Tubal Factor in Unexplained Infertility
Primary Purpose
Infertility of Tubal Origin
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility of Tubal Origin
Eligibility Criteria
Inclusion Criteria:
- women with unexplained infertility.
- women in reproductive period between 20 and 35 years.
- primary or secondary infertility
Exclusion Criteria:
- with age less than 20 years and more than 35 years old
- other causes of infertility other than tubal factor
- Other contraindications for laparoscopy
Sites / Locations
- Women Health Hospital - Assiut universityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Laparoscopy for unexplained infertile couples
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174873
Brief Title
Tubal Factor in Unexplained Infertility
Official Title
Laparoscopic Tubal Evaluation in Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility of Tubal Origin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopy for unexplained infertile couples
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
laparoscopy
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with unexplained infertility.
women in reproductive period between 20 and 35 years.
primary or secondary infertility
Exclusion Criteria:
with age less than 20 years and more than 35 years old
other causes of infertility other than tubal factor
Other contraindications for laparoscopy
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed K ALi, MD
Phone
+201005537951
Email
m_khairy2001@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tubal Factor in Unexplained Infertility
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