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Trial record 11 of 235 for:    PRASTERONE

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

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: DHEA Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
Experimental: DHEA Group
DHEA 25mg t.i.d. for more than 12weeks
Drug: DHEA
Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.
Other Name: Dehydroepiandrosterone

No Intervention: Control Group
patients without any DHEA



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   25 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866253


Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
Investigators
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Study Chair: Xiao Xi Sun, PHD ShangHai Ji Ai Genetics & IVF Institute

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Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT02866253     History of Changes
Other Study ID Numbers: ShangHaiJiAi-05
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ShangHai Ji Ai Genetics & IVF Institute:
Dehydroepiandrosterone(DHEA)
DOR(Diminished Ovarian Reserve)
IVF(In vitro fertilization)
BMP-15(Bone Morphogenetic Protein 15)
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs