Tubal Factor in Unexplained Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03174873
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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

Condition or disease Intervention/treatment Phase
Infertility of Tubal Origin Procedure: laparoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Laparoscopic Tubal Evaluation in Unexplained Infertility
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Laparoscopy for unexplained infertile couples Procedure: laparoscopy
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 Measures :
  1. Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03174873

Women Health Hospital - Assiut university Recruiting
Assiut, Egypt, 71111
Contact: Mohammed K ALi, MD    +201005537951   
Sponsors and Collaborators
Assiut University

Responsible Party: Mohammed Khairy Ali, Lecturer of obstetrics and gynecology, Assiut University Identifier: NCT03174873     History of Changes
Other Study ID Numbers: TFUI
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female