Suspended

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

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What is being tested

Dehydroepiandrosterone

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+4

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 40 to 42 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: October 2017
See protocol details

Summary

Principal SponsorHomerton University Hospital NHS Foundation Trust
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 8, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleDoes Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
NCT04066478
Principal SponsorHomerton University Hospital NHS Foundation Trust
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 42 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfertilityInfertility, FemaleFemale Urogenital Diseases

Criteria

3 inclusion criteria required to participate
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)

3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation

Group II

Placebo
75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Homerton Fertility Centre

London, United KingdomOpen Homerton Fertility Centre in Google Maps
SuspendedOne Study Center