Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

Last updated: December 8, 2015
Sponsor: University of Nottingham
Overall Status: Completed

Phase

3

Condition

Infertility

Perimenopause

Treatment

N/A

Clinical Study ID

NCT01572025
11054
2011-002425-21
  • Ages 23-48
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged above 23 years with diminished ovarian reserve (predicted to bepoor-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

Exclusion Criteria:

  • Women with BMI >35 Kg/M2

  • Women with a single ovary

  • Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the startof 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 theeffectiveness of DHEA supplements.

Study Design

Total Participants: 60
Study Start date:
May 01, 2012
Estimated Completion Date:
December 31, 2014

Study 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.

Connect with a study center

  • Nottingham University Research and Treatment Unit in Reproduction (NURTURE)

    Nottingham, Nottinghamshire NG7 2UH
    United Kingdom

    Site Not Available

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