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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03174873
Other study ID # TFUI
Secondary ID
Status Recruiting
Phase N/A
First received May 29, 2017
Last updated May 31, 2017
Start date May 1, 2017
Est. completion date May 2019

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Egypt Women Health Hospital - Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy 6 months
See also
  Status Clinical Trial Phase
Completed NCT04077242 - Hysteroscopic Evaluation of Fallopian Tubal Patency N/A
Not yet recruiting NCT04945265 - Effects of Age and Infertility on Ovarian Granulosa Cell Function
Not yet recruiting NCT05775913 - Clinical Evaluation of a Tubal Selective Delivery System N/A
Completed NCT05209542 - Hysterosalpingo-Foam Ultrasonography Combined With Power Doppler, Compared With Laparoscopy in Tubal Patency Assessment in Cases of Infertility N/A