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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: DHEA

• Registration Number: NCT02866253
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHEA Group	DHEA	DHEA 25mg t.i.d. for more than 12weeks

Primary Outcome Measures

Name	Time	Method
Implantation rate	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.