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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Cotton swab; Procedure: Cannula

• Registration Number: NCT04888091
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-17
• Study Start: 2021-06-25
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical mucus removal with cotton swab	Cotton swab	Cervical mucus will be removed with cotton swab before embryo transfer
Cervical mucus removal with cannula	Cannula	Cervical mucus will be removed with cannula before embryo transfer

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Success of embryo transfer during intervention.	5 minutes after embryo transfer.	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.

Trial Locations

Locations (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital; 🇹🇷 Istanbul, Turkey