Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
NCT ID: NCT06988774
Last Updated: 2025-06-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-06-02
Study Completion Date
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids.
Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction.
Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy.
This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.
Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction.
Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy.
This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy
NCT06554964
Ectopic Pregnancy
NOT_YET_RECRUITING
NA
Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes
NCT02703246
Fibroids
WITHDRAWN
NA
Hysteroscopic Evaluation of Fallopian Tubal Patency
NCT04077242
Infertility of Tubal Origin
Infertility, Female
Fallopian Tube Occlusion
+1 more
COMPLETED
NA
Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
NCT04392674
Gynecologic Surgery
UNKNOWN
NA
Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study
NCT06009562
Uterine Fibroid
Pregnancy Related
UNKNOWN
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background:
Fibroids have a prevalence \>75%, making it the most common benign uterine disease \[Zepiridis 2016, Lazaridis 2013, Giuliani 2020\]. Fibroids are well known to contribute to infertility and early pregnancy loss \[Don 2023, Pritts 2025, Carson 2021, Giuliani 2020\]. This is typically thought to be secondary to distortion and impairment of the endometrial cavity or myometrial junction. However, it has been stressed in recent reviews that the full mechanism of the effect of fibroids on infertility is not fully understood, and more studies are needed \[Donnez 2024\]. It is theorized but not well confirmed through evidence-based studies that fibroids may also occlude or compress fallopian tubes and contribute to tubal occlusion that may contribute to infertility \[Don 2023, Zepiridis 2016, Horne 2007, Somigliana 2021\]. Additionally, up to 25-35% of female-factor infertility is related to tubal disease \[ASRM Practice Committee 2021, Carson 2021, Mayrhofer 2022\]. There is very little data on tubal patency assessment in patients undergoing myomectomy. The investigators have been able to identify only one prospective study from 1993 that specifically evaluated fallopian tube filling during post-myomectomy hysterosalpingogram, though the primary outcome of this study was endometrial cavity architecture \[Lev-Toaff 1993\]. Two recent retrospective studies have demonstrated a significant association between presence of leiomyoma and tubal occlusion in women with infertility \[Mayrhofr 2024, Nako 2024\]. Nako et al (2024) found a significant association only with submucosal fibroids. The investigators have not identified any recent prospective studies evaluating tubal patency in patients with uterine leiomyoma or those undergoing myomectomy.
Most data regarding tubal patency assessment are collected on patients already diagnosed with infertility, which introduces the possibility of multiple confounding variables. There are no recent prospective studies of tubal occlusion in patients with fibroids or patients undergoing myomectomy.
Earlier detection of tubal disease may allow for a quicker and more proactive work up and counseling before other factors such as age and oocyte quality further impact fertility options. There is also limited data on tubal occlusion or patency in patients with fibroids and those undergoing myomectomy. Underappreciation of the effect of uterine fibroids and myomectomy on tubal patency and subsequent delays in diagnosis could further complicate fertility due to age, reduced ovarian reserve and oocyte quality. Knowledge of tubal occlusion may influence referral to an infertility specialist or counseling for ectopic pregnancy risk.
Objectives:
To evaluate the incidence of tubal occlusion in patients undergoing surgery for uterine fibroids before and after surgical intervention.
To assess the correlation between tubal patency and fibroid characteristics based on FIGO classification in patients undergoing surgery for uterine fibroids.
To assess characteristics of patients who have change in tubal occlusion.
This proposed study can help contribute to a more proactive approach to early detection and intervention for tubal occlusion in a high-risk patient population in order to achieve the following goals: to improve understanding of the effects of fibroids and myomectomy on tubal occlusion and to gain a better understanding in order to inform future studies to optimize counseling, diagnosis, and early intervention for tubal occlusive disease.
