A Comparison of Clinical Outcomes of Warmed Embryo Vitrif... | NCT03317548

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

NCT03317548

Sponsor

Chung Shan Medical University

Status

Unknown status

Last Update Posted

Oct 23, 2017Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Infertility, Female
Reproductive Disorder

Interventions

progesterone
day 3 embryo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Apr 30, 2018Estimated

Completion Date

Apr 30, 2018Estimated

First Submitted Date

Oct 12, 2017

First Submission Date that Met QC Criteria

Oct 20, 2017

First Posted Date

Oct 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2017

Last Update Posted Date

Oct 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yeh, Director of The Institutional Review Board, Chung Shan Medical UniversityPrincipal Investigator

Lead Sponsor

Chung Shan Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Diagnostic Test: day 3 embryo
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 Diagnostic Test: day 3 embryo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
progesterone	Diagnostic Test	according progesterone level to decide fresh or frozen embryo transfer	fresh embryo transfer frozen embryo transfer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pregnancy rate	HCG test	HCG test at day 15 after embryo transfer or day 18 after oocyte pick up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with in vitro fertilization protocols

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

all patients underwent in vitro fertilization protocols in Lee Women's Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maw-Shang Lee, Phd	Contact	22347057	1234	msleephd@gmail.com

Overall Officials

Name	Affiliation	Role
Maw-Shang Lee, Phd	Lee Women's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University Hospital	Recruiting	Taichung		40201	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided