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

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.

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: Cotton swab; Procedure: Cannula

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34668
    • Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Investigators: Principal Investigator: Belgin Devranoğlu, Ass. Prof., Zeynep Kamil Women and Children's Diseases Training and Research Hospital; Study Director: Müşerref Banu Yılmaz, Md., Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 8, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cervical mucus; Embryo transfer; Pregnancy rate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 90-07.April.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No