Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

Phase 3

Completed

• Conditions: Infertility; Ovarian Aging; Diminished Ovarian Reserve (DOR); Predicted Poor-responders
• Interventions: Drug: Placebo; Drug: Dehydroepiandrosterone

• Registration Number: NCT01572025
• Lead Sponsor: University of Nottingham

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.

Study Timeline

• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Study Start: 2012-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	-
DHEA supplementation	Dehydroepiandrosterone	-

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	within 15 weeks after DHEA/Placebo supplementation	Oocytes retrieved within 15 weeks after DHEA/placebo supplementations.
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

Name	Time	Method
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.
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)

Trial Locations

Locations (1)

Nottingham University Research and Treatment Unit in Reproduction (NURTURE); 🇬🇧 Nottingham, Nottinghamshire, United Kingdom