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

Primary Purpose

Infertility

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Infertility focused on measuring intrauterine insemination, pre-washing catheter

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Washed Catheter

Unwashed Catheter

Arm Description

Washed catheter arm: will be washed with culture medium before insemination

Unwashed catheter arm: will not be washed with culture medium.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04736459

First Posted

January 29, 2021

Last Updated

January 29, 2021

Sponsor

Eskisehir Osmangazi University

1. Study Identification

Unique Protocol Identification Number

NCT04736459

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 29, 2021 (Anticipated)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

intrauterine insemination, pre-washing catheter

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Washed Catheter

Arm Type

Experimental

Arm Description

Washed catheter arm: will be washed with culture medium before insemination

Arm Title

Unwashed Catheter

Arm Type

Sham Comparator

Arm Description

Unwashed catheter arm: will not be washed with culture medium.

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

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

Time Frame

8 weeks after intrauterine insemination

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vehbi Yavuz Tokgöz

Phone

+902222392979

mdtokgoz@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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