Design:
This is a single-arm prospective study using chromopertubation to assess tubal occlusion in patients undergoing minimally invasive gynecologic surgery for uterine fibroids. This procedure involves injecting a dilute solution of medical-grade dye into the endometrial cavity and visualizing spillage of the dye through the fallopian tubes into the abdominal cavity, indicating patency of the tubes that would allow for spontaneous conception. Chromopertubation will be performed at the initiation and completion of the surgery and tubal occlusion will be documented.
Chromopertubation procedure:
Pre-surgery: chromopertubation will be performed at the start of laparoscopic or robotic surgical procedure, once abdominal ports are in place and uterine manipulator placement has been performed prior to initiation of any myomectomy or other interventional surgical procedures.
Post-surgery: Chromopertubation will again be performed at the end of the surgery, once all surgical interventions are complete and prior to removal of abdominal ports and uterine manipulator.
Chromopertubation will be performed per standard clinical protocol as follows: Up to 50 mL of dilute methylene blue dye solution (1mL of 10 mg/mL 1% methylene blue in 200 mL normal saline) will be injected into the uterine cavity through a uterine manipulator with a patent central channel. This dose totals up to 2.5 mg of dilute methylene blue dye per chromopertubation injection and an anticipated maximum dose of 5 mg of dilute methylene blue per patient. Spillage of dye should be visible immediately after injection of dilute dye into the endometrial cavity if tubes are patent.
Adverse event monitoring:
As chromopertubation is an established medical procedure, patients will be monitored according to the standard intra-operative and post-operative criteria. If there are any signs of adverse events prior to completion of the study interventions, the study procedure will be aborted immediately and supportive therapy provided as needed. This will be done through communication between the surgical and anesthesiology teams.
Patients will be observed in the post-anesthesia care unit (PACU) according to standard postoperative protocol for any adverse events. In accordance with our standard post-operative practice, all patients will be discharged home upon meeting standard postoperative discharge criteria. As per routine standard protocol, all patients will be called at home to assess for any issues or concerns and to see how they are doing overall. This call is performed by either the attending surgeon or fellow on post-operative day #1, if discharged after surgery, or rounded on if admitted to the hospital overnight. Patients who report adverse effects once at home will be triaged and evaluated according to standard post-operative precautions.
There are no plans for long-term follow up at this time. Data will be collected intraoperatively and from chart review, including
* Pre-myomectomy tubal patency or occlusion - unilateral vs bilateral, proximal vs distal
* Post-myomectomy tubal patency or occlusion - unilateral vs bilateral, proximal vs distal
* Size, anatomic location and FIGO classification of fibroids removed
* Number of fibroids removed and total weight in grams
* Presence of endometriosis diagnosed intraoperatively
* Patient age, medical, surgical, obstetric, and gynecologic history
* Pre-operative imaging reports of the uterus/fibroids
Fibroids have a prevalence \>75%, making it the most common benign uterine disease \[Zepiridis 2016, Lazaridis 2013, Giuliani 2020\]. Fibroids are well known to contribute to infertility and early pregnancy loss \[Don 2023, Pritts 2025, Carson 2021, Giuliani 2020\]. This is typically thought to be secondary to distortion and impairment of the endometrial cavity or myometrial junction. However, it has been stressed in recent reviews that the full mechanism of the effect of fibroids on infertility is not fully understood, and more studies are needed \[Donnez 2024\]. It is theorized but not well confirmed through evidence-based studies that fibroids may also occlude or compress fallopian tubes and contribute to tubal occlusion that may contribute to infertility \[Don 2023, Zepiridis 2016, Horne 2007, Somigliana 2021\]. Additionally, up to 25-35% of female-factor infertility is related to tubal disease \[ASRM Practice Committee 2021, Carson 2021, Mayrhofer 2022\]. There is very little data on tubal patency assessment in patients undergoing myomectomy. The investigators have been able to identify only one prospective study from 1993 that specifically evaluated fallopian tube filling during post-myomectomy hysterosalpingogram, though the primary outcome of this study was endometrial cavity architecture \[Lev-Toaff 1993\]. Two recent retrospective studies have demonstrated a significant association between presence of leiomyoma and tubal occlusion in women with infertility \[Mayrhofr 2024, Nako 2024\]. Nako et al (2024) found a significant association only with submucosal fibroids. The investigators have not identified any recent prospective studies evaluating tubal patency in patients with uterine leiomyoma or those undergoing myomectomy.
