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

Infertility Clinical Trial

— PCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913208
• Other study ID #: PCS
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Tanta University
• Contact: Ayman Dawood, MD
• Phone: +201020972067
• Email: ayman.dawood[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryopreservation
• ICSI
• Infertility
• IVF

Intervention

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.
• Fresh embryo transfer
usual strategy of giving the priority for fresh embryo transfer

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative pregnancy rates	The number of pregnant women in both groups after 3 cycles	3 months
Secondary	Failure of pregnancy	Failed ICSI	3 months