Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients
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| ClinicalTrials.gov Identifier: NCT06015698 |
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Recruitment Status :
Not yet recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 23, 2023 | |||||||||
| First Posted Date ICMJE | August 29, 2023 | |||||||||
| Last Update Posted Date | August 29, 2023 | |||||||||
| Estimated Study Start Date ICMJE | August 30, 2023 | |||||||||
| Estimated Primary Completion Date | August 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Ongoing pregnancy rate [ Time Frame: From 10 + 0 weeks of gestation ] Pregnancy with detectable heart beat 10weeks gestation or beyond
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients | |||||||||
| Official Title ICMJE | Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial | |||||||||
| 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. |
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| 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 |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Infertility, Female | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Not yet recruiting | |||||||||
| Estimated Enrollment ICMJE |
150 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | August 30, 2024 | |||||||||
| Estimated Primary Completion Date | August 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 30 Years to 40 Years (Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT06015698 | |||||||||
| Other Study ID Numbers ICMJE | 10 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Ain Shams Maternity Hospital | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Ain Shams Maternity Hospital | |||||||||
| Verification Date | August 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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