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Trial record 29 of 235 for:    PRASTERONE

Does DHEA IVF Outcomes in Poor Responders? (DHEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066478
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Homerton University Hospital NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Infertility, Female Poor Response to Ovulation Induction Drug: Dehydroepiandrosterone Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double-blind, placebo controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
Actual Study Start Date : October 8, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

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




Primary Outcome Measures :
  1. Clinical pregnancy rates [ Time Frame: at 6-8 weeks gestation ]
    ultrasound confirmation of a foetus with a heartbeat



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066478


Contacts
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Contact: Roy Homburg 02085105211 royhomburg@gmail.com
Contact: Hassina Fureed 02085105993 h.furreed@nhs.net

Locations
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United Kingdom
Homerton Fertility Centre Recruiting
London, United Kingdom, E9 6SR
Contact: Hassina Furreed    02085105211    h.fureed@nhs.net   
Contact: Roy Homburg, FROG    02085105211    royhomburg@gmail.com   
Sponsors and Collaborators
Homerton University Hospital NHS Foundation Trust

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Responsible Party: Homerton University Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04066478     History of Changes
Other Study ID Numbers: 2017DHEA
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs