Speculum Insertion During Embryo Transfer

NCT ID: NCT06210451

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gel group

Speculum insertion using sterile water-based gel

Group Type: EXPERIMENTAL

Sterile water-based gel

Intervention Type: OTHER

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

Sterile water group

Speculum insertion using sterile water

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sterile water-based gel

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yossi Mizrachi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Tairy, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

Faculty of Medical and Health Sciences

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Daniel Tairy, MD

Role: CONTACT

danieltairy1@gmail.com

+972-54-5315875

Yossi Mizrachi, MD

Role: CONTACT

mizrachi.yossi@gmail.com

+972-54-5234053

Facility Contacts

Yossi Mizrachi, MD

Role: primary

mizrachi.yossi@gmail.com

972545234053

Other Identifiers

0147-23-WOMC

Identifier Type: -

Identifier Source: org_study_id