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Not yet recruitingNCT06554964Updated Oct 8, 2024

Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy

An interventional study of performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube in Ectopic Pregnancy, sponsored by Assaf-Harofeh Medical Center. Not yet recruiting. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Assaf-Harofeh Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Ectopic Pregnancy

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03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 267 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of unilateral salpingectomy
  2. Patients with suspected heterotopic pregnancy
  3. Patients with suspected allergic reaction to blue dye injection
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

    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.

    Procedure: performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube

Interventions

  • Procedureperforming chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — date will be shared and published once study is complected

Supporting information: Clinical study report

Time frame: date will be shared once study is complected for unlimited time

Access criteria: date will be shared in relevant publications

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06554964
Responsible party
Neta Eisenberg Kogan (Attending physician in the gynecology endoscopy unit, Assaf-Harofeh Medical Center) — Principal investigator
First posted
Aug 15, 2024
Start date
Sep 30, 2024 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Oct 8, 2024

Study contacts

Neta Eisenberg-Kogan, MD
Contact
netaeis3@gmail.com
+972542573878
Neta Eisenberg-Kogan, MD
principal investigator · Assaf-Harofeh Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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