Effect of DHEA on Patients With Poor Ovarian Responds
Primary Purpose
Subfertility
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dehydroepiandrosterone
placebo(medical starch)
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility focused on measuring DHEA, live birth rate, poor ovarian responder
Eligibility 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)
Sites / Locations
- The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dehydroepiandrosterone
Placebo
Arm Description
DHEA is considered as health supplement and is available over the counter. Side effects are minimal at present dosage (25mg or 50mg tds).
Medical starch is considered as medicine components. Side effects are minimal at present dosage.
Outcomes
Primary Outcome Measures
Live birth rate
Compare the live birth rate between DHEA group and placebo group
Secondary Outcome Measures
Pregnancy rate
Compare the pregnancy rate between DHEA group and placebo group
Full Information
NCT ID
NCT02432248
First Posted
March 17, 2015
Last Updated
July 18, 2023
Sponsor
The Affiliated Hospital of Inner Mongolia Medical University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT02432248
Brief Title
Effect of DHEA on Patients With Poor Ovarian Responds
Official Title
Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Inner Mongolia Medical University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
DHEA, live birth rate, poor ovarian responder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dehydroepiandrosterone
Arm Type
Experimental
Arm Description
DHEA is considered as health supplement and is available over the counter. Side effects are minimal at present dosage (25mg or 50mg tds).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Medical starch is considered as medicine components. Side effects are minimal at present dosage.
Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone
Other Intervention Name(s)
DHEA
Intervention Description
75mg/day, PO for 90 days
Intervention Type
Other
Intervention Name(s)
placebo(medical starch)
Intervention Description
75mg/day, PO for 90 days
Primary Outcome Measure Information:
Title
Live birth rate
Description
Compare the live birth rate between DHEA group and placebo group
Time Frame
Participants will be followed for live birth rate up to 1 year.
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
Compare the pregnancy rate between DHEA group and placebo group
Time Frame
Participants will be followed for pregnancy rate up to 1 year.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, PHD
Phone
86-18604718958
Email
wuai1544@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Wang, PHD
Organizational Affiliation
The Affiliated Hospital of Inner Mongolia Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Inner Mongolia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wang, MD
12. IPD Sharing Statement
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Effect of DHEA on Patients With Poor Ovarian Responds
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