Ectopic PregnancyNCT06165770
Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes
An observational study of Ectopic Pregnancy, run by University of Palermo.
Trial summary
To present our experience in the diagnosis and management of cornual pregnancy. A systematic review was also conducted to investigate reproductive outcomes after treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jan 2024
- 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 18 to 50 years
- Women only
- Adult
Study population: Patients with a diagnosis of Cornual pregnancy aged ≥ 18.
Who may be able to join
- age ≥18 years;
- patients with a diagnosis of cornual pregnancies.
Who cannot join
- All patients whose medical records did not contain the data deemed necessary for study analysis or who did not consent to the publication and use of their data;
- Other type of ectopic pregnancies.
About this study
To present our experience in the diagnosis and management of cornual pregnancy. A systematic review was also conducted to investigate reproductive outcomes after treatment.
- Conditions
- Ectopic Pregnancy
- Being tested
- laparoscopy
- Keywords
- cornual pregnancy, ectopic pregnancy, laparoscopy, methotrexate, fertility
- Medical subject headings
- Pregnancy, Ectopic, Pregnancy, Cornual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyProcedure or surgery
Conservative or surgery treatment for cornual pregnancies
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
defined as the presence of a gestational sac on transvaginal ultrasound or other definitive clinical signs
Measured: 2 years
ongoing pregnancy rate
defined as a pregnancy beyond 24 weeks of gestation
Measured: 2 years
miscarriage rate
defined as fetal loss before the 20th week of gestation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Etrusco, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165770
- Sponsor's protocol ID
- CORNUAL_pregnancies
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes
- ClinicalTrials.gov ID
- NCT06165770
- Acronym / sponsor ID
- CORNUAL_pregnancies
- Conditions
- Ectopic Pregnancy
- Keywords
- cornual pregnancy, ectopic pregnancy, laparoscopy, methotrexate, fertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 11 Dec 2023 (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.
To present our experience in the diagnosis and management of cornual pregnancy. A systematic review was also conducted to investigate reproductive outcomes after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients with a diagnosis of Cornual pregnancy aged ≥ 18.
Key inclusion criteria (2 listed)
- age ≥18 years;
- patients with a diagnosis of cornual pregnancies.
Key exclusion criteria (2 listed)
- All patients whose medical records did not contain the data deemed necessary for study analysis or who did not consent to the publication and use of their data;
- Other type of ectopic pregnancies.
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 |
|---|---|---|
| laparoscopyConservative or surgery treatment for cornual pregnancies | Procedure or surgery | – |
Primary outcome
clinical pregnancy rate
Time frame: 2 years
defined as the presence of a gestational sac on transvaginal ultrasound or other definitive clinical signs
ongoing pregnancy rate
Time frame: 2 years
defined as a pregnancy beyond 24 weeks of gestation
miscarriage rate
Time frame: 2 years
defined as fetal loss before the 20th week of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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, run by University of Palermo.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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?
Results are not available in the source record.
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?
clinical pregnancy rate (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.