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

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ClinicalTrials.gov Identifier: NCT03913208
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

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.

Condition or disease Intervention/treatment Phase
Infertility IVF ICSI Cryopreservation Procedure: Priority to freeze Procedure: Fresh embryo transfer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles is it Going to Make the Difference?
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. Cumulative pregnancy rates [ Time Frame: 3 months ]
    The number of pregnant women in both groups after 3 cycles


Secondary Outcome Measures :
  1. Failure of pregnancy [ Time Frame: 3 months ]
    Failed ICSI



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913208


Contacts
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Contact: Ayman Dawood, MD +201020972067 ayman.dawood@med.tanta.edu.eg
Contact: Adel Elgergawy, MD +201002057250 dradelali775@gmail.com

Locations
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Egypt
Ayman Shehata Dawood Recruiting
Tanta, Egypt
Contact: Ahmed Elhalwagy         
Sponsors and Collaborators
Tanta University
Investigators
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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

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Responsible Party: Ayman S Dawood, MD, Lecturer, Tanta University
ClinicalTrials.gov Identifier: NCT03913208     History of Changes
Other Study ID Numbers: PCS
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will decide the type of data to share
Supporting Materials: Study Protocol
Time Frame: 3 months

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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
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female