Does DHEA IVF Outcomes in Poor Responders? (DHEA)

June 17, 2022 updated by: Homerton University Hospital NHS Foundation Trust

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

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

Study Overview

Status

Suspended

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E9 6SR
        • Homerton Fertility Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teatment
75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation
Drug: Dehydroepiandrosterone
75mg Dehydroepiandrosterone daily
Placebo Comparator: Comaprator
75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rates
Time Frame: at 6-8 weeks gestation
ultrasound confirmation of a foetus with a heartbeat
at 6-8 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Homerton University Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2017

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017DHEA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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