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

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04888091

Collaborator

(none)

180

Enrollment

Location

Arms

6.2

Anticipated Duration (Months)

29.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: Cotton swab Procedure: Cannula	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jun 25, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
Confirmation of fetal cardiac activity in detected pregnancy. [3-4 weeks after embryo transfer/ intervention.]
Evaluation of fetal cardiac activity on ultrasound.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zeynep Kamil Women and Children's Diseases Training and Research Hospital	Istanbul		Turkey	34668

Sponsors and Collaborators

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

enis ozkaya, Associate Professor, Specialist in Obstetrics and Gynecology, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

ClinicalTrials.gov Identifier:

NCT04888091

Other Study ID Numbers:

90-07.April.2021

First Posted:

May 17, 2021

Last Update Posted:

Jul 28, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by enis ozkaya, Associate Professor, Specialist in Obstetrics and Gynecology, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Cervical mucus

Embryo transfer

Pregnancy rate

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jul 28, 2021