Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients
Dehydroepiandrosterone Treatment for Poor Responders in IVF Patients: A Prospective Randomised Controlled Trial.
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2012
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2012
CompletedFirst Posted
Study publicly available on registry
February 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedAugust 7, 2018
June 1, 2018
2.7 years
February 15, 2012
August 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
About one month after embryo transfer
Secondary Outcomes (6)
The number of oocytes retrieved at oocyte pick-up (OPU)
Within 3 weeks after ovarian stimulation
Oocyte quality
Within 3 weeks after ovarian stimulation
Number of embryos
Within 3 weeks after ovarian stimulation
Quality of embryos at the end of IVF treatment
Within 3 weeks after ovarian stimulation
The markers of ovarian reserves (AMH, follicle stimulating hormone [FSH], AFC) at the end of DHEA treatment
4 - 5 months after DHEA treatment
- +1 more secondary outcomes
Study Arms (2)
DHEA treatment
EXPERIMENTALNo treatment
NO INTERVENTIONInterventions
DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous or current DHEA supplementation
- Previous and current use of corticosteroids
- Major systemic illnesses
- Allergy to DHEA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronique Viardot-Foucault, MD, FAMS (Endocrinology)
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2012
First Posted
February 20, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2014
Study Completion
November 1, 2017
Last Updated
August 7, 2018
Record last verified: 2018-06