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Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

NCT ID: NCT01572025

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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* 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

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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.

Conditions

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Infertility Ovarian Aging Diminished Ovarian Reserve (DOR) Predicted Poor-responders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DHEA supplementation

Group Type EXPERIMENTAL

Dehydroepiandrosterone

Intervention Type DRUG

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)

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

23 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kannamannadiar Jayaprakasan, MRCOG,PhD.

Role: PRINCIPAL_INVESTIGATOR

Division of Obstetrics and Gynaecology, School of Clinical Sciences, University of Nottingham

Bruce Campbell, PhD, DSc

Role: STUDY_DIRECTOR

University of Nottingham

Nick Raine-Fenning, MRCOG, PhD

Role: STUDY_DIRECTOR

University of Nottingham

Locations

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Nottingham University Research and Treatment Unit in Reproduction (NURTURE)

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25296654 (View on PubMed)

Other Identifiers

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2011-002425-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11054

Identifier Type: -

Identifier Source: org_study_id