Most data regarding tubal patency assessment are collected on patients already diagnosed with infertility, which introduces the possibility of multiple confounding variables. There are no recent prospective studies of tubal occlusion in patients with fibroids or patients undergoing myomectomy.
Earlier detection of tubal disease may allow for a quicker and more proactive work up and counseling before other factors such as age and oocyte quality further impact fertility options. There is also limited data on tubal occlusion or patency in patients with fibroids and those undergoing myomectomy. Underappreciation of the effect of uterine fibroids and myomectomy on tubal patency and subsequent delays in diagnosis could further complicate fertility due to age, reduced ovarian reserve and oocyte quality. Knowledge of tubal occlusion may influence referral to an infertility specialist or counseling for ectopic pregnancy risk.
Objectives:
To evaluate the incidence of tubal occlusion in patients undergoing surgery for uterine fibroids before and after surgical intervention.
To assess the correlation between tubal patency and fibroid characteristics based on FIGO classification in patients undergoing surgery for uterine fibroids.
To assess characteristics of patients who have change in tubal occlusion.
This proposed study can help contribute to a more proactive approach to early detection and intervention for tubal occlusion in a high-risk patient population in order to achieve the following goals: to improve understanding of the effects of fibroids and myomectomy on tubal occlusion and to gain a better understanding in order to inform future studies to optimize counseling, diagnosis, and early intervention for tubal occlusive disease.
Design:
This is a single-arm prospective study using chromopertubation to assess tubal occlusion in patients undergoing minimally invasive gynecologic surgery for uterine fibroids. This procedure involves injecting a dilute solution of medical-grade dye into the endometrial cavity and visualizing spillage of the dye through the fallopian tubes into the abdominal cavity, indicating patency of the tubes that would allow for spontaneous conception. Chromopertubation will be performed at the initiation and completion of the surgery and tubal occlusion will be documented.
Chromopertubation procedure:
Pre-surgery: chromopertubation will be performed at the start of laparoscopic or robotic surgical procedure, once abdominal ports are in place and uterine manipulator placement has been performed prior to initiation of any myomectomy or other interventional surgical procedures.
Post-surgery: Chromopertubation will again be performed at the end of the surgery, once all surgical interventions are complete and prior to removal of abdominal ports and uterine manipulator.
Chromopertubation will be performed per standard clinical protocol as follows: Up to 50 mL of dilute methylene blue dye solution (1mL of 10 mg/mL 1% methylene blue in 200 mL normal saline) will be injected into the uterine cavity through a uterine manipulator with a patent central channel. This dose totals up to 2.5 mg of dilute methylene blue dye per chromopertubation injection and an anticipated maximum dose of 5 mg of dilute methylene blue per patient. Spillage of dye should be visible immediately after injection of dilute dye into the endometrial cavity if tubes are patent.
Adverse event monitoring:
As chromopertubation is an established medical procedure, patients will be monitored according to the standard intra-operative and post-operative criteria. If there are any signs of adverse events prior to completion of the study interventions, the study procedure will be aborted immediately and supportive therapy provided as needed. This will be done through communication between the surgical and anesthesiology teams.
Patients will be observed in the post-anesthesia care unit (PACU) according to standard postoperative protocol for any adverse events. In accordance with our standard post-operative practice, all patients will be discharged home upon meeting standard postoperative discharge criteria. As per routine standard protocol, all patients will be called at home to assess for any issues or concerns and to see how they are doing overall. This call is performed by either the attending surgeon or fellow on post-operative day #1, if discharged after surgery, or rounded on if admitted to the hospital overnight. Patients who report adverse effects once at home will be triaged and evaluated according to standard post-operative precautions.
