Speculum Insertion During Embryo Transfer

ConditionIVF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorWolfson Medical Center

About this 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, 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-40

Fresh and thawed ET

Patients undergoing their 1st-3rd ET

ET of 1-2 embryos

Disqualifiers

Age>40

Egg donation cycles

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sterile water-based gel

    Other intervention

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

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: Gel groupExperimental treatment 1 intervention
Group B: Sterile water groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ongoing pregnancy or live birth rate.

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

Time frame
3 years

Secondary outcomes

1

Positive serum BHCG

Number of patients with positive serum BHCG test.

Time frame
3 years
2

Clinical pregnancy

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

Time frame
3 years
3

Questionnaire

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

Time frame
3 years

Other outcomes

Sponsors and contacts

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