Ectopic PregnancyNCT06554964
Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy
A study testing performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube in people with Ectopic Pregnancy, run by Assaf-Harofeh Medical Center.
Trial summary
Ectopic pregnancy prevalence is approximately 1-2% of all pregnancies, majority of which located in the fallopian tube. Among the risk factors for ectopic pregnancy is tubal factor - meaning a mechanical problem within the fallopian tube resulting in the pregnancy remaining in the fallopian tube. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.
Who cannot join
- Patients with a history of unilateral salpingectomy
- Patients with suspected heterotopic pregnancy
- Patients with suspected allergic reaction to blue dye injection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility, Safety and Effectiveness of Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy
Ectopic pregnancy prevalence is approximately 1-2% of all pregnancies, majority of which located in the fallopian tube. Among the risk factors for ectopic pregnancy is tubal factor - meaning a mechanical problem within the fallopian tube resulting in the pregnancy remaining in the fallopian tube. The treatment o tubal pregnancy can be expectant, medical via metotrexate or surgicl via laparoscopic salpingectomy of the involved fallopian tube. The purpose of this study is to assess the feasibility of chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy hence assessing the function of the remaining fallopian tube and trying to predict future fertility for the patient.
Read the detailed description
Ectopic pregnancy occurs approximately in 1-2% of all pregnancies. The risk is higher among patients with risk factors such as previous ectopic pregnancy, history of pelvic inflammatory disease, endometriosis, past tubal surgery, pregnancy following in vitro fertilization, and pregnancy conceived with an intrauterine device. In 97% of the cases the location of the ectopic pregnancy would be in the fallopian tube. The management of fallopian tube ectopic pregnancy can be expectant, medical (with intramuscular methotrexate) or surgical via laparoscopic salpingectomy of the involved fallopian tube. The optimal management is chosen depending on the clinical presentation, sonographic and laboratory findings and patient's wishes.
Laparoscopic salpingectomy is indicated in cases of suspected ruptured ectopic pregnancy. Salpingectomy is also offered in cases of recurrent ipsilateral ectopic pregnancy, contraindications to medical management with methotrexate, and patients who prefer surgical over medical treatment.
The risk of recurrent ectopic tubal pregnancy following unilateral laparoscopic salpingectomy varies according to the functionality of the remaining fallopian tube and between different studies. In cases of an abnormal contralateral fallopian tube, the risk of recurrent tubal pregnancy is high. For patients with a healthy contralateral fallopian tube some studies found that the long-term fertility after salpingectomy was not significantly impacted, while other studies reported a mild reduction in natural conception rates. Thus, it is estimated that a functional remaining fallopian tube may capture oocytes from both ovaries, and may compensate for the loss of the other fallopian tube. Overall, the patency and functionality of the remaining fallopian tube is the most important factor in determining the risk of recurrent ectopic pregnancy and the rates of subsequent natural intrauterine conception.
Chromotubation is a procedure used in order to assess the patency of the fallopian tubes, mostly at time of laparoscopy under general anesthesia. It involves the injection of colored blue dye (mostly methylene blue or indigo carmine) through the cervix and into the uterine cavity and the fallopian tubes. During laparoscopy, the flow of the dye through the fallopian tubes may be observed, and the patency of the fallopian tubes may be determined.
The intracervical use of methylene blue or indigo-carmine for laparoscopic chromotubation is generally considered safe. Rare adverse reactions were described among patients with G6PD deficiency for whom methylene blue may cause hemolysis and for patient who are treated with SSRI for whom methylene blue may cause serotonin toxicity due to inhibition of monoamine oxidase.
Other methods to evaluate the patency of the fallopian tubes include hysterosalpingogram (HSG) and ultrasound guided perturbation using Exfoam. These imaging procedures are performed without anesthesia (and may be associated with pain and discomfort), and their results may be inconclusive because of tubal spasm. Thus laparoscopic chromotubation, which allows for the evaluation of tubal patency and pelvic anatomy, is considered the gold standard procedure.
The current practice in the management of patients undergoing laparoscopic salpingectomy for tubal pregnancy includes observation of the pelvic and tubal anatomy at time of surgery, followed by referral for outpatient assessment of tubal patency by HSG or by ultrasound at a later date, usually after ~2 months.
In the current study, the investigators propose to perform an evaluation of tubal patency by laparoscopic chromotubation at time of laparoscopic salpingectomy for tubal pregnancy. The investigators will assess the feasibility of the procedure (i.e., whether tubal patency may be determined in this setting), and its safety.
- Conditions
- Ectopic Pregnancy
- Being tested
- performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tubeProcedure or surgery
Performing chromotubation )injection of blue dye to the fallopian tube via cevical catheter) during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy. | Experimental | Patient undergoing laparoscopic salpingectomy due to ectopic tubal pregnancy will be offered chromotubation as the same tome in order to asess the potency of the remaining fallopian tube. Data will be recorded. Receives: Procedure: performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.
How many cases would demonstrate patent fallopian tube via blue dye injected verses how many occluded ones.
Measured: 1 year
Secondary outcomes (1)
Percentage of adverse reaction to chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.
