Priority to Cryopreservation Strategy (PCS) in IVF-ICSI C... | NCT03913208

Studies
Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles

NCT03913208

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Jul 18, 2023Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Infertility
IVF
ICSI
Cryopreservation

Interventions

Priority to freeze
Fresh embryo transfer

Countries

Egypt

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

Jul 2023

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, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 10, 2019

First Submission Date that Met QC Criteria

Apr 10, 2019

First Posted Date

Apr 12, 2019Actual

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

Jul 15, 2023

Last Update Posted Date

Jul 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.

Detailed Description

This study will be a non-blind, prospective, double-armed, randomized clinical trial. The study will be conducted at five centers, the Educational Hospital Fertility Unit of Tanta University, the fertility center of Cairo University, the fertility center of Assiut University, the Egyptian Consultants Fertility Center in Tanta, and MRC fertility center in Cairo from May 1st 2019 till the end of the objected number. The study will be conducted in accordance with the Declaration of Helsinki, and all participants should sign a written informed consent before inclusion in the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Will be subjected to priority to freeze	Procedure: Priority to freeze
Control group	Active Comparator	Will receive fresh embryo transfere	Procedure: Fresh embryo transfer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Priority to freeze	Procedure	Priority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative pregnancy rates	The number of pregnant women in both groups after 3 cycles	3 months

Secondary Outcomes

Measure	Description	Time Frame
Failure of pregnancy	Failed ICSI	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Candidates for IVF/ICSI
Presence of good number of embryos > 5

Exclusion Criteria:

Low quality embryos
Low ovarian reserve
Low number of embryos

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayman Dawood, MD	Contact	+201020972067		ayman.dawood@med.tanta.edu.eg
Adel Elgergawy, MD	Contact	+201002057250		dradelali775@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Elhalwagy, MD	Tanta Universit	Study Director
Yaser Mesbah, MD	Mansiura University	Study Chair
Ahmed Abbas, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ayman Shehata Dawood	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

We will decide the type of data to share

Types

Study Protocol

Time Frame

3 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided