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

Sponsor
Chung Shan Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03317548
Collaborator
(none)
500
1
12
41.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: progesterone
  • Diagnostic Test: day 3 embryo

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Chung Shan Medical University Hospital
Actual Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
Apr 30, 2018
Anticipated Study Completion Date :
Apr 30, 2018

Arms and Interventions

Arm Intervention/Treatment
fresh embryo transfer

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.

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

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

frozen embryo transfer

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

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

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

Outcome Measures

Primary Outcome Measures

  1. pregnancy rate [HCG test at day 15 after embryo transfer or day 18 after oocyte pick up]

    HCG test

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • all patients with in vitro fertilization protocols
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chung Shan Medical University Hospital Taichung Taiwan 40201

Sponsors and Collaborators

  • Chung Shan Medical University

Investigators

  • Study Chair: Maw-Shang Lee, Phd, Lee Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yeh, Director of The Institutional Review Board, Chung Shan Medical University
ClinicalTrials.gov Identifier:
NCT03317548
Other Study ID Numbers:
  • CS17064
First Posted:
Oct 23, 2017
Last Update Posted:
Oct 23, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2017