Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical mucus removal with cotton swab | Active Comparator | Cervical mucus will be removed with cotton swab before embryo transfer |
|
| Cervical mucus removal with cannula | Active Comparator | Cervical mucus will be removed with cannula before embryo transfer |
|
| No cervical mucus removal | No Intervention | Cervical mucus will not be removed prior to embryo transfer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cotton swab | Procedure | Removal of the cervical mucus with a cotton swab before embryo transfer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detecting pregnancy after embryo transfer. | Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer. | 12 days after embryo transfer/ intervention. |
| Confirmation of fetal cardiac activity in detected pregnancy. | Evaluation of fetal cardiac activity on ultrasound. | 3-4 weeks after embryo transfer/ intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Belgin Devranoğlu, Ass. Prof. | Zeynep Kamil Women and Children's Diseases Training and Research Hospital | Principal Investigator |
| Müşerref Banu Yılmaz, Md. | Zeynep Kamil Women and Children's Diseases Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Kamil Women and Children's Diseases Training and Research Hospital | Istanbul | 34668 | Turkey (Türkiye) |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
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.
Not provided
Not provided
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.
| Cannula | Procedure | Removal of the cervical mucus with a cannula before embryo transfer. |
|
| 5 minutes after embryo transfer. |