Clinical trial NCT04325854: Risk Factors for Ectopic Pregnancy: Comparison of Fresh and Warmed Transfers. Analysis of a 10 Years, a Single Center Experience.
Official title: Risk Factors for Ectopic Pregnancy: Comparison of Fresh and Warmed Transfers. Analysis of a 10 Years, a Single Center Experience.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy; Assisted Reproductive Technology
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 27377
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We evaluated data from all women performing I level ART procedures (i.e Intrauterine insemination (IUI)) and II level ART procedures (i.e Invitro Fertilization (IVF) and Intracytoplasmic sperm injection (ICSI), Embryo transfer (ET)) from 2009 to 2018.

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.

Eligibility criteria: 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

Primary outcomes:
measure: EP's incidence
timeFrame: 10 years
measure: comparison of EP's incidence with present risk factors
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Clayton HB, Schieve LA, Peterson HB, Jamieson DJ, Reynolds MA, Wright VC. Ectopic pregnancy risk with assisted reproductive technology procedures. Obstet Gynecol. 2006 Mar;107(3):595-604. doi: 10.1097/01.AOG.0000196503.78126.62.
citation: Londra L, Moreau C, Strobino D, Garcia J, Zacur H, Zhao Y. Ectopic pregnancy after in vitro fertilization: differences between fresh and frozen-thawed cycles. Fertil Steril. 2015 Jul;104(1):110-8. doi: 10.1016/j.fertnstert.2015.04.009. Epub 2015 May 5.
citation: Muller V, Makhmadalieva M, Kogan I, Fedorova I, Lesik E, Komarova E, Dzhemlikhanova L, Niauri D, Gzgzyan A, Ailamazyan E. Ectopic pregnancy following in vitro fertilization: meta-analysis and single-center experience during 6 years. Gynecol Endocrinol. 2016 Oct;32(sup2):69-74. doi: 10.1080/09513590.2016.1232550.