Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

Infertility Clinical Trial

— DITTO  

Official title:

Efficacy of Dehydroepiandrosterone to Overcome the Effect of Ovarian Aging - A Pilot Double Blinded Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572025
• Other study ID #: 11054
• Secondary ID: 2011-002425-21
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2012
• Last updated: December 8, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 48 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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
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)

Locations

Country	Name	City	State
United Kingdom	Nottingham University Research and Treatment Unit in Reproduction (NURTURE)	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.	within 15 weeks after DHEA/Placebo supplementation	No
Primary	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	with in 20 weeks of the research period (per participant)	No
Secondary	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)	The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.	No
Secondary	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.	No