NCT06015698

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2023

Last Update Submit

August 23, 2023

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Pregnancy with detectable heart beat 10weeks gestation or beyond

    From 10 + 0 weeks of gestation

Secondary Outcomes (3)

  • Operative time

    in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity

  • Intraoperative complications

    During the procedure

  • Postoperative complications

    First 48 hours after the procedure

Study Arms (2)

Tubal disconnection

EXPERIMENTAL

1. 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 2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently 3. 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 4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors 5. Ensure adequate hemostasis

Procedure: Laparoscopic tubal disconnection

Salpingectomy

ACTIVE COMPARATOR

1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation 2. 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 3. Removal of the tube through one of the ancillary ports using artery forceps 4. Ensure adequate hemostasis

Procedure: Laparoscopic salpingectomy

Interventions

Laparoscopic tubal disconnectionPROCEDURE

1. 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 2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently 3. 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 4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors 5. Ensure adequate hemostasis

Tubal disconnection
Laparoscopic salpingectomyPROCEDURE

1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation 2. 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 3. Removal of the tube through one of the ancillary ports using artery forceps 4. Ensure adequate hemostasis

Salpingectomy

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile ( primary or secondary ).
  • Age \> 30 years .
  • HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically.
  • Scheduled for IVF/ICSI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 12078836BACKGROUND

  • 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.

    PMID: 25436898BACKGROUND

  • 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.

    PMID: 27209341BACKGROUND

  • 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.

    PMID: 23182560BACKGROUND

  • 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.

    PMID: 30508891BACKGROUND

  • 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.

    PMID: 20091531BACKGROUND

  • 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.

    PMID: 9531862BACKGROUND

  • 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/

    PMID: 25340218BACKGROUND

  • 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.

    PMID: 30824209BACKGROUND

  • 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.

    PMID: 10972525BACKGROUND

  • 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.

    PMID: 26922863BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Hamdy B Alqenawy, M.D.,

    Ain Shams university - Faculty of Medicine

    STUDY DIRECTOR

  • Ahmed G Abd Elrahim, M.D.,

    Ain Shams university - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Alaa S Elsewafy, M.D.,

    Ain Shams university - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Elmaraghy, M.D.,

CONTACT

01010370980amam85@outlook.com

Ahmed Sewidan, M.D.,

CONTACT

01223733849Ahmed.Sewidan@med.suezuni.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Obstetrics and Gynecology

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 29, 2023

Study Start

August 30, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

August 29, 2023

Record last verified: 2023-08