Comparison of the Effect of Cervical Mucus Removal With Cotton Swab or Cannula on Pregnancy Rates Before Embryo Transfer.

Study Overview
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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.

Official Title
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The Effect of Two Different Cervical Mucus Removal Methods on Pregnancy Rates. 180 Cases Will be Randomized Into 3 Groups for Cervical Mucus Intervention. Removal With Cotton Swab, Removal With Cannula and Mucus Left on Cervix.

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Cotton swab
* Procedure: Cannula


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 cervical mucus will not be removed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cervical mucus removal with cotton swab<br>Cervical mucus will be removed with cotton swab before embryo transfer | Procedure: Cotton swab<br>* Removal of the cervical mucus with a cotton swab before embryo transfer.<br>|
| Active Comparator: Cervical mucus removal with cannula<br>Cervical mucus will be removed with cannula before embryo transfer | Procedure: Cannula<br>* Removal of the cervical mucus with a cannula before embryo transfer.<br>|
| No Intervention: No cervical mucus removal<br>Cervical mucus will not be removed prior to embryo transfer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting pregnancy after embryo transfer. | Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer. | 12 days after embryo transfer/ intervention. | 
| Confirmation of fetal cardiac activity in detected pregnancy. | Evaluation of fetal cardiac activity on ultrasound. | 3-4 weeks after embryo transfer/ intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of embryo transfer during intervention. | In some cases, the embryo is transferred to the endometrial cavity and comes back with the transfer cannula. For this reason, the embryology laboratory checks the transfer cannula after the transfer. If the embryo is still in the embryo transfer cannula, a second attempt is made for embryo transfer. As a secondary outcome, we will evaluate the success in the first attempt for embryo transfer. | 5 minutes after embryo transfer. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical mucus, Embryo transfer, Pregnancy rate