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

NCT ID: NCT03913208

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-12-31

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.

Conditions

Infertility; IVF; ICSI; Cryopreservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Will be subjected to priority to freeze

Group Type: EXPERIMENTAL

Priority to freeze

Intervention Type: PROCEDURE

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

Control group

Will receive fresh embryo transfere

Group Type: ACTIVE_COMPARATOR

Fresh embryo transfer

Intervention Type: PROCEDURE

usual strategy of giving the priority for fresh embryo transfer

Interventions

Priority to freeze

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

Intervention Type: PROCEDURE

Fresh embryo transfer

usual strategy of giving the priority for fresh embryo transfer

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ayman S Dawood, MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Elhalwagy, MD

Role: STUDY_DIRECTOR

Tanta Universit

Yaser Mesbah, MD

Role: STUDY_CHAIR

Mansiura University

Ahmed Abbas, MD

Role: STUDY_CHAIR

Assiut University

Ahmed Elsawaf, MD

Role: STUDY_CHAIR

Cairo University

Shereef Elshowaikh, MD

Role: STUDY_CHAIR

Tanta University

Abdelghaffar Dawood, MD

Role: STUDY_CHAIR

Tanta University

Ahmed Elkhyat, MD

Role: STUDY_CHAIR

Tanta University

Shereen Elbohoty, MD

Role: STUDY_CHAIR

Tanta University

Waleed Mamdouh, MD

Role: STUDY_CHAIR

Tanta University

Mahmoud Soliman, MD

Role: STUDY_CHAIR

Cairo University

Waleed Tawfeek, MD

Role: STUDY_CHAIR

Benha University

Ahmed Saber, MD

Role: STUDY_CHAIR

Benha University

Amr Abdelrahman

Role: STUDY_CHAIR

Zagazig University

Locations

Ayman Shehata Dawood

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ayman Dawood, MD

Role: CONTACT

ayman.dawood@med.tanta.edu.eg

+201020972067

Adel Elgergawy, MD

Role: CONTACT

dradelali775@gmail.com

+201002057250

Facility Contacts

Ahmed Elhalwagy

Role: primary

Other Identifiers

PCS

Identifier Type: -

Identifier Source: org_study_id