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

E

Eskisehir Osmangazi University

Status

Unknown

Conditions

Infertility

Treatments

Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination

Study type

Interventional

Funder types

Other

Identifiers

NCT04736459
2222392979

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups

Washed Catheter
Experimental group
Description:
Washed catheter arm: will be washed with culture medium before insemination
Treatment:
Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination
Unwashed Catheter
Sham Comparator group
Description:
Unwashed catheter arm: will not be washed with culture medium.
Treatment:
Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination

Trial contacts and locations

0

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Central trial contact

Vehbi Yavuz Tokgöz

Data sourced from clinicaltrials.gov

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