NCT04335864

Brief Summary

Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

March 29, 2020

Last Update Submit

June 27, 2021

Conditions

Hydrosalpinx

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate following ICSI

    Defined as positive qualitative bhcg(beta human chorionic gonadotropin)

    14 days after Embryo transfer

Secondary Outcomes (1)

  • Ongoing pregnancy following ICSI

    8 weeks after Embryo transfer

Study Arms (2)

Group A

ACTIVE COMPARATOR

39 patients with hydrosalpinx will have laparoscopic salpingectomy

Procedure: Laparoscopic salpingectomy

Group B

ACTIVE COMPARATOR

39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion

Procedure: Hystroscopic proximal tubal occlusion

Interventions

Laparoscopic salpingectomyPROCEDURE

39 patients with hydrosalpinx will have laparoscopic salpingectomy

Group A
Hystroscopic proximal tubal occlusionPROCEDURE

39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion

Group B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary or secondary infertility cases
  • unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .

You may not qualify if:

  • Uterine factor of infertility
  • male factor of infertility
  • preexisting ovarian pathology
  • Presence of septic focus
  • medical or surgical conditions that contraindicated pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy hospital-cairo University

Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Lecturer in obstetrics and gyneocolgy department, Cairo university

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 6, 2020

Study Start

April 1, 2020

Primary Completion

October 30, 2020

Study Completion

December 15, 2020

Last Updated

June 29, 2021

Record last verified: 2021-06

Locations

EG(1)