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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 183
- Locations
- 2
- Primary Endpoint
- Detecting pregnancy after embryo transfer.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
No cervical mucus removal
Cervical mucus will not be removed prior to embryo transfer
Cervical mucus removal with cotton swab
Cervical mucus will be removed with cotton swab before embryo transfer
Intervention: Cotton swab (Procedure)
Cervical mucus removal with cannula
Cervical mucus will be removed with cannula before embryo transfer
Intervention: Cannula (Procedure)
Outcomes
Primary Outcomes
Detecting pregnancy after embryo transfer.
Time Frame: 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.
Time Frame: 3-4 weeks after embryo transfer/ intervention.
Evaluation of fetal cardiac activity on ultrasound.
Secondary Outcomes
- Success of embryo transfer during intervention.(5 minutes after embryo transfer.)
Investigators
enis ozkaya
Associate Professor, Specialist in Obstetrics and Gynecology
Zeynep Kamil Maternity and Pediatric Research and Training Hospital