There are no plans for long-term follow up at this time. Data will be collected intraoperatively and from chart review, including
* Pre-myomectomy tubal patency or occlusion - unilateral vs bilateral, proximal vs distal
* Post-myomectomy tubal patency or occlusion - unilateral vs bilateral, proximal vs distal
* Size, anatomic location and FIGO classification of fibroids removed
* Number of fibroids removed and total weight in grams
* Presence of endometriosis diagnosed intraoperatively
* Patient age, medical, surgical, obstetric, and gynecologic history
* Pre-operative imaging reports of the uterus/fibroids
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Fallopian Tube Patency Tests
Fibroid/Myoma (Uterus/Cervix)
Myomectomy
Fallopian Tube Disease
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATOM study participants
Patients enrolled in the study who will undergo the chromopertubation per protocol
Group Type
EXPERIMENTAL
chromopertubation
Intervention Type
PROCEDURE
Pre- and post-myomectomy chromopertubation procedure using dilute methylene blue dye solution for evaluation of tubal occlusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
chromopertubation
Pre- and post-myomectomy chromopertubation procedure using dilute methylene blue dye solution for evaluation of tubal occlusion
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients undergoing minimally invasive laparoscopic or robotic-assisted uterine-preserving gynecologic surgery for removal of uterine fibroids (myomectomy) by a minimally invasive gynecologic surgeon at MedStar.
Exclusion Criteria
* Patients with both fallopian tubes absent
* Patients in whom it is not possible to place a uterine manipulator or catheter
* Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery
* Patients with allergy to methylene blue dye or G6PD deficiency
* Patients with positive pregnancy test on day of surgery
* Patients in whom it is not possible to place a uterine manipulator or catheter
* Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery
* Patients with allergy to methylene blue dye or G6PD deficiency
* Patients with positive pregnancy test on day of surgery
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medstar Health Research Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Barbieri RL. Farewell to indigo carmine. OBG Management. 2014. https://mdedge.com/obgmanagement/article/86698/pelvic-floor-dysfunction/farewell-indigo-carmine.
Reference Type
BACKGROUND
Zepiridis LI, Grimbizis GF, Tarlatzis BC. Infertility and uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:66-73. doi: 10.1016/j.bpobgyn.2015.12.001. Epub 2015 Dec 23.
Reference Type
BACKGROUND
Somigliana E, Reschini M, Bonanni V, Busnelli A, Li Piani L, Vercellini P. Fibroids and natural fertility: a systematic review and meta-analysis. Reprod Biomed Online. 2021 Jul;43(1):100-110. doi: 10.1016/j.rbmo.2021.03.013. Epub 2021 Mar 23.
Reference Type
BACKGROUND
Saunders RD, Shwayder JM, Nakajima ST. Current methods of tubal patency assessment. Fertil Steril. 2011 Jun;95(7):2171-9. doi: 10.1016/j.fertnstert.2011.02.054. Epub 2011 Mar 31.
Reference Type
BACKGROUND
Sankey-Thomas KM, Travieso J, Salazar CA, Williams-Brown M, Breen MT. Fertility sparing management of a large broad ligament fibroid. Journal of Minimally Invasive Gynecology. 2024;31(11, Supplement):S6.
Reference Type
BACKGROUND
Rzymski P, Wozniak J, Opala T, Wilczak M, Sajdak S. Anaphylactic reaction to methylene blue dye after laparoscopic chromopertubation. Int J Gynaecol Obstet. 2003 Apr;81(1):71-2. doi: 10.1016/s0020-7292(03)00036-5. No abstract available.
Reference Type
BACKGROUND
Ramin S, Azar FP, Malihe H. Methylene blue as the safest blue dye for sentinel node mapping: emphasis on anaphylaxis reaction. Acta Oncol. 2011 Jun;50(5):729-31. doi: 10.3109/0284186X.2011.562918. Epub 2011 Mar 17. No abstract available.
