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Trial record 44 of 236 for:    PRASTERONE

Effect of DHEA on Patients With Poor Ovarian Responds

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: 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
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Renmin Hospital of Wuhan University
Information provided by (Responsible Party):
The Affiliated Hospital of Inner Mongolia Medical University

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
Subfertility Drug: Dehydroepiandrosterone Other: placebo(medical starch) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

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 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 42 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 < 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)

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): NCT02432248


Contacts
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Contact: Yu Wang, PHD 86-18604718958 wuai1544@163.com

Locations
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China
The Affiliated Hospital of Inner Mongolia Medical University Recruiting
Inner Mongolia, China
Contact: Yu Wang, MD         
Sponsors and Collaborators
The Affiliated Hospital of Inner Mongolia Medical University
First Affiliated Hospital, Sun Yat-Sen University
Renmin Hospital of Wuhan University
Investigators
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Principal Investigator: Yu Wang, PHD The Affiliated Hospital of Inner Mongolia Medical University

Publications of Results:

Other Publications:

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Responsible Party: The Affiliated Hospital of Inner Mongolia Medical University
ClinicalTrials.gov Identifier: NCT02432248    
Other Study ID Numbers: S00056W9
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015
Keywords provided by The Affiliated Hospital of Inner Mongolia Medical University:
DHEA
live birth rate
poor ovarian responder
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs