Ectopic Pregnancy; Assisted Reproductive TechnologyNCT04325854
Risk Factors for Ectopic Pregnancy: Comparison of Fresh and Warmed Transfers. Analysis of a 10 Years, a Single Center Experience.
An observational study of Ectopic Pregnancy; Assisted Reproductive Technology, run by Istituto Clinico Humanitas.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ectopic Pregnancy; Assisted Reproductive Technology
- What is being tested?
- I and II level ART procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 27,377 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- Women with diagnosis of EP. Ectopic pregnancy diagnosis was performed with B-hcg measurement and imaging visualization of the gestational sac outside the uterus
Who cannot join
- No case was excluded
About this study
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
Read the 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.
- Being tested
- I and II level ART procedure
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I and II level ART procedureProcedure or surgery
I level: Intrauterine insemination II level: Invitro fertilization technique; Intracytoplasmic sperm injection; Embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Ectopic pregnancy population | 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. Receives: Procedure: I and II level ART procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
EP's incidence
measurement of incidences of EPs in Intrauterine insemination, in vitro fertilization, intracytoplasmic injection and embryo transfer.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ectopic Pregnancy; Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 27,377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325854
- Sponsor's protocol ID
- xxx/2020
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16507930Londra 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.
PubMed 25956363Muller 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.
PubMed 27759446
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Ectopic Pregnancy: Comparison of Fresh and Warmed Transfers. Analysis of a 10 Years, a Single Center Experience.
- ClinicalTrials.gov ID
- NCT04325854
- Acronym / sponsor ID
- xxx/2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,377 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ectopic pregnancy population | – | Procedure: I and II level ART procedureThe 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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women with diagnosis of EP. Ectopic pregnancy diagnosis was performed with B-hcg measurement and imaging visualization of the gestational sac outside the uterus
Key exclusion criteria (1 listed)
- No case was excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I and II level ART procedureI level: Intrauterine insemination II level: Invitro fertilization technique; Intracytoplasmic sperm injection; Embryo transfer | Procedure or surgery | Ectopic pregnancy population |
Primary outcome
EP's incidence
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 16507930Clayton 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.
- Background: PubMed 25956363Londra 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.
- Background: PubMed 27759446Muller 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy; Assisted Reproductive Technology, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EP's incidence (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04325854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.