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

This study has been completed.
Information provided by (Responsible Party):
University of Nottingham Identifier:
First received: March 19, 2012
Last updated: December 8, 2015
Last verified: December 2015
  • 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

Condition Intervention Phase
Ovarian Aging
Diminished Ovarian Reserve (DOR)
Predicted Poor-responders
Drug: Dehydroepiandrosterone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial

Resource links provided by NLM:

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: within 15 weeks after DHEA/Placebo supplementation ]
    Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.

  • 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

Secondary Outcome Measures:
  • 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)

  • 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. ]

Enrollment: 60
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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)

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.


Ages Eligible for Study:   23 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01572025

United Kingdom
Nottingham University Research and Treatment Unit in Reproduction (NURTURE)
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Nottingham Identifier: NCT01572025     History of Changes
Other Study ID Numbers: 11054
2011-002425-21 ( EudraCT Number )
Study First Received: March 19, 2012
Last Updated: December 8, 2015

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors processed this record on May 25, 2017