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Study of Value of Dexamethasone Used in Ovulation Induction

Primary Purpose

Infertility, Female

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexamethasone Oral Tablet
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dexamethasone group

control group

Arm Description

Outcomes

Primary Outcome Measures

cumulative pregnancy rate per oocyte retrieval cycle
cumulative pregnancy rate per oocyte retrieval cycle

Secondary Outcome Measures

Full Information

First Posted
January 29, 2018
Last Updated
January 10, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT03421041
Brief Title
Study of Value of Dexamethasone Used in Ovulation Induction
Official Title
A RCT Study of Value of Dexamethasone Used in Ovulation Induction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
protocol change
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral Tablet
Intervention Description
Dexamethasone Oral Tablet,0.75mg/tablet
Primary Outcome Measure Information:
Title
cumulative pregnancy rate per oocyte retrieval cycle
Description
cumulative pregnancy rate per oocyte retrieval cycle
Time Frame
Until 28 day after embryo transferred

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - female, 18 years old≤age≤35 years old, 18≤BMI≤25, standard patient, menstrual regularity Exclusion Criteria: 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
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

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Study of Value of Dexamethasone Used in Ovulation Induction

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