Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging (DITTO)

December 8, 2015 updated by: University of Nottingham

Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers.

This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham University Research and Treatment Unit in Reproduction (NURTURE)

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

23 years to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count <10 and/or Anti-Mullerian hormone <5pmol/L
  • Women undergoing IVF and IVF/ICSI treatment
  • Women must have a regular spontaneous menstrual cycle of 21 - 35 days

Exclusion Criteria:

  • Women with BMI >35 Kg/M2
  • Women with a single ovary
  • Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment
  • Women with any history of seizure disorders
  • Women with previous participation in this trial in an earlier treatment cycle
  • Women with any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia
  • Known allergy to DHEA
  • Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
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)
EXPERIMENTAL: DHEA supplementation
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: within 15 weeks after DHEA/Placebo supplementation
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
within 15 weeks after DHEA/Placebo supplementation
Feasibility to conduct a large multicentre randomised controlled trial
Time Frame: with in 20 weeks of the research period (per participant)
Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates
with in 20 weeks of the research period (per participant)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte quality (clinical and molecular markers)
Time Frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.

Clinical pregnancy rates (Pregnancy rate determined at week 5 to 7 after embryo transfer).

Molecular markers of oocyte quality as assessed by expression of cumulus cell molecular markers of oocyte competence and also by assessing energy consumption (pyruvate, lactate and glucose utilization) from the media by the oocytes and embryos (nutritional finger printing)
The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology
Time Frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.

Collaborators and Investigators

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

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Kannamannadiar Jayaprakasan, MRCOG,PhD., Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of Nottingham
  • Study Director: Bruce Campbell, PhD, DSc, University of Nottingham
  • Study Director: Nick Raine-Fenning, MRCOG, PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11054 (DAIDS ES Registry Number)
  • 2011-002425-21 (EUDRACT_NUMBER)

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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