Using lubrication gel during embryo transfer in IVF
Lubricant Gel Versus Sterile Water for Speculum Insertion During Embryo Transfer: a Randomized Non-inferiority Clinical Trial
This study is testing whether using a special lubrication gel during embryo transfer in IVF can help women aged 18-40 have a higher chance of a live birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 416 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Wolfson Medical Center Government |
| Locations | 1 site (Tel Aviv) |
| Trial ID | NCT06210451 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of using a sterile water-based lubrication gel during the embryo transfer (ET) process in in vitro fertilization (IVF). The study aims to determine whether the gel affects the live birth rate per transfer, addressing concerns that it may hinder ET success. Participants will include women aged 18-40 undergoing their first to third ET with fresh or thawed embryos. The trial will compare outcomes between those who receive the gel and those who do not, contributing to the understanding of best practices in embryo transfer.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 undergoing their first to third embryo transfer with fresh or thawed embryos.
Not a fit: Patients over the age of 40 or those undergoing egg donation cycles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient comfort during embryo transfer without compromising the chances of a successful pregnancy.
How similar studies have performed: Previous studies have shown that the use of small amounts of water-soluble gel does not negatively impact cervical cytology, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-40 * Fresh and thawed ET * Patients undergoing their 1st-3rd ET * ET of 1-2 embryos Exclusion Criteria: * Age\>40 * Egg donation cycles
Where this trial is running
Tel Aviv
- Faculty of Medical and Health Sciences — Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Daniel Tairy, MD — Edith Wolfson Medical Center
- Study coordinator: Daniel Tairy, MD
- Email: danieltairy1@gmail.com
- Phone: +972-54-5315875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.