Does DHEA IVF Outcomes in Poor Responders?

NCT ID: NCT04066478

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-08

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Infertility, Female Poor Response to Ovulation Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, double-blind, placebo controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Teatment

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

Group Type EXPERIMENTAL

Dehydroepiandrosterone

Intervention Type DRUG

75mg Dehydroepiandrosterone daily

Comaprator

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Dehydroepiandrosterone

75mg Dehydroepiandrosterone daily

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Homerton University Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Homerton Fertility Centre

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2017DHEA

Identifier Type: -

Identifier Source: org_study_id

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