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Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients

Primary Purpose

Infertility, Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic tubal disconnection
Laparoscopic salpingectomy
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Infertile ( primary or secondary ). Age > 30 years . HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically. Scheduled for IVF/ICSI Exclusion Criteria: Contraindications for laparoscopy Cardiac disease. BMI > 40 kg/m² Previous midline incision . Past history of TB peritonitis . Proximal tubal block by HCG . Frozen pelvis proved by previous laparoscopy or laparotomy . Allergy to contrast media of HSG . Premature ovarian failure (Serum FSH >40 mIU/ml ) Prescence of Male factor contributing to the infertility proved by abnormal semen analysis Prescence of Ovarian factor contributing to the infertility proved by the prescence of features suggesting anovulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tubal disconnection

    Salpingectomy

    Arm Description

    The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow Then, the tube is severed in the middle of the burn area with laparoscopic scissors Ensure adequate hemostasis

    The tube will be removed from its anatomical attachements by progressive bipolar coagulation Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors Removal of the tube through one of the ancillary ports using artery forceps Ensure adequate hemostasis

    Outcomes

    Primary Outcome Measures

    Ongoing pregnancy rate
    Pregnancy with detectable heart beat 10weeks gestation or beyond

    Secondary Outcome Measures

    Operative time
    in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
    Intraoperative complications
    Bowel injury - Vascular injury
    Postoperative complications
    ileus - surgical emphysema

    Full Information

    First Posted
    August 23, 2023
    Last Updated
    August 23, 2023
    Sponsor
    Ain Shams Maternity Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06015698
    Brief Title
    Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients
    Official Title
    Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams Maternity Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Tubal factor infertility is known to be one of the most common indications for IVF treatment. Patients with hydrosalpinges have been identified to have poor pregnancy outcomes such as lower implantation and pregnancy rates & higher rates of spontaneous abortion and ectopic pregnancies. Surgical intervention can be recommended for patients with hydrosalpinx prior to IVF/ICSI. This study will be done at Ain Shams University Maternity Hospital, to compare laparoscopic salpingectomy & laparoscopic tubal disconnection as two surgical modalities of treatment of unilateral or bilateral hydrosalpinges in women older than 30 years and scheduled for IVF/ICSI, regarding implantation rates, clinical pregnancy rates, ongoing pregnancy rates, ectopic pregnancy rates, and operative complications.
    Detailed Description
    It is estimated that tubal factors account for 14% of the causes of subfertility in women. The prevalence of hydrosalpinx among tubal diseases is as high as 30% of couples presenting with infertility from tubal factors. Hydrosalpinx is the dilation of the fallopian tube in the presence of distal tubal occlusion, which may result from several causes. The leading cause of distal tubal occlusion is pelvic inflammatory disease (PID), usually resulting from a prior sexually transmitted disease, such as Chlamydia trachomatis or Neisseria gonorrhoeae. Tubal tuberculosis is an uncommon cause of hydrosalpinx, though re-emerging in developed countries. Other etiologies include endometriosis, appendicitis, and abdominopelvic surgery. Depending on several patient factors, tubal microsurgery, or more commonly IVF with its improving success rates, are the recommended treatment options for tubal factor infertility. In addition to its essential role in infertility, hydrosalpinx has an adverse effect on the outcome of in vitro fertilization (IVF) Hydrosalpinx can decrease the clinical pregnancy rate of IVF-ET, and increase the incidence of abortion and ectopic pregnancy. The presence of hydrosalpinx has a negative effect on IVF/ET because of the suspected embryotoxicity of the hydrosalpingeal fluid due to a combination of mechanical and chemical factors thought to disrupt the endometrial environment. Surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment (Johnson et al .,2004 ) Removing (salpingectomy) or occluding blocked or diseased fallopian tubes before IVF can increase pregnancy and live birth rates for women on the IVF program. A network meta-analysis showed that Proximal tubal occlusion, salpingectomy, and aspiration for treatment of hydrosalpinx scored consistently better than did no intervention for the outcome of IVF/ET. Tubal occlusion and salpingectomy also improve ongoing pregnancy rates. Proximal tubal occlusion ranks highest for most of the outcomes assessed, whereas no intervention scores consistently as the least effective strategy for all outcomes

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tubal disconnection
    Arm Type
    Experimental
    Arm Description
    The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow Then, the tube is severed in the middle of the burn area with laparoscopic scissors Ensure adequate hemostasis
    Arm Title
    Salpingectomy
    Arm Type
    Active Comparator
    Arm Description
    The tube will be removed from its anatomical attachements by progressive bipolar coagulation Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors Removal of the tube through one of the ancillary ports using artery forceps Ensure adequate hemostasis
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic tubal disconnection
    Intervention Description
    The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow Then, the tube is severed in the middle of the burn area with laparoscopic scissors Ensure adequate hemostasis
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic salpingectomy
    Intervention Description
    The tube will be removed from its anatomical attachements by progressive bipolar coagulation Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors Removal of the tube through one of the ancillary ports using artery forceps Ensure adequate hemostasis
    Primary Outcome Measure Information:
    Title
    Ongoing pregnancy rate
    Description
    Pregnancy with detectable heart beat 10weeks gestation or beyond
    Time Frame
    From 10 + 0 weeks of gestation
    Secondary Outcome Measure Information:
    Title
    Operative time
    Description
    in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
    Time Frame
    in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
    Title
    Intraoperative complications
    Description
    Bowel injury - Vascular injury
    Time Frame
    During the procedure
    Title
    Postoperative complications
    Description
    ileus - surgical emphysema
    Time Frame
    First 48 hours after the procedure

