Clinical trial NCT04888091: Comparison of the Effect of Cervical Mucus Cleaning Method Applied Before Embryo Transfer on Pregnancy Rates.
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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Cervical mucus
Embryo transfer
Pregnancy rate
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 183
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 3, cervical mucus will not be removed.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detecting pregnancy after embryo transfer.
timeFrame: 12 days after embryo transfer/ intervention.
measure: Confirmation of fetal cardiac activity in detected pregnancy.
timeFrame: 3-4 weeks after embryo transfer/ intervention.
Secondary outcomes:
measure: Success of embryo transfer during intervention.
timeFrame: 5 minutes after embryo transfer.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Study officials:
affiliation: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
name: Belgin Devranoğlu, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
name: Müşerref Banu Yılmaz, Md.
role: STUDY_DIRECTOR
References: