NCT02866253

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

September 19, 2019

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 10, 2016

Last Update Submit

September 17, 2019

Conditions

Infertility

Keywords

Dehydroepiandrosterone（DHEA）DOR（Diminished Ovarian Reserve)IVF(In vitro fertilization)BMP-15(Bone Morphogenetic Protein 15)

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

DHEA Group

EXPERIMENTAL

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

Drug: DHEA

Control Group

NO INTERVENTION

patients without any DHEA

Interventions

DHEADRUG

Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.

Also known as: Dehydroepiandrosterone
DHEA Group

Eligibility Criteria

Age25 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Xiao Xi Sun, PHD

    ShangHai Ji Ai Genetics & IVF Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 15, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

September 19, 2019

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share