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NCT03161119: CATH

Comparing Two Different Embryo Transfer Catheters

Status unknown NA Last updated 21 March 2019
What this trial tests

NA trial testing Ultrasound guided embryotransfer with Cook K-Jets-551910-S in Infertility in 352 participants. Status unknown.

Timeline
26 September 2017
Primary endpoint
1 June 2019
1 December 2019

Quick facts

Lead sponsorIstituto Clinico Humanitas
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment352
Start date26 September 2017
Primary completion1 June 2019
Estimated completion1 December 2019
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Clinico Humanitas

Who can join

Adults 18 to 38, female only, with Infertility. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. One step further: randomised single-centre trial comparing the direct and afterload techniques of embryo transfer.
    Levi Setti PE, Cirillo F, Morenghi E, Immediata V, et al · · 2021 · cited 7× · PMID 34323282 · DOI 10.1093/humrep/deab178

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Other recruiting trials for Infertility

Currently open trials in the same condition.

Other Istituto Clinico Humanitas trials

Trials by the same sponsor.

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Data sources for this page

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