IVFNCT06210451
Speculum Insertion During Embryo Transfer
A study testing Sterile water-based gel in people with IVF, run by Wolfson Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- Sterile water-based gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- Fresh and thawed ET
- Patients undergoing their 1st-3rd ET
- ET of 1-2 embryos
Who cannot join
- Age>40
- Egg donation cycles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Faculty of Medical and Health Sciences
Tel Aviv
Yossi Mizrachi, MD, 972545234053, mizrachi.yossi@gmail.com
About this study
Official title: Lubricant Gel Versus Sterile Water for Speculum Insertion During Embryo Transfer: a Randomized Non-inferiority Clinical Trial
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, there wasn't any study examining the effect of lubricant gel on ET success.
The investigators hypothesize that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.
Read the detailed 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, there wasn't any study examining the effect of lubricant gel on ET success.
The investigators hypothesize that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.
- Conditions
- IVF
- Being tested
- Sterile water-based gel
- Keywords
- IVF, Embryo transfer, Gel, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile water-based gelOther
Insertion of the speculum during ET will be performed using 5 gr of water-based, sterile gel
| Study group | Role | What they receive |
|---|---|---|
| Gel group | Experimental | Speculum insertion using sterile water-based gel Receives: Other: Sterile water-based gel |
| Sterile water group | No intervention | Speculum insertion using sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy or live birth rate.
Number of patients with ongoing pregnancy or live birth at >20 week's gestation.
Measured: 3 years
Secondary outcomes (3)
Positive serum BHCG
Number of patients with positive serum BHCG test.
Measured: 3 years
Clinical pregnancy
Number of patients with transvaginal ultrasound test demonstrating fetal cardiac activity.
Measured: 3 years
Questionnaire
Pain score on a scale of 1 to 10, where 1 indicates no pain and 10 indicates worst possible pain.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yossi Mizrachi, Wolfson Medical Center
- Investigators
- Daniel Tairy, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210451
- Sponsor's protocol ID
- 0147-23-WOMC
- Status last verified
- Jul 2024
- First submitted
- 18 Dec 2023
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymous IPD
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lubricant Gel Versus Sterile Water for Speculum Insertion During Embryo Transfer: a Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06210451
- Acronym / sponsor ID
- 0147-23-WOMC
- Conditions
- IVF
- Keywords
- IVF, Embryo transfer, Gel, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, there wasn't any study examining the effect of lubricant gel on ET success.
The investigators hypothesize that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.
Detailed 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, there wasn't any study examining the effect of lubricant gel on ET success.
The investigators hypothesize that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel group | Experimental | Other: Sterile water-based gelSpeculum insertion using sterile water-based gel |
| Sterile water group | No intervention | –Speculum insertion using sterile water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-40
- Fresh and thawed ET
- Patients undergoing their 1st-3rd ET
- ET of 1-2 embryos
Key exclusion criteria (2 listed)
- Age>40
- Egg donation cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile water-based gelInsertion of the speculum during ET will be performed using 5 gr of water-based, sterile gel | Other | Gel group |
Primary outcome
Ongoing pregnancy or live birth rate.
Time frame: 3 years
Number of patients with ongoing pregnancy or live birth at >20 week's gestation.
3 secondary outcomes
Positive serum BHCG
Time frame: 3 years
Clinical pregnancy
Time frame: 3 years
Questionnaire
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: Yes. anonymous IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Tairy, MD principal investigator
Edith Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile water-based gel in people with IVF, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Tairy, MD (+972-54-5315875, danieltairy1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy or live birth rate. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.