Clinical trial NCT02432248: 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
Overall status: RECRUITING
Phase: NA
Conditions: Subfertility
Keywords: DHEA
live birth rate
poor ovarian responder
Lead sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Renmin Hospital of Wuhan University
First posted: 2015-05-04
Enrollment: 350
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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)

Primary outcomes:
measure: Live birth rate
timeFrame: Participants will be followed for live birth rate up to 1 year.
Secondary outcomes:
measure: Pregnancy rate
timeFrame: Participants will be followed for pregnancy rate up to 1 year.
Other outcomes:
Locations:
city: Inner Mongolia
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
Study officials:
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Yu Wang, PHD
role: PRINCIPAL_INVESTIGATOR
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