Risk Factors for Ectopic Pregnancy: Comparison of Fresh and Warmed Transfers. Analysis of a 10 Years, a Single Center Experience.

Completed

• Conditions: Ectopic Pregnancy; Assisted Reproductive Technology
• Interventions: Procedure: I and II level ART procedure

• Registration Number: NCT04325854
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Ectopic pregnancy (EP) is a leading cause of maternal death during the first trimester of pregnancy. Previous studies have reported an increased incidence of EP in Assisted reproductive technologies techniques (ART) (Clayton et al., 2006), and in particular with fresh blastocyst embryo transfer compared with warmed embryo transfer (Londra et al., 2015). In consideration of the widespread use of ART techniques in gynaecology and the high morbidity and mortality associated with EP, providing further insight into the risk factors associated with EPs in ART appears of great relevance. The objective of this study is to compare the incidences of EPs in all ART procedures (both I and II level) in a single, third level ART center throughout a 10-year period. In addition, we also aim to revise recognized EP's risk factors among patients undergoing these procedure and to evaluate their impact in determining extrauterine implantation

Detailed Description

Ectopic pregnancy (EP) remain a leading cause of maternal death during the first trimester of pregnancy. Previous studies have reported an increased incidence of EP in Assisted reproductive technologies techniques (ART) (Clayton et al., 2006), and in particular with fresh blastocyst embryo transfer compared with warmed embryo transfer (Londra et al., 2015). However a metanalysis on the topic argued that the results of many studies vary significantly within years of publishing and center locations; therefore, an accurate management strategy for patients at risk of ectopic gestation after invitro fertilization and embryo transfer (IVF-ET) procedure has not been established(V. Muller et al., 2016). In addition literature on I level ART procedures appears to be lacking. In consideration of the widespread use of ART techniques in gynaecology and the high morbidity and mortality associated with EP, providing further insight into the risk factors associated with EPs in ART appears of great relevance. Indeed, revising EP risk factors may help in reducing EP incidence in ART through the stratification of women according to their characteristics and the employment of special measures.

The objective of this study is to compare the incidences of EPs in all ART procedures (both I and II level) in a single, third level ART center throughout a 10-year period. In addition, we also aim to revise recognized EP's risk factors among patients undergoing these procedure and to evaluate their impact in determining extrauterine implantation.

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27377

Inclusion Criteria

• Women with diagnosis of EP. Ectopic pregnancy diagnosis was performed with B-hcg measurement and imaging visualization of the gestational sac outside the uterus

Exclusion Criteria

• No case was excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ectopic pregnancy population	I and II level ART procedure	The data have been collected from the Humanitas Fertility Center' Department database (ART.it) from all ART procedures (both I and II level) performed between 2009 and 2018.

Primary Outcome Measures

Name	Time	Method
EP's incidence	10 years	measurement of incidences of EPs in Intrauterine insemination, in vitro fertilization, intracytoplasmic injection and embryo transfer.
comparison of EP's incidence with present risk factors	10 years	comparinson of EP's incidences according to the presence of recognized EP's risk factors such as advanced maternal age, tubal disease, BMI, smoking and PID., previous pelvic os abdominal surgeries, previous uterine surgeries, primary or secondary infertility.