Infertility, Female, Poor Response to Ovulation Induction
Conditions
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.
Interventions
DRUGDehydroepiandrosterone
75mg Dehydroepiandrosterone daily
DRUGPlacebo
Placebo
Sponsors
Homerton University Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomised, double-blind, placebo controlled study
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 42 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rates | at 6-8 weeks gestation | ultrasound confirmation of a foetus with a heartbeat |
Countries
United Kingdom
Outcome results
None listed