Comparison of the Effect of Cervical Mucus Cleaning Method Applied Before Embryo Transfer on Pregnancy Rates.

NCT ID: NCT04888091

Last Updated: 2024-02-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2022-07-08

Brief Summary

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To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.

Detailed Description

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All patients will be informed about the study and those who give written consent will be included in the study.

Women undergoing good quality embryo transfer will be assigned to one of the 3 arms of the study according to the previously determined randomization chart. The first evaluation of the patient will be made on the 12th day after embryo transfer. Pregnancy status will be evaluated with serum βhcg value. If pregnancy is confirmed by serum βhcg value, fetal viability will be evaluated by ultrasound 4 weeks after transfer.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a parallel model interventional study. The sample size is calculated as 180 patients. Sixty patients will be assigned to each study arm by randomization. It is planned to use random computerized numbers for randomization. İn arm 1, cervical mucus will be removed with a cotton swab before embryo transfer. In arm 2, cervical mucus will be removed with a canula before embryo transfer. In arm 3, cervical mucus will not be removed.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant masking: Embryo transfer is done while the patient is lying in lithotomy position in accordance with gynecological examination. The patient is informed about the preparations before the embryo transfer and then the examination is completed. The patient will not be informed about the method used for removal of the cervical mucus. The patient's lying position also does not allow observation of the material used to remove cervical mucus.

Study Groups

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Cervical mucus removal with cotton swab

Cervical mucus will be removed with cotton swab before embryo transfer

Group Type ACTIVE_COMPARATOR

Cotton swab

Intervention Type PROCEDURE

Removal of the cervical mucus with a cotton swab before embryo transfer.

Cervical mucus removal with cannula

Cervical mucus will be removed with cannula before embryo transfer

Group Type ACTIVE_COMPARATOR

Cannula

Intervention Type PROCEDURE

Removal of the cervical mucus with a cannula before embryo transfer.

No cervical mucus removal

Cervical mucus will not be removed prior to embryo transfer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cotton swab

Removal of the cervical mucus with a cotton swab before embryo transfer.

Intervention Type PROCEDURE

Cannula

Removal of the cervical mucus with a cannula before embryo transfer.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 21-40 years old women,
* Women undergoing good quality embryo transfer,
* Women who are eligible for a single or double embryo transfer.

Exclusion Criteria

* If there is a diagnosis of a uterine anomaly,
* If there is a diagnosis of myoma uteri,
* If there is a diagnosis of rheumatological disease,
* Women to be transferred other than good quality embryo,
* Hİstory of previous pelvic, gynecological operation.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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enis ozkaya

Associate Professor, Specialist in Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Belgin Devranoğlu, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Müşerref Banu Yılmaz, Md.

Role: STUDY_DIRECTOR

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Locations

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Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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90-07.April.2021

Identifier Type: -

Identifier Source: org_study_id

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