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Clinical Trials/NCT04736459
NCT04736459UnknownNot Applicable

Does Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination Have an Effect on Pregnancy Rates?

Eskisehir Osmangazi University0 sites100 target enrollmentStarted: January 29, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Primary Endpoint
Clinical pregnancy rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: 8 weeks after intrauterine insemination

Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Eskisehir Osmangazi University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vehbi Yavuz Tokgoz

Assocciate Professor

Eskisehir Osmangazi University

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