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

NCT03913208 | Unknown

• 1 other identifier: PCS
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; IVF; ICSI; Cryopreservation

Outcome Measures

Primary Outcomes (1)

• Cumulative pregnancy rates

  The number of pregnant women in both groups after 3 cycles

  3 months

Secondary Outcomes (1)

• Failure of pregnancy

  3 months

Study Arms (2)

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

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.

Study group

Fresh embryo transfer PROCEDURE

usual strategy of giving the priority for fresh embryo transfer

Control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Low quality embryos
• Low ovarian reserve
• Low number of embryos

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ayman Shehata Dawood

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Ahmed Elhalwagy, MD

  Tanta Universit

  STUDY DIRECTOR

• 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 CHAIR

Central Study Contacts

Ayman Dawood, MD

CONTACT

+201020972067; ayman.dawood@med.tanta.edu.eg

Adel Elgergawy, MD

CONTACT

+201002057250; dradelali775@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months

Locations

EG (1)