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

NCT ID: NCT03317548

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Female Reproductive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

progesterone

Intervention Type DIAGNOSTIC_TEST

according progesterone level to decide fresh or frozen embryo transfer

day 3 embryo

Intervention Type DIAGNOSTIC_TEST

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

progesterone

Intervention Type DIAGNOSTIC_TEST

according progesterone level to decide fresh or frozen embryo transfer

day 3 embryo

Intervention Type DIAGNOSTIC_TEST

according day 3 embryo to decide fresh or frozen embryo transfer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

progesterone

according progesterone level to decide fresh or frozen embryo transfer

Intervention Type DIAGNOSTIC_TEST

day 3 embryo

according day 3 embryo to decide fresh or frozen embryo transfer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patients with in vitro fertilization protocols

Exclusion Criteria

* none
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yeh

Director of The Institutional Review Board

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maw-Shang Lee, Phd

Role: STUDY_CHAIR

Lee Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Maw-Shang Lee, Phd

Role: CONTACT

Phone: 22347057

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS17064

Identifier Type: -

Identifier Source: org_study_id