Infertility
Conditions
Keywords
Cervical mucus, Embryo transfer, Pregnancy rate
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.
Interventions
PROCEDURECotton swab
Removal of the cervical mucus with a cotton swab before embryo transfer.
PROCEDURECannula
Removal of the cervical mucus with a cannula before embryo transfer.
Sponsors
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed