NCT03174873

Brief Summary

Ray and colleagues define "unexplained infertility" as failure to achieve pregnancy when the semen analysis is normal, evidence for ovulation is present, and tubal patency has been established. The efficacy of treatment declines with increasing age and duration of infertility Infertility is a disease , defined by the failure to achieve a successful pregnancy after 12 months or more of appropriate, timed unprotected intercourse or therapeutic donor insemination, barber evaluation and treatment may be justified based on medical history and physical findings and is warranted after 6 months for women over age 35 years. In unexplained infertility abnormalities are likely to be present but not detected by current methods including semen analysis in the man, assessment of the state of ovulation, ovulation reserve and patency of uterine tubes in the woman. unexplained infertility is not a rare item of infertility. Approximately 15% of infertility couple will be diagnosed with unexplained infertility after their diagnostic workup Many researches studied the laparoscopic tubal factor like tubo-ovarian relation, tubal kinks and fimbrial pathology. But we need to scope on more tubal factors like fatty mesosalpinx , fimbria ovarica, methylene blue free spill and others

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 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

Study Start

First participant enrolled

May 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

4.9 years

First QC Date

May 29, 2017

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy

    6 months

Study Arms (1)

Laparoscopy for unexplained infertile couples

OTHER
Procedure: laparoscopy

Interventions

laparoscopyPROCEDURE

Laparoscopy will be done for unexplained infertile couples before starting IVF because not all pathologic lesions that discovered by laparoscope need IVF and so, protect patients from unneeded IVF program

Laparoscopy for unexplained infertile couples

Eligibility Criteria

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

You may qualify if:

  • women with unexplained infertility.
  • women in reproductive period between 20 and 35 years.
  • primary or secondary infertility

You may not qualify if:

  • with age less than 20 years and more than 35 years old
  • other causes of infertility other than tubal factor
  • Other contraindications for laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 5, 2017

Study Start

May 1, 2017

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations