NCT03824184

Brief Summary

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

January 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 2, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

5.3 years

First QC Date

January 28, 2019

Last Update Submit

September 23, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • the number of women who will get pregnant after IUI

    How many women will get pregnant after IUI

    within 4 weeks

Study Arms (2)

Hysteroscopic evaluation

ACTIVE COMPARATOR

Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline

Procedure: manipulation of endometrium

control group

OTHER

Hysteroscopic evaluation Control group : No infection

Procedure: manipulation of endometrium

Interventions

manipulation of endometriumPROCEDURE

Manipulation of endometrium with saline

Also known as: Saline infusion
Hysteroscopic evaluationcontrol group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with infertility age from 20-40 years

You may not qualify if:

  • Any factor of infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah and Kasralainy hospital

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mahmoud Alalfy

    Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Alalfy, PhD

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 31, 2019

Study Start

February 2, 2019

Primary Completion

May 3, 2024

Study Completion

June 20, 2024

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)