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NCT04066478 Clinical Trial

Does DHEA IVF Outcomes in Poor Responders?

Infertility, Female Clinical Trial

— DHEA  

Official title:
Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04066478
Other study ID # 2017DHEA
Secondary ID
Status Suspended
Phase Phase 2/Phase 3
First received
Last updated
Start date October 8, 2017
Est. completion date December 31, 2022

Study information
Verified date June 2022
Source Homerton University Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment

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 information / eligibility
Status Suspended
Enrollment 400
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 42 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Dehydroepiandrosterone
75mg Dehydroepiandrosterone daily
• Placebo
Placebo

Locations
Country Name City State
United Kingdom Homerton Fertility Centre London

Sponsors (1)
Lead Sponsor Collaborator
Homerton University Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rates ultrasound confirmation of a foetus with a heartbeat at 6-8 weeks gestation
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