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

Ectopic Pregnancy; Assisted Reproductive Technology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325854
• Other study ID #: xxx/2020
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27377
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ectopic Pregnancy; Assisted Reproductive Technology
• Pregnancy, Ectopic

Intervention

Procedure:
• I and II level ART procedure
I level: Intrauterine insemination II level: Invitro fertilization technique; Intracytoplasmic sperm injection; Embryo transfer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EP's incidence	measurement of incidences of EPs in Intrauterine insemination, in vitro fertilization, intracytoplasmic injection and embryo transfer.	10 years
Primary	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