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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535872
• Other study ID #: KSHFCTG34/10
• Secondary ID: SHF/CTG034/2010
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Est. completion date: November 2017

Study information

• Verified date: June 2018
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

1. Conduct a prospective randomised controlled trial (RCT) on the effects of DHEA supplementation in women who are poor responders to IVF treatment.

2. Investigate the effects of DHEA supplementation on ovarian steroidogenesis and biochemical and ultrasonographic markers of ovarian reserves.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Poor Responder to IVF Treatment

Intervention

Dietary Supplement:
• Dehydroepiandrosterone
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		About one month after embryo transfer
Secondary	The number of oocytes retrieved at oocyte pick-up (OPU)		Within 3 weeks after ovarian stimulation
Secondary	Oocyte quality		Within 3 weeks after ovarian stimulation
Secondary	Number of embryos		Within 3 weeks after ovarian stimulation
Secondary	Quality of embryos at the end of IVF treatment		Within 3 weeks after ovarian stimulation
Secondary	The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment		4 - 5 months after DHEA treatment
Secondary	Ovarian follicular levels of estradiol, testosterone, DHEA and insulin-like growth factor 1 (IGF-1) at the time of OPU		1-2 years