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

• Conditions: Infertility, Female; Reproductive Disorder
• Interventions: Diagnostic Test: progesterone; Diagnostic Test: day 3 embryo

• Registration Number: NCT03317548
• Lead Sponsor: Chung Shan Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-20
• Last Update Submitted: 2017-10-20
• Study First Posted: 2017-10-23
• Last Update Posted: 2017-10-23
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• all patients with in vitro fertilization protocols

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
frozen embryo transfer	progesterone	freeze-all embryo was performed after oocyte fertilization, the hormone including FSH, LH, E2 and progesterone was test before oocyte pick up and embryo transfer for analysis. vitrification of pronuclear stage embryo (zygote) and frozen embryo transfer
frozen embryo transfer	day 3 embryo	freeze-all embryo was performed after oocyte fertilization, the hormone including FSH, LH, E2 and progesterone was test before oocyte pick up and embryo transfer for analysis. vitrification of pronuclear stage embryo (zygote) and frozen embryo transfer
fresh embryo transfer	progesterone	patients with fresh day 3 embryo transfer after oocyte pick up, the hormone including FSH, LH, E2 and progesterone was test before embryo transfer for analysis. The clinical outcomes including implantation and pregnancy were checked and recorded.
fresh embryo transfer	day 3 embryo	patients with fresh day 3 embryo transfer after oocyte pick up, the hormone including FSH, LH, E2 and progesterone was test before embryo transfer for analysis. The clinical outcomes including implantation and pregnancy were checked and recorded.

Primary Outcome Measures

Name	Time	Method
pregnancy rate	HCG test at day 15 after embryo transfer or day 18 after oocyte pick up	HCG test

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan