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Completed

NCT Number: NCT01572025

Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

* 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

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Key information

Conditions

Infertility Diminished Ovarian Reserve (DOR) Genital Diseases Ovarian Aging Predicted Poor-responders Urogenital Diseases

Age range

23 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Nottingham University Research and Treatment Unit in Reproduction (NURTURE)

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dehydroepiandrosterone

Drug

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

Drug

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)

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 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

    Time frame: 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 outcomes

  1. Oocyte quality (clinical and molecular markers)

    Time frame: 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

    Time frame: The sample is collected at 14-16 weeks after recruitment and assessment is performed at one year.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: DITTO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 5, 2012
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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