A Phase 4 interventional study of DHEA in Infertility, sponsored by ShangHai Ji Ai Genetics & IVF Institute. Completed. Open to female participants aged 25 Years to 42 Years. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by ShangHai Ji Ai Genetics & IVF Institute · Phase 4, Interventional, and Treatment
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.
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.
2,540 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 78 is below the median of 120 across 1,722 interventional studies indexed under Infertility.
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Exclusion Criteria:
DHEA 25mg t.i.d. for more than 12weeks
Drug: DHEA
patients without any DHEA
Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.
Also known as: Dehydroepiandrosterone
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.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Dec 2014, a primary completion of Dec 2015 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dehydroepiandrosterone
ShangHai Ji Ai Genetics & IVF Institute