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NCT Number: NCT06210451

Speculum Insertion During Embryo Transfer

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.

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Key information

Conditions

IVF

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medical and Health Sciences

Tel Aviv, Israel

Location status: Recruiting

Location contact

Yossi Mizrachi, MD

CONTACT

[email protected]

972545234053

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterile water-based gel

Other

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

Primary outcomes

  1. Ongoing pregnancy or live birth rate.

    Time frame: 3 years

    Number of patients with ongoing pregnancy or live birth at >20 week's gestation.

Secondary outcomes

  1. Positive serum BHCG

    Time frame: 3 years

    Number of patients with positive serum BHCG test.

  2. Clinical pregnancy

    Time frame: 3 years

    Number of patients with transvaginal ultrasound test demonstrating fetal cardiac activity.

  3. Questionnaire

    Time frame: 3 years

    Pain score on a scale of 1 to 10, where 1 indicates no pain and 10 indicates worst possible pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Tairy, MD

CONTACT

[email protected]

+972-54-5315875

Yossi Mizrachi, MD

CONTACT

[email protected]

+972-54-5234053

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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