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

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cotton swab
Cannula
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Cervical mucus, Embryo transfer, Pregnancy rate

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Zeynep Kamil Women and Children's Diseases Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Cervical mucus removal with cotton swab

Cervical mucus removal with cannula

No cervical mucus removal

Arm Description

Cervical mucus will be removed with cotton swab before embryo transfer

Cervical mucus will be removed with cannula before embryo transfer

Cervical mucus will not be removed prior to embryo transfer

Outcomes

Primary Outcome Measures

Detecting pregnancy after embryo transfer.
Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.
Confirmation of fetal cardiac activity in detected pregnancy.
Evaluation of fetal cardiac activity on ultrasound.

Secondary Outcome Measures

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.

Full Information

First Posted
May 3, 2021
Last Updated
July 21, 2021
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04888091
Brief Title
Comparison of the Effect of Cervical Mucus Removal With Cotton Swab or Cannula on Pregnancy Rates Before Embryo Transfer.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Cervical mucus, Embryo transfer, Pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical mucus removal with cotton swab
Arm Type
Active Comparator
Arm Description
Cervical mucus will be removed with cotton swab before embryo transfer
Arm Title
Cervical mucus removal with cannula
Arm Type
Active Comparator
Arm Description
Cervical mucus will be removed with cannula before embryo transfer
Arm Title
No cervical mucus removal
Arm Type
No Intervention
Arm Description
Cervical mucus will not be removed prior to embryo transfer
Intervention Type
Procedure
Intervention Name(s)
Cotton swab
Intervention Description
Removal of the cervical mucus with a cotton swab before embryo transfer.
Intervention Type
Procedure
Intervention Name(s)
Cannula
Intervention Description
Removal of the cervical mucus with a cannula before embryo transfer.
Primary Outcome Measure Information:
Title
Detecting pregnancy after embryo transfer.
Description
Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.
Time Frame
12 days after embryo transfer/ intervention.
Title
Confirmation of fetal cardiac activity in detected pregnancy.
Description
Evaluation of fetal cardiac activity on ultrasound.
Time Frame
3-4 weeks after embryo transfer/ intervention.
Secondary Outcome Measure Information:
Title
Success of embryo transfer during intervention.
Description
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.
Time Frame
5 minutes after embryo transfer.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enis Özkaya, Ass. Prof.
Phone
+905054742452
Email
enozkaya1979@gmail.com
Facility Information:
Facility Name
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Habibe Ayvacı Taşan
Phone
+905425310018
Email
habibayvaci@hotmail.com
First Name & Middle Initial & Last Name & Degree
Enis Özkaya, Ass. Prof.
Phone
+905054742459
Email
enozkaya1979@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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