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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
ShangHai Ji Ai Genetics & IVF Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

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

25 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    August 10, 2016
    Last Updated
    September 17, 2019
    Sponsor
    ShangHai Ji Ai Genetics & IVF Institute
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    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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