Reference Type
BACKGROUND
Pritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril. 2009 Apr;91(4):1215-23. doi: 10.1016/j.fertnstert.2008.01.051. Epub 2008 Mar 12.
Reference Type
BACKGROUND
Nako Y, Ota K, Sujino T, Mitsui J, Kamo H, Katsumata S, Takayanagi Y, Tajima M, Ishikawa T, Komiya A, Kawai K. A Large Study About Reproductive Factors That Predict Hysterosalpingography-Identified Tubal Pathology: An Insight into the Necessity of Preconception Screening. J Clin Med. 2024 Dec 31;14(1):179. doi: 10.3390/jcm14010179.
Reference Type
BACKGROUND
Mayrhofer D, Parry JP, Hager M, Beitl K, Kurz C, Ott J. Are the Stage and the Incidental Finding of Endometriosis Associated with Fallopian Tube Occlusion? A Retrospective Cohort Study on Laparoscopic Chromopertubation in Infertile Women. J Clin Med. 2022 Jun 28;11(13):3750. doi: 10.3390/jcm11133750.
Reference Type
BACKGROUND
Mayrhofer D, Holzer I, Aschauer J, Selzer C, Parry JP, Ott J. Incidence and Causes of Tubal Occlusion in Infertility: A Retrospective Cohort Study. J Clin Med. 2024 Jul 6;13(13):3961. doi: 10.3390/jcm13133961.
Reference Type
BACKGROUND
Lev-Toaff AS, Karasick S, Toaff ME. Hysterosalpingography before and after myomectomy: clinical value and imaging findings. AJR Am J Roentgenol. 1993 Apr;160(4):803-7. doi: 10.2214/ajr.160.4.8456668.
Reference Type
BACKGROUND
Lazaridis A, Hirsch M, Pistofidis G, Odejinmi F. Surgical management of uterine fibroids. Curr Opin Obstet Gynecol. 2023 Oct 1;35(5):440-445. doi: 10.1097/GCO.0000000000000903. Epub 2023 Aug 2.
Reference Type
BACKGROUND
Jena SK, Naik SS. Methemoglobinaemia after diagnostic hystero-laparoscopic chromopertubation in a sub-fertile patient. J Obstet Gynaecol. 2019 Oct;39(7):1025-1026. doi: 10.1080/01443615.2019.1581744. Epub 2019 Jun 9. No abstract available.
Reference Type
BACKGROUND
Horne AW, Critchley HO. The effect of uterine fibroids on embryo implantation. Semin Reprod Med. 2007 Nov;25(6):483-9. doi: 10.1055/s-2007-991046.
Reference Type
BACKGROUND
Giuliani E, As-Sanie S, Marsh EE. Epidemiology and management of uterine fibroids. Int J Gynaecol Obstet. 2020 Apr;149(1):3-9. doi: 10.1002/ijgo.13102. Epub 2020 Feb 17.
Reference Type
BACKGROUND
Egbe TO, Nana-Njamen T, Elong F, Tchounzou R, Simo AG, Nzeuga GP, Njamen Nana C, Manka'a E, Tchente Nguefack C, Halle-Ekane GE. Risk factors of tubal infertility in a tertiary hospital in a low-resource setting: a case-control study. Fertil Res Pract. 2020 Mar 6;6:3. doi: 10.1186/s40738-020-00073-4. eCollection 2020.
Reference Type
BACKGROUND
Donnez J, Taylor HS, Marcellin L, Dolmans MM. Uterine fibroid-related infertility: mechanisms and management. Fertil Steril. 2024 Jul;122(1):31-39. doi: 10.1016/j.fertnstert.2024.02.049. Epub 2024 Mar 5.
