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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01572025
First received: March 19, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose
  • 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
Infertility
Ovarian Aging
Diminished Ovarian Reserve (DOR)
Predicted Poor-responders
Drug: Dehydroepiandrosterone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 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.

  Eligibility

Ages Eligible for Study:   23 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572025

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

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01572025     History of Changes
Other Study ID Numbers: 11054, 2011-002425-21
Study First Received: March 19, 2012
Last Updated: August 4, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014