Speculum Insertion During Embryo Transfer

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, to the best of our knowledge, there wasn't any study examining the effect of lubricant gel on ET success.

Our hypothesis is that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: IVF
• Intervention / Treatment: Other: Sterile water-based gel

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, to the best of our knowledge, there wasn't any study examining the effect of lubricant gel on ET success.

Our hypothesis is that using a lubrication gel will not reduce the live birth rate per transfer, but decrease patient pain during procedure.

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Tairy, MD; Phone Number: +972-54-5315875; Email: danieltairy1@gmail.com
• Study Contact Backup: Name: Yossi Mizrachi, MD; Phone Number: +972-54-5234053; Email: mizrachi.yossi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gel group; Speculum insertion using sterile water-based gel	Other: Sterile water-based gel; Insertion of the speculum during ET will be performed using 5 gr of water-based, sterile gel
No Intervention: Sterile water group; Speculum insertion using sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy or live birth rate.	Number of patients with ongoing pregnancy or live birth at >20 week's gestation.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive serum BHCG	Number of patients with positive serum BHCG test.	3 years
Clinical pregnancy	Number of patients with transvaginal ultrasound test demonstrating fetal cardiac activity.	3 years
Questionnaire	Pain score on a scale of 1 to 10, where 1 indicates no pain and 10 indicates worst possible pain.	3 years

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Daniel Tairy, MD, Edith Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: IVF; RCT; Embryo transfer; Gel
• Other Study ID Numbers: 0147-23-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: anonymous IPD
• IPD Sharing Time Frame: 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No