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

Infertility Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888091
• Other study ID #: 90-07.April.2021
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: July 8, 2022

Study information

• Verified date: February 2024
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 8, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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,
• HIstory of previous pelvic, gynecological operation.

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Cotton swab
Removal of the cervical mucus with a cotton swab before embryo transfer.
• Cannula
Removal of the cervical mucus with a cannula before embryo transfer.

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Women and Children's Diseases Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detecting pregnancy after embryo transfer.	Confirmation of pregnancy with serum ßhcg value at the earliest 12th day after embryo transfer.	12 days after embryo transfer/ intervention.
Primary	Confirmation of fetal cardiac activity in detected pregnancy.	Evaluation of fetal cardiac activity on ultrasound.	3-4 weeks after embryo transfer/ intervention.
Secondary	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.