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

Primary Purpose

Infertility, IVF, ICSI

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Priority to freeze

Fresh embryo transfer

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ayman Shehata DawoodRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

Will be subjected to priority to freeze

Will receive fresh embryo transfere

Outcomes

Primary Outcome Measures

Cumulative pregnancy rates

The number of pregnant women in both groups after 3 cycles

Secondary Outcome Measures

Failure of pregnancy

Failed ICSI

Full Information

NCT ID

NCT03913208

First Posted

April 10, 2019

Last Updated

July 15, 2023

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT03913208

Brief Title

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

Acronym

PCS

Official Title

Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles is it Going to Make the Difference?

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, IVF, ICSI, Cryopreservation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Will be subjected to priority to freeze

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Will receive fresh embryo transfere

Intervention Type

Procedure

Intervention Name(s)

Priority to freeze

Intervention Description

Priority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone.

Intervention Type

Procedure

Intervention Name(s)

Fresh embryo transfer

Intervention Description

usual strategy of giving the priority for fresh embryo transfer

Primary Outcome Measure Information:

Title

Cumulative pregnancy rates

Description

The number of pregnant women in both groups after 3 cycles

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Failure of pregnancy

Description

Failed ICSI

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayman Dawood, MD

Phone

+201020972067

ayman.dawood@med.tanta.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Adel Elgergawy, MD

Phone

+201002057250

dradelali775@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Elhalwagy, MD

Organizational Affiliation

Tanta Universit

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yaser Mesbah, MD

Organizational Affiliation

Mansiura University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed Abbas, MD

Organizational Affiliation

Assiut University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed Elsawaf, MD

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Shereef Elshowaikh, MD

Organizational Affiliation

Tanta University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Abdelghaffar Dawood, MD

Organizational Affiliation

Tanta University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed Elkhyat, MD

Organizational Affiliation

Tanta University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Shereen Elbohoty, MD

Organizational Affiliation

Tanta University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Waleed Mamdouh, MD

Organizational Affiliation

Tanta University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mahmoud Soliman, MD

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Waleed Tawfeek, MD

Organizational Affiliation

Benha University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed Saber, MD

Organizational Affiliation

Benha University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Amr Abdelrahman

Organizational Affiliation

Zagazig University

Official's Role

Study Chair

Facility Information:

Facility Name

Ayman Shehata Dawood

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Elhalwagy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will decide the type of data to share

IPD Sharing Time Frame

3 months

Learn more about this trial

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

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