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Comparing Two Different Embryo Transfer Catheters

NCT03161119 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2019-03-21

No results posted yet for this study

Summary

Numerous published trials now document that the embryo transfer (ET) procedure has a huge impact on pregnancy and delivery rates after IVF (In Vitro Fertilization).

To compare the ease of use (defined as the rate of successful atraumatic insertion) of different types of embryo transfer (ET) catheters.

This prospective randomized unblinded controlled clinical trial is performed to determine if there is any difference in ease of use among 2 different catheters : Cook k-soft-5000, Cook K-JETS-551910-S.

Inclusion criteria: patients \< / = 38 years of age, body mass index (BMI) between 18 and 28, at least one frozen-thawed blastocyst transferred.

Exclusion criteria: ICSI (Intracytoplasmic Sperm Injection)-TESE (Testicular Sperm Extraction) IVF cycles.

A number of 352 consecutive women undergoing embryo transfer will be selected for this prospective, randomized controlled trial. Two protocols for endometrial preparation will be used before frozen/thawed blastocyst transfer: the modified spontaneous protocol and the oral/transdermal preparation protocol. ET will be done with patient in lithotomy position, under ultrasound guidance. No anesthesia will be used for the procedure.

176 patients will be enrolled in this trial and randomized to enter one of the two catheter group.

Conditions

Interventions

DEVICE

Ultrasound guided embryotransfer with Cook K-Jets-551910-S

On the day of ET, patient will be asked to come with full bladder. ET will be done with patient in lithotomy position. No anesthesia will be used for the procedure. Under sterile condition, vaginal parts will be cleaned with saline and draped and speculum inserted to expose cervix. Cervical mucus and cervix will be cleaned with sterile media. The Et procedure itself is standardized as far as possible amongst the participating physicians to eliminate bias.

DEVICE

Ultrasound guided embryotransfer with Cook k-soft-5000 (or K-J-SP-681710 and K-J-SPPE-681710)

On the day of ET, patient will be asked to come with full bladder. ET will be done with patient in lithotomy position. No anesthesia will be used for the procedure. Under sterile condition, vaginal parts will be cleaned with saline and draped and speculum inserted to expose cervix. Cervical mucus and cervix will be cleaned with sterile media. The Et procedure itself is standardized as far as possible amongst the participating physicians to eliminate bias.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Paolo E Levi Setti · Istituto Clinico Humanitas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2019-06-01
Completion
2019-12-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161119 on ClinicalTrials.gov