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

This study is currently recruiting participants.
Verified August 2012 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01572025
First received: March 19, 2012
Last updated: August 20, 2012
Last verified: August 2012
History of Changes

March 19, 2012
August 20, 2012
June 2012
September 2013   (final data collection date for primary outcome measure)
Number of oocytes retrieved and subsequent pregnancy rate [ Time Frame: within 15 weeks after DHEA/Placebo supplementation ] [ Designated as safety issue: No ]
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations. Pregnancy rate determined at week 7 after embryo transfer
Same as current
Complete list of historical versions of study NCT01572025 on ClinicalTrials.gov Archive Site
  • Oocyte quality (molecular markers) [ Time Frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year. ] [ Designated as safety issue: No ]
    Oocyte quality is 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging
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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infertility
  • Ovarian Aging
  • Diminished Ovarian Reserve (DOR)
  • Predicted Poor-responders
  • 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)
  • Experimental: DHEA supplementation
    Intervention: Drug: Dehydroepiandrosterone
  • Placebo Comparator: Control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
September 2013   (final data collection date for primary outcome measure)

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.
Female
23 Years to 48 Years
No
Contact: Kannamannadiar Jayaprakasan, MRCOG, PhD. K.Jayaprakasan@nottingham.ac.uk
Contact: Amarin Narkwichean, MD. +441158230691 Mzxan@nottingham.ac.uk
United Kingdom
 
NCT01572025
11054, 2011-002425-21
Yes
University of Nottingham
University of Nottingham
Not Provided
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
University of Nottingham
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP