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Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles (IVF)

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ClinicalTrials.gov Identifier: NCT02866253
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date September 19, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Implantation rate [ Time Frame: 6 months ]
Implantation status was identified by the presence of a fetal heart beat detected with an ultrasound scan at 5 weeks after embryo transfer.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
Implantation rate [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT02866253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Drug: DHEA
Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.
Other Name: Dehydroepiandrosterone
Study Arms  ICMJE
  • Experimental: DHEA Group
    DHEA 25mg t.i.d. for more than 12weeks
    Intervention: Drug: DHEA
  • No Intervention: Control Group
    patients without any DHEA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2016)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866253
Other Study ID Numbers  ICMJE ShangHaiJiAi-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ShangHai Ji Ai Genetics & IVF Institute
Study Sponsor  ICMJE ShangHai Ji Ai Genetics & IVF Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xiao Xi Sun, PHD ShangHai Ji Ai Genetics & IVF Institute
PRS Account ShangHai Ji Ai Genetics & IVF Institute
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP