Clinical trial NCT05322278: Obstetric Outcomes After Double Embryo Transfer
Official title: Obstetric Outcomes After Double Embryo Transfer in Intracytoplasmic Sperm Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Double-Embryo Transfer in ICSI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 927
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women have ICSI at IVF unit at AUH

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

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.

Eligibility criteria: Inclusion Criteria:

* all patients subjected with ICSI pregnancy

Exclusion Criteria:

* incomplete data

Primary outcomes:
measure: Live birth
timeFrame: 1 year
Secondary outcomes:
measure: Rate of miscarriage
timeFrame: 1 year
measure: Rate of neonatal morbidities and mortalities in single embryo transfer versus double embryo transfer
timeFrame: 1 year
measure: Rate of admission to NICU
timeFrame: 1 year
measure: Rate of multiple pregnancies
timeFrame: 1 year
measure: Rate of preterm
timeFrame: 1 year
measure: Rate of PPROM
timeFrame: 1 year
measure: Rate of Clinical pregnancy
timeFrame: 1 year
measure: Rate of chemical pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Sherif Mohamed Abd Elmageed Badran, Lecturer
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.