Reference Type
BACKGROUND
Don EE, Mijatovic V, Huirne JAF. Infertility in patients with uterine fibroids: a debate about the hypothetical mechanisms. Hum Reprod. 2023 Nov 2;38(11):2045-2054. doi: 10.1093/humrep/dead194.
Reference Type
BACKGROUND
Carson SA, Kallen AN. Diagnosis and Management of Infertility: A Review. JAMA. 2021 Jul 6;326(1):65-76. doi: 10.1001/jama.2021.4788.
Reference Type
BACKGROUND
Bezu C, Coutant C, Salengro A, Darai E, Rouzier R, Uzan S. Anaphylactic response to blue dye during sentinel lymph node biopsy. Surg Oncol. 2011 Mar;20(1):e55-9. doi: 10.1016/j.suronc.2010.10.002. Epub 2010 Nov 11.
Reference Type
BACKGROUND
Bagadia R, Kanabar V. Can laparoscopic chromopertubation with methylene blue dye cause anaphylactic reactions like pulmonary edema? WJOLS. 2017;10(2):51-53.
Reference Type
BACKGROUND
Practice Committee of the American Society for Reproductive Medicine. Electronic address: [email protected]. Role of tubal surgery in the era of assisted reproductive technology: a committee opinion. Fertil Steril. 2021 May;115(5):1143-1150. doi: 10.1016/j.fertnstert.2021.01.051. Epub 2021 Feb 26.
Reference Type
BACKGROUND
Ansari AH. Methylene blue test for assessment of tubal patency: a new and simple technique. Can Med Assoc J. 1968 Jul 27;99(4):182-4. No abstract available.
Reference Type
BACKGROUND
Akazawa M, Wu YH, Liu WM. Allergy-like reactions to methylene blue following laparoscopic chromopertubation: A systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2019 Jul;238:58-62. doi: 10.1016/j.ejogrb.2019.03.019. Epub 2019 Mar 20.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00008836
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
NCT01578759
COMPLETED
NA
A Retrospective Review Of Outcomes Following Laparoscopic Myomectomy
NCT00672750
TERMINATED
Prospective Analysis to Detect Myometrial Cells in Peritoneal Washing in Patients Undergoing Minimally Invasive Hysterectomy Using Containment Bag at University of Texas Medical Branch
NCT05955651
COMPLETED
Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
NCT02118974
COMPLETED
NA
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
NCT00910468
COMPLETED
Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.
NCT03570879
UNKNOWN
Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers?
NCT02563392
COMPLETED
NA
Pregnancy Outcomes Following Myomectomy
NCT06474065
COMPLETED
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
NCT06442605
NOT_YET_RECRUITING
NA
Clinical Evaluation of the Interlace Medical Hysteroscopic Morcellator
NCT01026805
COMPLETED
Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
NCT01581905
TERMINATED
NA
Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease
NCT06576362
NOT_YET_RECRUITING
NA
Intraoperative Ultrasound in Laparoscopic or Robotic Myomectomy Patients
NCT02879058
TERMINATED
NA
Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
NCT05374720
UNKNOWN
NA
HOME Study: Hysteroscopic Office Myomectomy Evaluation
NCT01152112
COMPLETED
NA
Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy
NCT05659303
COMPLETED
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
NCT00874029
COMPLETED
NA
Questionnaire Study to Assess Quality of Life After Treatment of Fibroids
NCT00390494
UNKNOWN
Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy
NCT01418807
COMPLETED
PHASE2/PHASE3
Efficacy of In-bag Morcellation
NCT03281460
COMPLETED
NA
Clinical Outcomes of Robotic Myomectomy
NCT06208891
RECRUITING
Total Laparoscopic Hysterectomy vs Minilap Hysterectomy
NCT03251677
COMPLETED
NA
The Benefits and Limits of Laparoscopic Surgery for Uterine Fibroids
NCT00860002
UNKNOWN
Hysteroscopic Assessment of Fallopian Tubal Patency
NCT02005263
COMPLETED
NA