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

January 29, 2021 updated by: Vehbi Yavuz Tokgoz, Eskisehir Osmangazi University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Washed Catheter
Washed catheter arm: will be washed with culture medium before insemination
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
Sham Comparator: Unwashed Catheter
Unwashed catheter arm: will not be washed with culture medium.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks after intrauterine insemination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 29, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2222392979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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