CompletedPhase 3

Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

United Kingdom60 participantsStarted 2012-05

Plain-language summary

* To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment. * To evaluate the feasibility of conducting a large multicentre trial

Who can participate

Age range23 Years – 48 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count \<10 and/or Anti-Mullerian hormone \<5pmol/L * Women undergoing IVF and IVF/ICSI treatment * Women must have a regular spontaneous menstrual cycle of 21 - 35 days Exclusion Criteria: * Women with BMI \>35 Kg/M2 * Women with a single ovary * Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment * Women with any history of seizure disorders * Women with previous participation in this trial in an earlier treatment cycle * Women with any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia * Known allergy to DHEA * Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements.

What they're measuring

Number of oocytes retrieved

Timeframe: within 15 weeks after DHEA/Placebo supplementation

Feasibility to conduct a large multicentre randomised controlled trial

Timeframe: with in 20 weeks of the research period (per participant)

Trial details

NCT IDNCT01572025

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12