PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

• Sponsor: Ganin Fertility Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04485910
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

A prospective cohort study undergoing ICSI at a private fertility center in Egypt

Condition or Disease	Intervention/Treatment	Phase
Infertility; Aneuploidy Rate; Mosaicism	Other: Single step media; Other: Sequential media	N/A

Detailed Description

Purpose:

To evaluate PGTai results for embryos cultured in sequential versus single step media.

Method:

Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).

All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program
• Actual Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single step media Embryos cultured in single step media	Other: Single step media; Usage of single step media in embryo culture
Active Comparator: Sequential media Embryos cultured in sequential media	Other: Sequential media; Usage of sequential media in embryo culture

Outcome Measures

Primary Outcome Measures

1. Euploidy rate [5:7 days of intracytoplasmic sperm injection(ICSI)]

   percentage of euploid embryos/ total genetic tested embryos on blast stage

2. Mosaicism rate [5:7 days of ICSI]

   percentage of mosaic embryos/ total genetic tested embryos on blast stage

Secondary Outcome Measures

1. Fertilization rate [16:19 hours of ICSI]

   Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes

2. Cleavage stage [72 hours of ICSI]

   Percentage of cleaved embryos/ total number of fertilized oocytes

3. High quality of cleaved embryos [72 hours of ICSI]

   High quality D3 embryos according to Gardner's criteria / total cleaved embryos

4. Blast formation rate [5:7 days of ICSI]

   Percentage of total blastocysts / Total cleaved embryos

5. High quality blast rate [5:7 days of ICSI]

   Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 37 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female age ≤37 years with ≥ 8 mature oocytes

• Male partner had normal semen parameters according to WHO 2010

• PGT-A was done at the blastocyst stage

Exclusion Criteria:

• sperm or oocyte donor

• severe male factors according to WHO 2010

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ganin Fertility Center	Cairo		Egypt	11728

Sponsors and Collaborators

• Ganin Fertility Center

Investigators

• Principal Investigator: Manar M Hozyen, MSc., Ganin Fertility Center
• Principal Investigator: Amr Elshimy, BSc., Ganin Fertility Center
• Principal Investigator: Hanaa Elkhader, BSc., Ganin Fertility Center
• Study Chair: Hosam Zaki, MSc., Ganin Fertility Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ganin Fertility Center
• ClinicalTrials.gov Identifier: NCT04485910
• Other Study ID Numbers: MH0004
• First Posted: Jul 24, 2020
• Last Update Posted: Jul 24, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ganin Fertility Center: PGT-A; Mosaicism; Single step media; Sequential media
• Additional relevant MeSH terms: Infertility; Aneuploidy

Study Results

No Results Posted as of Jul 24, 2020