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 range

23 Years – 48 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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