Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging - Full Text View

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:

MedlinePlus related topics: Infertility

Drug Information available for: Prasterone

U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2013 (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

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

Contacts

Contact: Kannamannadiar Jayaprakasan, MRCOG, PhD.		K.Jayaprakasan@nottingham.ac.uk
Contact: Amarin Narkwichean, MD.	+441158230691	Mzxan@nottingham.ac.uk

Locations

United Kingdom
Nottingham University Research and Treatment Unit in Reproduction (NURTURE)	Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: Kannamannadiar Jayaprakasan, MD., PhD. K.Jayaprakasan@nottingham.ac.uk
Contact: Amarin Narkwichean, MD. Mzxan@nottingham.ac.uk
Sub-Investigator: Kannamannadiar Jayaprakasan, MRCOG, PhD.
Principal Investigator: Bruce K Campbell, PhD., DSc.
Sub-Investigator: Walid Maalouf, PhD.
Sub-Investigator: Amarin Narkwichean, MD, MMedSci
Sub-Investigator: Nick Raine-Fenning, MRCOG, PhD

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 20, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Menotropins
Adjuvants, Immunologic
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013

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