Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles (IVF)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
DHEA
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Dehydroepiandrosterone(DHEA), DOR(Diminished Ovarian Reserve), IVF(In vitro fertilization), BMP-15(Bone Morphogenetic Protein 15)
Eligibility Criteria
Inclusion Criteria:
- Patients with antral follicle count <5 or AMH<1.1ng/ml and a previous poor ovarian reserve (POR)(</= 3 oocytes with a conventional stimulation protocol using at least 150 IU FSH per day,at least two episodes)
Exclusion Criteria:
- Patients with polycystic ovary or polycystic ovary syndrome, patients who had previous chemotherapy, pelvic irradiation or ovarian surgery and patients on hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DHEA Group
Control Group
Arm Description
DHEA 25mg t.i.d. for more than 12weeks
patients without any DHEA
Outcomes
Primary Outcome Measures
Implantation rate
Implantation status was identified by the presence of a fetal heart beat detected with an ultrasound scan at 5 weeks after embryo transfer.
Secondary Outcome Measures
Full Information
NCT ID
NCT02866253
First Posted
August 10, 2016
Last Updated
September 17, 2019
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
1. Study Identification
Unique Protocol Identification Number
NCT02866253
Brief Title
Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles
Acronym
IVF
Official Title
Dehydroepiandrosterone (DHEA)Supplementations Pre-IVF Cycles Improve the Outcome of Diminished Ovarian Reserve(DOR)Patients by the Increased Level of BMP-15(Bone Morphogenetic Protein 15) in Follicular Micro-environment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ShangHai Ji Ai Genetics & IVF Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of pre-IVF cycles treatment with and without DHEA(Dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes obtained and IVF(in vitro fertilization) outcomes of DOR(diminished ovarian reserve) patients and the expression of BMP-15(bone morphogenetic protein 15),GDF-9(growth differentiation factor 9) and IGF-I(insulin-like growth factors-1) in follicular fluid.
Detailed Description
78 patients were enrolled according to the inclusion criterion. They were randomized into two groups, 40 were in DHEA group and 38 were in control group. The DHEA group received DHEA (Lab Hercules™) 25mg three times a day continuing more than 12 weeks prior to the start of IVF treatment till the day of egg collection and the control group got without any DHEA treatment. All of the IVF women patients were given CC(clomifene citrate)+HMG(human menopausal gonadotropin) protocol for controlled ovarian hyperstimulation. Hormonal profile including E2(estradiol),FSH(follicle-stimulating hormone) ,P(progesterone) ,LH (luteinizing hormone),T(testosterone),AFC(antral follicle account),serum and follicle AMH(anti-Mullerian hormone)levels will be repeated in follicular phase (D2 or 3) of cycle followed by an IVF treatment using CC+HMG protocol based on our standard departmental regimen. Improvement of ovarian reserve markers would be assessed by the change in serum and follicle AMH levels. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for the test of DHEA-S(Dehydroepiandrosterone sulfate) and IGF-I. BMP-15 and GDF-9 expression in the follicular fluid were detected with western blot.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Dehydroepiandrosterone(DHEA), DOR(Diminished Ovarian Reserve), IVF(In vitro fertilization), BMP-15(Bone Morphogenetic Protein 15)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHEA Group
Arm Type
Experimental
Arm Description
DHEA 25mg t.i.d. for more than 12weeks
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
patients without any DHEA
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
Dehydroepiandrosterone
Intervention Description
Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.
Primary Outcome Measure Information:
Title
Implantation rate
Description
Implantation status was identified by the presence of a fetal heart beat detected with an ultrasound scan at 5 weeks after embryo transfer.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with antral follicle count <5 or AMH<1.1ng/ml and a previous poor ovarian reserve (POR)(</= 3 oocytes with a conventional stimulation protocol using at least 150 IU FSH per day,at least two episodes)
Exclusion Criteria:
Patients with polycystic ovary or polycystic ovary syndrome, patients who had previous chemotherapy, pelvic irradiation or ovarian surgery and patients on hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Xi Sun, PHD
Organizational Affiliation
ShangHai Ji Ai Genetics & IVF Institute
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles
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