NCT05322278

Brief Summary

Aim ; to compare obstetric outcomes in relation to number of embryo transfer in ICSI

Trial Health

87
On Track

Trial Health Score

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

Enrollment
927

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 12, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

December 12, 2021

Last Update Submit

June 7, 2024

Conditions

Double-Embryo Transfer in ICSI

Outcome Measures

Primary Outcomes (1)

  • Live birth

    Comparison

    1 year

Secondary Outcomes (8)

  • Rate of miscarriage

    1 year

  • Rate of neonatal morbidities and mortalities in single embryo transfer versus double embryo transfer

    1 year

  • Rate of admission to NICU

    1 year

  • Rate of multiple pregnancies

    1 year

  • Rate of preterm

    1 year

  • +3 more secondary outcomes

Study Arms (4)

Single Embryo Transfer

Single Embryo Transfer

Other: Data collection

Double embryo transfer

Other: Data collection

3 embryo transfer

Other: Data collection

4 embryo transfer

Other: Data collection

Interventions

Data collectionOTHER

No interventions

3 embryo transfer4 embryo transferDouble embryo transferSingle Embryo Transfer

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women have ICSI at IVF unit at AUH

You may qualify if:

  • all patients subjected with ICSI pregnancy

You may not qualify if:

  • incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • Clua E, Roca-Feliu M, Tresanchez M, Latre L, Rodriguez I, Martinez F, Barri PN, Veiga A. Single or double embryo transfer? Decision-making process in patients participating in an oocyte donation program. Gynecol Endocrinol. 2020 Apr;36(4):365-369. doi: 10.1080/09513590.2019.1653845. Epub 2019 Aug 29.

    PMID: 31464145BACKGROUND

  • Gremeau AS, Brugnon F, Bouraoui Z, Peikhrishvili R, Janny L, Pouly JL. [Outcome of elective single or double embryo transfer in first and second IVF/ICSI cycles]. Gynecol Obstet Fertil. 2011 Feb;39(2):70-5. doi: 10.1016/j.gyobfe.2010.08.005. French.

    PMID: 21316284BACKGROUND

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sherif Mohamed Abd Elmageed Badran, Lecturer

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of medicine, Assiut University, 71515 Assiut, Egypt

Study Record Dates

First Submitted

December 12, 2021

First Posted

April 11, 2022

Study Start

March 30, 2022

Primary Completion

November 1, 2023

Study Completion

March 1, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations

EG(1)