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RECRUITING
NCT06210451
NA

Speculum Insertion During Embryo Transfer

Sponsor: Wolfson Medical Center

View on ClinicalTrials.gov

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.

Official title: Lubricant Gel Versus Sterile Water for Speculum Insertion During Embryo Transfer: a Randomized Non-inferiority Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

416

Start Date

2024-05-01

Completion Date

2026-12-31

Last Updated

2024-07-24

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Sterile water-based gel

Insertion of the speculum during ET will be performed using 5 gr of water-based, sterile gel

Locations (1)

Faculty of Medical and Health Sciences

Tel Aviv, Israel