Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06210451 |
| Other study ID # |
0147-23-WOMC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
January 2024 |
| Source |
Wolfson Medical Center |
| Contact |
Daniel Tairy, MD |
| Phone |
+972-54-5315875 |
| Email |
danieltairy1[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Lubrication gels are widely used in numerous gynecologic procedures in order to ease the
insertion of speculum and visualize the cervix. It was shown that applying lubricating gels
significantly decreases patient pain during vaginal speculum examination. While many
fertility specialists use lubrication gels to insert the speculum during embryo transfer
(ET), others are strongly reluctant to use gels due to concern that they might have a
detrimental effect on embryos and ET success. Similar concern was prevalent regarding the use
of lubrication gel during Pap-smear for detection of cervical dysplasia. However, several
studies have shown that the use of small amount of water-soluble gel does not change cervical
cytology. Lubrication gels might have deleterious effect on sperm motility. However, to the
best of our knowledge, there wasn't any study examining the effect of lubricant gel on ET
success.
Our hypothesis is that using a lubrication gel will not reduce the live birth rate per
transfer, but decrease patient pain during procedure.
Description:
In vitro fertilization (IVF) involves a highly complex series of events leading to the
creation of an embryo. The transfer of that embryo, the final step in the process, is seen as
a critical moment at the culmination of this incredibly intricate process. The technique of
the embryo transfer (ET) has undergone a slow evolution, but for many physicians, this step
remains relatively consistent throughout years of practice. While the procedure itself is
relatively short, physicians often have specific preferences for each of the steps involved,
either supported by evidence, learned from mentors or guided by experience and individual
success. As such, ET success rates are a statistic that generates significant pride among
physicians and are often tracked by clinics as a quality control metric. Interestingly, there
are significant outcome differences between physicians.
Numerous techniques and practices employed during ET have been studied. For some, the
evidence is robust, while for others, it is very limited. Some practices and techniques were
found to improve ET success, such as: abdominal US guidance, removal of cervical mucus, use
of a soft catheter, and placement of the embryo at a distance of more than 10 mm from the
uterine fundus. For other aspects of ET there is no sufficient evidence to decide on the
preferred practice. These include the optimal length of the procedure and rotation of the
catheter during withdrawal. Good-quality randomized clinical trials are much needed in order
to decide on the best practice. For example, there was previously a concern that the use of
powdered gloves during ET might be toxic to the embryos. However, a single RCT (n=712) has
shown that using powdered gloves resulted in similar pregnancy rates compared to unpowdered
gloves.
Lubrication gels are widely used in numerous gynecologic procedures in order to ease the
insertion of speculum and visualize the cervix. It was shown that applying lubricating gels
significantly decreases patient pain during vaginal speculum examination. While many
fertility specialists use lubrication gels to insert the speculum during ET, others are
strongly reluctant to use gels due to concern that they might have a detrimental effect on
embryos and ET success. Similar concern was prevalent regarding the use of lubrication gel
during Pap-smear for detection of cervical dysplasia. However, several studies have shown
that the use of small amount of water-soluble gel does not change cervical cytology.
Lubrication gels might have deleterious effect on sperm motility. However, to the best of our
knowledge, there wasn't any study examining the effect of lubricant gel on ET success.
Our hypothesis is that using a lubrication gel will not reduce the live birth rate per
transfer, but decrease patient pain during procedure.
