NCT04389203

Brief Summary

Unilateral disconnection of one tube that had hydrosalpinx

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

May 12, 2020

Last Update Submit

November 23, 2023

Conditions

Pregnancy Rate

Keywords

pregnancy rateLasparosocpyUnilateral tubal disconnectionIntracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Number of pregnant women after procedure

    2 years

Study Arms (2)

Study group

EXPERIMENTAL

Unilateral tubal disconnection and waiting for pregnancy for 2 years after laparoscopy

Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancy

Control group

EXPERIMENTAL

Unilateral tubal disconnection and ICSI

Procedure: Unilateral tubal disconnection + ICSI

Interventions

Unilateral tubal disconnection + Spontaneous follow up for pregnancyPROCEDURE

Unilateral tubal disconnection + Spontaneous follow up for pregnancy

Study group
Unilateral tubal disconnection + ICSIPROCEDURE

Unilateral tubal disconnection + ICSI

Control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertile women either primary or secondary Hydrosalpinx

You may not qualify if:

  • other factors of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adel Elgergawy

Tanta, Gharbia Governorate, 31111, Egypt

RECRUITING

MeSH Terms

Interventions

PregnancySperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaFertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Unilateral tubal disconnection and spontaneous pregnancy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 15, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

When we finish the results

Shared Documents
STUDY PROTOCOL
Time Frame
6 months

Locations

EG(1)