How many allergic reactions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start30 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized cohort study including patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Neta Eisenberg Kogan, Assaf-Harofeh Medical Center
- Investigators
- Neta Eisenberg-Kogan, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554964
- Sponsor's protocol ID
- 0135-24-ASF
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: date will be shared and published once study is complected
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Effectiveness of Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy
- ClinicalTrials.gov ID
- NCT06554964
- Acronym / sponsor ID
- 0135-24-ASF
- Conditions
- Ectopic Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 15 Aug 2024 (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 prevalence is approximately 1-2% of all pregnancies, majority of which located in the fallopian tube. Among the risk factors for ectopic pregnancy is tubal factor - meaning a mechanical problem within the fallopian tube resulting in the pregnancy remaining in the fallopian tube. The treatment o tubal pregnancy can be expectant, medical via metotrexate or surgicl via laparoscopic salpingectomy of the involved fallopian tube. The purpose of this study is to assess the feasibility of chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy hence assessing the function of the remaining fallopian tube and trying to predict future fertility for the patient.
Detailed description
Ectopic pregnancy occurs approximately in 1-2% of all pregnancies. The risk is higher among patients with risk factors such as previous ectopic pregnancy, history of pelvic inflammatory disease, endometriosis, past tubal surgery, pregnancy following in vitro fertilization, and pregnancy conceived with an intrauterine device. In 97% of the cases the location of the ectopic pregnancy would be in the fallopian tube. The management of fallopian tube ectopic pregnancy can be expectant, medical (with intramuscular methotrexate) or surgical via laparoscopic salpingectomy of the involved fallopian tube. The optimal management is chosen depending on the clinical presentation, sonographic and laboratory findings and patient's wishes.
Laparoscopic salpingectomy is indicated in cases of suspected ruptured ectopic pregnancy. Salpingectomy is also offered in cases of recurrent ipsilateral ectopic pregnancy, contraindications to medical management with methotrexate, and patients who prefer surgical over medical treatment.
The risk of recurrent ectopic tubal pregnancy following unilateral laparoscopic salpingectomy varies according to the functionality of the remaining fallopian tube and between different studies. In cases of an abnormal contralateral fallopian tube, the risk of recurrent tubal pregnancy is high. For patients with a healthy contralateral fallopian tube some studies found that the long-term fertility after salpingectomy was not significantly impacted, while other studies reported a mild reduction in natural conception rates. Thus, it is estimated that a functional remaining fallopian tube may capture oocytes from both ovaries, and may compensate for the loss of the other fallopian tube. Overall, the patency and functionality of the remaining fallopian tube is the most important factor in determining the risk of recurrent ectopic pregnancy and the rates of subsequent natural intrauterine conception.
Chromotubation is a procedure used in order to assess the patency of the fallopian tubes, mostly at time of laparoscopy under general anesthesia. It involves the injection of colored blue dye (mostly methylene blue or indigo carmine) through the cervix and into the uterine cavity and the fallopian tubes. During laparoscopy, the flow of the dye through the fallopian tubes may be observed, and the patency of the fallopian tubes may be determined.
The intracervical use of methylene blue or indigo-carmine for laparoscopic chromotubation is generally considered safe. Rare adverse reactions were described among patients with G6PD deficiency for whom methylene blue may cause hemolysis and for patient who are treated with SSRI for whom methylene blue may cause serotonin toxicity due to inhibition of monoamine oxidase.
Other methods to evaluate the patency of the fallopian tubes include hysterosalpingogram (HSG) and ultrasound guided perturbation using Exfoam. These imaging procedures are performed without anesthesia (and may be associated with pain and discomfort), and their results may be inconclusive because of tubal spasm. Thus laparoscopic chromotubation, which allows for the evaluation of tubal patency and pelvic anatomy, is considered the gold standard procedure.
The current practice in the management of patients undergoing laparoscopic salpingectomy for tubal pregnancy includes observation of the pelvic and tubal anatomy at time of surgery, followed by referral for outpatient assessment of tubal patency by HSG or by ultrasound at a later date, usually after ~2 months.
In the current study, the investigators propose to perform an evaluation of tubal patency by laparoscopic chromotubation at time of laparoscopic salpingectomy for tubal pregnancy. The investigators will assess the feasibility of the procedure (i.e., whether tubal patency may be determined in this setting), and its safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized cohort study including patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy. | Experimental | Procedure: performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tubePatient undergoing laparoscopic salpingectomy due to ectopic tubal pregnancy will be offered chromotubation as the same tome in order to asess the potency of the remaining fallopian tube. Data will be recorded. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.
Key exclusion criteria (3 listed)
- Patients with a history of unilateral salpingectomy
- Patients with suspected heterotopic pregnancy
- Patients with suspected allergic reaction to blue dye injection
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 |
|---|---|---|
| performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tubePerforming chromotubation )injection of blue dye to the fallopian tube via cevical catheter) during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube | Procedure or surgery | Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy. |
Primary outcome
Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.
Time frame: 1 year
How many cases would demonstrate patent fallopian tube via blue dye injected verses how many occluded ones.
1 secondary outcome
Percentage of adverse reaction to chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Yes. date will be shared and published once study is complected
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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.
Neta Eisenberg-Kogan, MD principal investigator
Assaf-Harofeh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube in people with Ectopic Pregnancy, run by Assaf-Harofeh Medical Center.
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 3 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 8 Oct 2024. 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?
Contact Neta Eisenberg-Kogan, MD (+972542573878, netaeis3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy. (time frame: 1 year). 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 8 Oct 2024.