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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ectopic Pregnancy; Assisted Reproductive Technology

Intervention / Treatment
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* Procedure: I and II level ART procedure


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectopic pregnancy population<br>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. | Procedure: I and II level ART procedure<br>* I level: Intrauterine insemination II level: Invitro fertilization technique; Intracytoplasmic sperm injection; Embryo transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EP's incidence | measurement of incidences of EPs in Intrauterine insemination, in vitro fertilization, intracytoplasmic injection and embryo transfer. | 10 years | 
| comparison of EP's incidence with present risk factors | 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. | 10 years |