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Does DHEA IVF Outcomes in Poor Responders? (DHEA)

Primary Purpose

Infertility, Female, Poor Response to Ovulation Induction

Status
Suspended
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Dehydroepiandrosterone
Placebo
Sponsored by
Homerton University Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

40 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Homerton Fertility Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Teatment

Comaprator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rates
ultrasound confirmation of a foetus with a heartbeat

Secondary Outcome Measures

Full Information

First Posted
August 22, 2019
Last Updated
June 17, 2022
Sponsor
Homerton University Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04066478
Brief Title
Does DHEA IVF Outcomes in Poor Responders?
Acronym
DHEA
Official Title
Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Suspended
Why Stopped
Sponsor
Study Start Date
October 8, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Homerton University Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Poor Response to Ovulation Induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised, double-blind, placebo controlled study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teatment
Arm Type
Experimental
Arm Description
75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation
Arm Title
Comaprator
Arm Type
Placebo Comparator
Arm Description
75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone
Intervention Description
75mg Dehydroepiandrosterone daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Clinical pregnancy rates
Description
ultrasound confirmation of a foetus with a heartbeat
Time Frame
at 6-8 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Homerton Fertility Centre
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom

12. IPD Sharing Statement

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Does DHEA IVF Outcomes in Poor Responders?

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