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NCT03317548 Clinical Trial

A Comparison of Clinical Outcomes of Warmed Embryo Vitrified at 2PN Stage and Fresh Embryo Transfers

Infertility, Female Clinical Trial

Official title:
Chung Shan Medical University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03317548
Other study ID # CS17064
Secondary ID
Status Recruiting
Phase N/A
First received October 12, 2017
Last updated October 20, 2017
Start date May 1, 2017
Est. completion date April 30, 2018

Study information
Verified date October 2017
Source Chung Shan Medical University
Contact Maw-Shang Lee, Phd
Phone 22347057
Email msleephd@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at pronuclear stage (2PN) and cultured to cleavage embryos for transfer.

This is a retrospective study. All IVF cycles were included in this study and further divided into fresh and frozen embryo transfer groups. The collection data including: stimulation protocols, medicines, blood test results, pregnancy test and all clinical data. The primary outcome is pregnancy rate and secondary outcome is implantation rate.

Description:

Study design

Study progress:

Stage 1: collection of all data from frozen embryo transfer and fresh embryo transfer groups.

Stage 2: selection data and check the delivery outcomes Stage 3: analysis data and presentation. Including criteria: all patients who underwent IVF. Excluding criteria: No. Statistics analysis: chi-test, t-test

Assessment point:

Primary endpoint: pregnancy rate Secondary endpoint: implantation rate Withdraw criteria: not application. Treatments: not application. Collection number: 500 patients. Scheduled trial period: 2017.05.01~2018.04.30

Expected research results:

The implantation rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.

The pregnancy rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.

This study is only data analysis, no additional collection of samples. This study does not involve vulnerable groups.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria:

- all patients with in vitro fertilization protocols

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• progesterone
according progesterone level to decide fresh or frozen embryo transfer
• day 3 embryo
according day 3 embryo to decide fresh or frozen embryo transfer

Locations
Country Name City State
Taiwan Chung Shan Medical University Hospital Taichung

Sponsors (1)
Lead Sponsor Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary pregnancy rate HCG test HCG test at day 15 after embryo transfer or day 18 after oocyte pick up
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