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infertile ( primary or secondary ). Age > 30 years . HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically. Scheduled for IVF/ICSI Exclusion Criteria: Contraindications for laparoscopy Cardiac disease. BMI > 40 kg/m² Previous midline incision . Past history of TB peritonitis . Proximal tubal block by HCG . Frozen pelvis proved by previous laparoscopy or laparotomy . Allergy to contrast media of HSG . Premature ovarian failure (Serum FSH >40 mIU/ml ) Prescence of Male factor contributing to the infertility proved by abnormal semen analysis Prescence of Ovarian factor contributing to the infertility proved by the prescence of features suggesting anovulation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed M Elmaraghy, M.D.,
    Phone
    01010370980
    Email
    amam85@outlook.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Sewidan, M.D.,
    Phone
    01223733849
    Email
    Ahmed.Sewidan@med.suezuni.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy B Alqenawy, M.D.,
    Organizational Affiliation
    Ain Shams university - Faculty of Medicine
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed G Abd Elrahim, M.D.,
    Organizational Affiliation
    Ain Shams university - Faculty of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Alaa S Elsewafy, M.D.,
    Organizational Affiliation
    Ain Shams university - Faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12078836
    Citation
    Ajonuma LC, Ng EH, Chan HC. New insights into the mechanisms underlying hydrosalpinx fluid formation and its adverse effect on IVF outcome. Hum Reprod Update. 2002 May-Jun;8(3):255-64. doi: 10.1093/humupd/8.3.255.
    Results Reference
    background
    PubMed Identifier
    25436898
    Citation
    D'Arpe S, Franceschetti S, Caccetta J, Pietrangeli D, Muzii L, Panici PB. Management of hydrosalpinx before IVF: a literature review. J Obstet Gynaecol. 2015;35(6):547-50. doi: 10.3109/01443615.2014.985768. Epub 2014 Dec 1.
    Results Reference
    background
    PubMed Identifier
    27209341
    Citation
    Dreyer K, Lier MC, Emanuel MH, Twisk JW, Mol BW, Schats R, Hompes PG, Mijatovic V. Hysteroscopic proximal tubal occlusion versus laparoscopic salpingectomy as a treatment for hydrosalpinges prior to IVF or ICSI: an RCT. Hum Reprod. 2016 Sep;31(9):2005-16. doi: 10.1093/humrep/dew050. Epub 2016 May 21.
    Results Reference
    background
    PubMed Identifier
    23182560
    Citation
    Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006.
    Results Reference
    background
    PubMed Identifier
    30508891
    Citation
    Hong X, Ding WB, Yuan RF, Ding JY, Jin J. Effect of interventional embolization treatment for hydrosalpinx on the outcome of in vitro fertilization and embryo transfer. Medicine (Baltimore). 2018 Nov;97(48):e13143. doi: 10.1097/MD.0000000000013143.
    Results Reference
    background
    PubMed Identifier
    20091531
    Citation
    Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.
    Results Reference
    background
    PubMed Identifier
    9531862
    Citation
    Nackley AC, Muasher SJ. The significance of hydrosalpinx in in vitro fertilization. Fertil Steril. 1998 Mar;69(3):373-84. doi: 10.1016/s0015-0282(97)00484-6.
    Results Reference
    background
    PubMed Identifier
    25340218
    Citation
    National Collaborating Centre for Women's and Children's Health (UK). Fertility: Assessment and Treatment for People with Fertility Problems. London: Royal College of Obstetricians & Gynaecologists; 2013 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK247932/
    Results Reference
    background
    PubMed Identifier
    30824209
    Citation
    Ng KYB, Cheong Y. Hydrosalpinx - Salpingostomy, salpingectomy or tubal occlusion. Best Pract Res Clin Obstet Gynaecol. 2019 Aug;59:41-47. doi: 10.1016/j.bpobgyn.2019.01.011. Epub 2019 Jan 29.
    Results Reference
    background
    PubMed Identifier
    10972525
    Citation
    Strandell A. The influence of hydrosalpinx on IVF and embryo transfer: a review. Hum Reprod Update. 2000 Jul-Aug;6(4):387-95. doi: 10.1093/humupd/6.4.387.
    Results Reference
    background
    PubMed Identifier
    26922863
    Citation
    Tsiami A, Chaimani A, Mavridis D, Siskou M, Assimakopoulos E, Sotiriadis A. Surgical treatment for hydrosalpinx prior to in-vitro fertilization embryo transfer: a network meta-analysis. Ultrasound Obstet Gynecol. 2016 Oct;48(4):434-445. doi: 10.1002/uog.15900. Epub 2016 Sep 13.
    Results Reference
    background

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    Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients

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