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Effect of DHEA on Patients With Poor Ovarian Responds

Sponsor
The Affiliated Hospital of Inner Mongolia Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02432248
Collaborator
First Affiliated Hospital, Sun Yat-Sen University (Other), Renmin Hospital of Wuhan University (Other)
350
Enrollment
1
Location
2
Arms
34
Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of DHEA for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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:

  1. DHEA group: Subjects will take DHEA (Vitacost) 25mg three times a day for 12 weeks prior to the start of IVF treatment.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dehydroepiandrosterone

DHEA is considered as health supplement and is available over the counter. Side effects are minimal at present dosage (25mg or 50mg tds).

Drug: Dehydroepiandrosterone
75mg/day, PO for 90 days
Other Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Live birth rate [Participants will be followed for live birth rate up to 1 year.]

      Compare the live birth rate between DHEA group and placebo group

    Secondary Outcome Measures

    1. Pregnancy rate [Participants will be followed for pregnancy rate up to 1 year.]

      Compare the pregnancy rate between DHEA group and placebo group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Indicated for IVF treatment according to our standard department protocol

    • Age < 42

    • Regular menstrual cycles (21-35 days)

    Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:

    • Advanced maternal age (≥40) or any other genetic or acquired risk factor for POR

    • Previous poor ovarian response (POR) (≤3 oocytes with a conventional stimulation protocol using at least 150IU gonadotrophins per day)

    • Abnormal ovarian reserve test (i.e. AFC < 5-7 or AMH < 0.5-1.1ng/ml). Alternatively, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT.

    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

    Locations

    Site City State Country Postal Code
    1 The Affiliated Hospital of Inner Mongolia Medical University Inner Mongolia China

    Sponsors and Collaborators

    • The Affiliated Hospital of Inner Mongolia Medical University
    • First Affiliated Hospital, Sun Yat-Sen University
    • Renmin Hospital of Wuhan University

    Investigators

    • Principal Investigator: Yu Wang, PHD, The Affiliated Hospital of Inner Mongolia Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Affiliated Hospital of Inner Mongolia Medical University
    ClinicalTrials.gov Identifier:
    NCT02432248
    Other Study ID Numbers:
    • S00056W9
    First Posted:
    May 4, 2015
    Last Update Posted:
    May 4, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by The Affiliated Hospital of Inner Mongolia Medical University
    DHEA
    live birth rate
    poor ovarian responder
    Additional relevant MeSH terms:
    Infertility
    Dehydroepiandrosterone

    Study Results

    No Results Posted as of May 4, 2015