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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04736459
Other study ID # 2222392979
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 29, 2021
Est. completion date June 1, 2021

Study information

Verified date January 2021
Source Eskisehir Osmangazi University
Contact Vehbi Yavuz Tokgöz
Phone +902222392979
Email mdtokgoz@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes. We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - at least 1-year infertility - at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy - ovulatory menstrual cycles - suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination Exclusion Criteria: - bilateral tubal occlusion - mild or severe endometriosis - day 3 serum FSH (follicle-stimulating hormone) > 13 IU/L - abnormal thyroid function tests, hyperprolactinemia - total motile sperm count (TMSC) < 5 millions or severe teratospermia (<4% normal forms) following semen preparation - more than 3 follicles above the size of 17mm on the day of ovulation triggering

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination
The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks 8 weeks after intrauterine insemination
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