Speculum Insertion During Embryo Transfer
Lubricant Gel Versus Sterile Water for Speculum Insertion During Embryo Transfer: a Randomized Non-inferiority Clinical Trial
1 other identifier
interventional
416
1 country
1
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 24, 2024
July 1, 2024
2.7 years
December 18, 2023
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy or live birth rate.
Number of patients with ongoing pregnancy or live birth at \>20 week's gestation.
3 years
Secondary Outcomes (3)
Positive serum BHCG
3 years
Clinical pregnancy
3 years
Questionnaire
3 years
Study Arms (2)
Gel group
EXPERIMENTALSpeculum insertion using sterile water-based gel
Sterile water group
NO INTERVENTIONSpeculum insertion using sterile water
Interventions
Insertion of the speculum during ET will be performed using 5 gr of water-based, sterile gel
Eligibility Criteria
You may qualify if:
- Age 18-40
- Fresh and thawed ET
- Patients undergoing their 1st-3rd ET
- ET of 1-2 embryos
You may not qualify if:
- Age\>40
- Egg donation cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medical and Health Sciences
Tel Aviv, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Tairy, MD
Edith Wolfson Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 18, 2023
First Posted
January 18, 2024
Study Start
May 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 24, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 3 years
anonymous IPD