Pregnancy Rate After Unilateral Tubal Disconnection

November 23, 2023 updated by: Ayman S Dawood, MD, Tanta University

Pregnancy Rate After Laparoscopic Unilateral Tubal Disconnection

Unilateral disconnection of one tube that had hydrosalpinx

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx.

We either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 31111
        • Recruiting
        • Adel Elgergawy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • infertile women either primary or secondary Hydrosalpinx

Exclusion Criteria:

  • other factors of infertility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Unilateral tubal disconnection and waiting for pregnancy for 2 years after laparoscopy
Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancy
Unilateral tubal disconnection + Spontaneous follow up for pregnancy
Experimental: Control group
Unilateral tubal disconnection and ICSI
Procedure: Unilateral tubal disconnection + ICSI
Unilateral tubal disconnection + ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 2 years
Number of pregnant women after procedure
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRAUTD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When we finish the results

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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