NCT04485910

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

July 22, 2020

Last Update Submit

July 22, 2020

Conditions

InfertilityAneuploidy RateMosaicism

Keywords

PGT-AMosaicismSingle step mediaSequential media

Outcome Measures

Primary Outcomes (2)

  • Euploidy rate

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

    5:7 days of intracytoplasmic sperm injection(ICSI)

  • Mosaicism rate

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

    5:7 days of ICSI

Secondary Outcomes (5)

  • Fertilization rate

    16:19 hours of ICSI

  • Cleavage stage

    72 hours of ICSI

  • High quality of cleaved embryos

    72 hours of ICSI

  • Blast formation rate

    5:7 days of ICSI

  • High quality blast rate

    5:7 days of ICSI

Study Arms (2)

Single step media

ACTIVE COMPARATOR

Embryos cultured in single step media

Other: Single step media

Sequential media

ACTIVE COMPARATOR

Embryos cultured in sequential media

Other: Sequential media

Interventions

Single step mediaOTHER

Usage of single step media in embryo culture

Single step media
Sequential mediaOTHER

Usage of sequential media in embryo culture

Sequential media

Eligibility Criteria

Age18 Years - 37 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale age ≤37 years with ≥ 8 mature oocytes
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • sperm or oocyte donor
  • severe male factors according to WHO 2010

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganin Fertility Center

Cairo, 11728, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Manar M Hozyen, MSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Amr Elshimy, BSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hanaa Elkhader, BSc.

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

  • Hosam Zaki, MSc.

    Ganin Fertility Center

    STUDY CHAIR

Central Study Contacts

Manar M Hozyen, MSc.

CONTACT

+201229483320manarnrc@gmail.com

Amr Elshimy, BSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

December 1, 2019

Primary Completion

March 1, 2021

Study Completion

June 1, 2021

Last Updated

July 24, 2020

Record last verified: 2020-06

Locations

EG(1)