DITTO: Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

• Sponsor: University of Nottingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT01572025
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 1.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Infertility; Ovarian Aging; Diminished Ovarian Reserve (DOR); Predicted Poor-responders	Drug: Dehydroepiandrosterone; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Number of oocytes retrieved [within 15 weeks after DHEA/Placebo supplementation]

   Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.

2. Feasibility to conduct a large multicentre randomised controlled trial [with in 20 weeks of the research period (per participant)]

   Feasibility is evaluated by assessing recruitment rates and compliance of the recruited participants with DHEA/ placebo intake and follow up rates

Secondary Outcome Measures

1. Oocyte quality (clinical and molecular markers) [The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.]

   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)

2. Aneuploidy rates in the immature oocytes and unfertilized oocytes using microarray technology [The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT01572025
• Other Study ID Numbers: 11054; 2011-002425-21
• First Posted: Apr 5, 2012
• Last Update Posted: Dec 9, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Infertility; Dehydroepiandrosterone

Study Results

No Results Posted as of Dec 9, 2015