Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination

Not Applicable

• Conditions: Infertility
• Interventions: Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination

• Registration Number: NCT04736459
• Lead Sponsor: Eskisehir Osmangazi University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-29
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-01-29
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unwashed Catheter	Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination	Unwashed catheter arm: will not be washed with culture medium.
Washed Catheter	Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination	Washed catheter arm: will be washed with culture medium before insemination

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	8 weeks after intrauterine insemination	Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks