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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; IVF; Cryopreservation; ICSI
• Intervention / Treatment: Procedure: Priority to freeze; Procedure: Fresh embryo transfer

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman Dawood, MD; Phone Number: +201020972067; Email: ayman.dawood@med.tanta.edu.eg
• Study Contact Backup: Name: Adel Elgergawy, MD; Phone Number: +201002057250; Email: dradelali775@gmail.com

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Ayman Shehata Dawood
    • Contact: Ahmed Elhalwagy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Will be subjected to priority to freeze	Procedure: Priority to freeze; Priority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone.
Active Comparator: Control group; Will receive fresh embryo transfere	Procedure: Fresh embryo transfer; usual strategy of giving the priority for fresh embryo transfer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of pregnancy	Failed ICSI	3 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Ahmed Elhalwagy, MD, Tanta Universit; Study Chair: Yaser Mesbah, MD, Mansiura University; Study Chair: Ahmed Abbas, MD, Assiut University; Study Chair: Ahmed Elsawaf, MD, Cairo university; Study Chair: Shereef Elshowaikh, MD, Tanta University; Study Chair: Abdelghaffar Dawood, MD, Tanta University; Study Chair: Ahmed Elkhyat, MD, Tanta University; Study Chair: Shereen Elbohoty, MD, Tanta University; Study Chair: Waleed Mamdouh, MD, Tanta University; Study Chair: Mahmoud Soliman, MD, Cairo university; Study Chair: Waleed Tawfeek, MD, Benha University; Study Chair: Ahmed Saber, MD, Benha University; Study Chair: Amr Abdelrahman, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: PCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will decide the type of data to share
• IPD Sharing Time Frame: 3 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No