NCT04778319

Brief Summary

unexplained infertility is a rising problem in clinical practice

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

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

February 27, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 27, 2021

Last Update Submit

February 27, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • the number of women who will become pregnant

    number of women who will have positive pregnancy test

    3 months

Study Arms (2)

tubal occlusion

ACTIVE COMPARATOR

occlusion of tubes

Other: occlusion of tubes

non occlusion of tube

SHAM COMPARATOR

non occlusion of tubes

Other: non occlusion of tubes

Interventions

occlusion of tubesOTHER

to occlude the fallopian tubes

tubal occlusion
non occlusion of tubesOTHER

not to occlude the tubes

non occlusion of tube

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with infertility
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with infertility

You may not qualify if:

  • women with medical disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aljazeera( Al Gazeera) hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mahmoud Alalfy

    Algezeera hospitaland National Research Centre ,Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 3, 2021

Study Start

March 2, 2021

Primary Completion

February 1, 2022

Study Completion

February 15, 2022

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

EG(1)