Clinical trial NCT06015698: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Contraindications for laparoscopy

   * Cardiac disease.
   * BMI \> 40 kg/m²
   * Previous midline incision .
   * Past history of TB peritonitis .
2. Proximal tubal block by HCG .
3. Frozen pelvis proved by previous laparoscopy or laparotomy .
4. Allergy to contrast media of HSG .
5. Premature ovarian failure (Serum FSH \>40 mIU/ml )
6. Prescence of Male factor contributing to the infertility proved by abnormal semen analysis
7. Prescence of Ovarian factor contributing to the infertility proved by the prescence of features suggesting anovulation

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: From 10 + 0 weeks of gestation
Secondary outcomes:
measure: Operative time
timeFrame: in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
measure: Intraoperative complications
timeFrame: During the procedure
measure: Postoperative complications
timeFrame: First 48 hours after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams university - Faculty of Medicine
name: Hamdy B Alqenawy, M.D.,
role: STUDY_DIRECTOR
affiliation: Ain Shams university - Faculty of Medicine
name: Ahmed G Abd Elrahim, M.D.,
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams university - Faculty of Medicine
name: Alaa S Elsewafy, M.D.,
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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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.
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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/
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.
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.
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.