What is the Impact of Frozen Embryo Transfer Protocol, on... | NCT06251596

Studies
What is the Impact of Frozen Embryo Transfer Protocol, on Endometrial Compaction

NCT06251596

Sponsor

Hillel Yaffe Medical Center

Status

Completed

Last Update Posted

Feb 9, 2024Actual

Enrollment

247Actual

Phase

Not provided

Conditions

Interventions

Not provided

Countries

Israel

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2021Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Feb 1, 2024

First Submission Date that Met QC Criteria

Feb 1, 2024

First Posted Date

Feb 9, 2024Actual

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

Feb 1, 2024

Last Update Posted Date

Feb 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study aims to evaluate endometrial thickness on the day of the frozen embryo transfer, compared to endometrial thickness on the last day of assessment of the endometrium before exposure to progesterone in respect to the protocols used for endometrial preparation

Detailed Description

247 FET cycles were included in the study. Records of all patients and their cryopreservation embryos were analyzed. Data collection included baseline parameters of age, BMI (kg/m2), type of infertility, parity, lifestyles, and cause of infertility, as well as treatment parameters, including number of embryos transferred, embryo quality and pregnancy outcomes.

To reflect the broad range of patients typically encountered in clinical practice, no inclusion/exclusion criteria were applied regarding baseline characteristics.

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

247Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with ovulatory cycles		Patients with ovulatory cycles
Patients with artificial cycles		Patients with artificial cycles

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endometrial compaction in each group.	Endometrial compaction in each group.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Implantation and pregnancy rates in each group	Implantation and pregnancy rates in each group	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females only

Minimum Age

20 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

250 IVF patients undergoing the return of frozen embryos

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Einat Shalom Paz, PROF	Israel Hillel Yaffe medical center	Principal Investigator
Anna Turetzky Oved, Nurse	Israel Hillel Yaffe medical center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera	Heifa Region	38810101	Israel