NCT03421041

Brief Summary

This study intends to solve the following problems: whether use dexamethasone can obviously decrease transplant cancelling probability in fresh embryo transplant cycle or not, reduce time and frequency going to hospital repeatedly for patients need frozen embryo transplant or not, and reduce the economic burden for patients or not; By comparing pregnancy rate of single transplant, hope to make clear in IVF-ET treatment for patients progesterone increases to a certain level whether it is a good choice to transfer fresh embryo after dexamethasone treatment, or frozen embryo transplant is better.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

January 29, 2018

Last Update Submit

January 10, 2022

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • cumulative pregnancy rate per oocyte retrieval cycle

    cumulative pregnancy rate per oocyte retrieval cycle

    Until 28 day after embryo transferred

Study Arms (2)

Dexamethasone group

EXPERIMENTAL
Drug: Dexamethasone Oral Tablet

control group

NO INTERVENTION

Interventions

Dexamethasone Oral TabletDRUG

Dexamethasone Oral Tablet，0.75mg/tablet

Dexamethasone group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- female, 18 years old≤age≤35 years old, 18≤BMI≤25, standard patient, menstrual regularity

You may not qualify if:

  • Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥1.0 cm, and/or endometrial hysteromyoma≤1 cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

April 1, 2018

Primary Completion

September 30, 2020

Study Completion

March 30, 2021

Last Updated

January 11, 2022

Record last verified: 2021-01

Locations

CN(1)