: placebo(medical starch)
75mg/day, PO for 90 days
- Live birth rate [ Time Frame: Participants will be followed for live birth rate up to 1 year. ]Compare the live birth rate between DHEA group and placebo group
- Pregnancy rate [ Time Frame: Participants will be followed for pregnancy rate up to 1 year. ]Compare the pregnancy rate between DHEA group and placebo group
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): NCT02432248
|Contact: Yu Wang, PHDfirstname.lastname@example.org|
|The Affiliated Hospital of Inner Mongolia Medical University||Recruiting|
|Inner Mongolia, China|
|Contact: Yu Wang, MD|
|Principal Investigator:||Yu Wang, PHD||The Affiliated Hospital of Inner Mongolia Medical University|