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

NCT ID: NCT04736459

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Washed Catheter

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Unwashed Catheter

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

Group Type SHAM_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Vehbi Yavuz Tokgoz

Assocciate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Vehbi Yavuz Tokgöz

Role: CONTACT

+902222392979

Other Identifiers

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2222392979

Identifier Type: -

Identifier Source: org_study_id

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