Obstetric Outcomes After Double Embryo Transfer

Obstetric Outcomes After Double Embryo Transfer in Intracytoplasmic Sperm Injection

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

Study Overview

• Status: Completed
• Conditions: Double-Embryo Transfer in ICSI
• Intervention / Treatment: Other: Data collection

Detailed Description

Assisted reproductive technology with intracytoplasmic sperm injection (ICSI) and IVF is becoming an international direction for couples struggling with infertility. The increasing popularity and frequency of these techniques and the data generated from it has given us a better overview of the efficacy, consequences and costs of these techniques.

The aim of assisted reproductive technology (ART) is to achieve pregnancy while decreasing the risk of multiple gestations. When compared with elective single embryo transfer (SET), double embryo transfer (DET) demonstrates a superior pregnancy and live birth rate with a significantly higher risk of multiple gestations. The high frequency of multiple births is the main factor which leads to adverse outcome in IVF/intracytoplasmic sperm injection (ICSI) treatment. Transfer of two embryos does not diminish the chance of a birth when compared with three embryo transfer. How would be the obstetric outcome in pregnancies resulting from DET in IVF/ICSI cycles.

Despite achieving a higher pregnancy rates, DET in ART leads to an increase in multiple gestation pregnancies, which are associated with increased both maternal and neonatal morbidity and mortality.

Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies. Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies.

Most patients prefer to have two embryos transferred, due to financial considerations being the main reason.

Studies demonstrate that patients are more likely prefer to choose SET when educated about the risks of multiple gestation pregnancy, but select two embryos for transfer if they have a lower pregnancy rate when compared with transferring one embryo .

Cost effectiveness research comparing single versus DET after in vitro fertilization (IVF) has previously been performed, with most studies taking place in areas with mandated IVF insurance coverage, and few incorporating hospital costs linked to obstetrical and neonatal outcomes.

• Study Type: Observational
• Enrollment (Actual): 927

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All women have ICSI at IVF unit at AUH

Description

Inclusion Criteria:

• all patients subjected with ICSI pregnancy

Exclusion Criteria:

• incomplete data

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Embryo Transfer	Other: Data collection; No interventions
Double embryo transfer	Other: Data collection; No interventions
3 embryo transfer	Other: Data collection; No interventions
4 embryo transfer	Other: Data collection; No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth	Comparison	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of neonatal morbidities and mortalities in single embryo transfer versus double embryo transfer	Comparison	1 year
Rate of miscarriage	Comparison	1 year
Rate of admission to NICU	Comparison	1 year
Rate of multiple pregnancies	Comparison	1 year
Rate of preterm	Comparison	1 year
Rate of PPROM	Comparison	1 year
Rate of Clinical pregnancy	Comparison	1 year
Rate of chemical pregnancy	Comparison	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Sherif Mohamed Abd Elmageed Badran, Lecturer, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: April 3, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DET in ICSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No