Does DHEA IVF Outcomes in Poor Responders?
Phase 2
Suspended
- Conditions
- Poor Response to Ovulation InductionInfertility, Female
- Interventions
- Drug: Placebo
- Registration Number
- NCT04066478
- Lead Sponsor
- Homerton University Hospital NHS Foundation Trust
- Brief Summary
This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment
- Detailed Description
Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 400
Inclusion Criteria
- Age ≥ 40 years
- Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7)
- Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol)
Exclusion Criteria
- Women > 42 years
- Women with premature ovarian failure / premature menopause (FSH>40 U/L). Women already taking DHEA.
- Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comaprator Placebo 75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation Teatment Dehydroepiandrosterone 75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation
- Primary Outcome Measures
Name Time Method Clinical pregnancy rates at 6-8 weeks gestation ultrasound confirmation of a foetus with a heartbeat
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Homerton Fertility Centre
🇬🇧London, United Kingdom