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Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

NCT01572025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-12-09

No results posted yet for this study

Summary

* To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment.
* To evaluate the feasibility of conducting a large multicentre trial

Conditions

  • Infertility
  • Ovarian Aging
  • Diminished Ovarian Reserve (DOR)
  • Predicted Poor-responders

Interventions

DRUG

Dehydroepiandrosterone

Dehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)

DRUG

Placebo

Matched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol : Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Kannamannadiar Jayaprakasan, MRCOG,PhD. · Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of Nottingham

  • Bruce Campbell, PhD, DSc · University of Nottingham

  • Nick Raine-Fenning, MRCOG, PhD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01572025 on ClinicalTrials.gov