Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619379
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During the Embryo Transfer Process
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During the Embryo Transfer Process
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Speculum
Brief Summary:
Investigators aim to investigate possible affects of a speculum material and retention strategy on IVF pregnancy results The study is planned as a prospective randomized control trial All of the clinical managements including the embryo transfers will be performed by the same gynecologist for homogeneity of the study Only the cases with good implantation potentials are going to be included Therefore transfers with cleavage embryos and blastocysts rather than good and top quality will be excluded All patients included to final statistical analysis will receive the same luteal support
Detailed Description:
Participants will be included among the 20 - 40 years old women applying to for IVF Women with mullerian anomalies and couples with chromosomal abnormalities will be excluded Histrory of recurrent implantation failure thin endometrium will also be considered as exclusion criterias Participants who are initially included in the study will be excluded either the demanded preimplantation genetik testing for aneuploidy optionally or if the embryo transfer is performed under general anesthesia or the embryo transfer is recorded as difficult transfer
The participants included in the study will be randomised for the speculum material metal or plastic and also for the retention time of the speculum out of the vagina Just immediately before applying the speculum to the patient the material temperature will be measured and recorded with a thermometer capable of digital and object measurement
All of the transfers will be performed with the same technique After the embryo transfer is made and the transfer catheter is withdrawn the speculum will be extracted according to the randomization If the speculum is not extracted immediately the chronometer will be started and the extraction will be done either in the 60 second or 420 second 7 minutes according to the randomization As there are two speculum materials and three retention time arms in the design a total of 6 groups will be formed after crossover Data gained in this way will be analyzed and their demographic data and embryological parameters will be evaluated and the implantation rates pregnancy rates and clinical pregnancy rates of the patients will be determined
The participants included in the study will be randomised for the speculum material metal or plastic and also for the retention time of the speculum out of the vagina Just immediately before applying the speculum to the patient the material temperature will be measured and recorded with a thermometer capable of digital and object measurement
All of the transfers will be performed with the same technique After the embryo transfer is made and the transfer catheter is withdrawn the speculum will be extracted according to the randomization If the speculum is not extracted immediately the chronometer will be started and the extraction will be done either in the 60 second or 420 second 7 minutes according to the randomization As there are two speculum materials and three retention time arms in the design a total of 6 groups will be formed after crossover Data gained in this way will be analyzed and their demographic data and embryological parameters will be evaluated and the implantation rates pregnancy rates and clinical pregnancy rates of the patients will be determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None