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Completed

NCT Number: NCT01535872

Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients

The aim of this study is to show solid evidences of the efficacy of DHEA in improving the success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.

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Key information

Age range

21 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

Poor responders to IVF treatment occurs in 5-24% of in-vitro fertilisation (IVF) cycles, resulting in the cancellation of the cycle translating in very low pregnancy rate. Current interventions based upon the use of different stimulation regimen do not address the fundamental underlying physiological basis of follicular recruitment and development.

The over-riding objective of this proposal is to devise novel therapeutic approaches to the treatment of poor responders of IVF treatment through dietary supplementation with Dehydroepiandrosterone (DHEA). The investigators hypothesise that DHEA supplementation leads to improvements in ovarian steroidogenesis in poor responders, leading to improved IVF outcome. Specifically, the investigators aim to

  • Conduct a prospective randomised controlled trial (RCT) on the effects of DHEA supplementation in women who are poor responders to IVF treatment.
  • Investigate the effects of DHEA supplementation on ovarian steroidogenesis and biochemical and ultrasonographic markers of ovarian reserves.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All women who meet one of the two following Bologna criteria for poor responder: an abnormal ovarian reserve test (AMH <1.0 ng/mL or FSH >10 IU/L ), or where fewer than 4 oocytes were retrieved or fewer than 4 follicles were observed in a previous IVF stimulation cycle with either standard long or antagonist protocols
  • Where informed consent can be obtained

Exclusion criteria

  • Previous or current DHEA supplementation
  • Previous and current use of corticosteroids
  • Major systemic illnesses
  • Allergy to DHEA

Treatment and study plan

Dehydroepiandrosterone

Dietary Supplement

DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: About one month after embryo transfer

Secondary outcomes

  1. The number of oocytes retrieved at oocyte pick-up (OPU)

    Time frame: Within 3 weeks after ovarian stimulation

  2. Oocyte quality

    Time frame: Within 3 weeks after ovarian stimulation

  3. Number of embryos

    Time frame: Within 3 weeks after ovarian stimulation

  4. Quality of embryos at the end of IVF treatment

    Time frame: Within 3 weeks after ovarian stimulation

  5. The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment

    Time frame: 4 - 5 months after DHEA treatment

  6. Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU

    Time frame: 1-2 years

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.

Important dates

Study start
2012
Primary completion
2014
Study completion
2017
First posted
Feb 20, 2012
Registry last updated
Aug 7, 2018

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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