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

Primary Purpose

Infertility, Ovarian Aging, Diminished Ovarian Reserve (DOR)

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Dehydroepiandrosterone
Placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

23 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Nottingham University Research and Treatment Unit in Reproduction (NURTURE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHEA supplementation

Control

Arm Description

Outcomes

Primary Outcome Measures

Number of oocytes retrieved
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
Feasibility to conduct a large multicentre randomised controlled trial
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)
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

Full Information

First Posted
March 19, 2012
Last Updated
December 8, 2015
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT01572025
Brief Title
Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging
Acronym
DITTO
Official Title
Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Ovarian Aging, Diminished Ovarian Reserve (DOR), Predicted Poor-responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHEA supplementation
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
Time Frame
within 15 weeks after DHEA/Placebo supplementation
Title
Feasibility to conduct a large multicentre randomised controlled trial
Description
Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates
Time Frame
with in 20 weeks of the research period (per participant)
Secondary Outcome Measure Information:
Title
Oocyte quality (clinical and molecular markers)
Description
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)
Time Frame
The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kannamannadiar Jayaprakasan, MRCOG,PhD.
Organizational Affiliation
Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Campbell, PhD, DSc
Organizational Affiliation
University of Nottingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nick Raine-Fenning, MRCOG, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Study Director
Facility Information:
Facility Name
Nottingham University Research and Treatment Unit in Reproduction (NURTURE)
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25296654
Citation
Jayaprakasan K, Narkwichean A, Maalouf WE, Campbell BK. Efficacy of dehydroepiandrosterone to overcome the effect of ovarian ageing (DITTO): a proof of principle randomised controlled trial protocol. BMJ Open. 2014 Oct 8;4(10):e005767. doi: 10.1136/bmjopen-2014-005767.
Results Reference
derived

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Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

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