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NCT03161119: CATH
Comparing Two Different Embryo Transfer Catheters
NA trial testing Ultrasound guided embryotransfer with Cook K-Jets-551910-S in Infertility in 352 participants. Status unknown.
1 June 2019
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 352 |
| Start date | 26 September 2017 |
| Primary completion | 1 June 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Ultrasound guided embryotransfer with Cook K-Jets-551910-S
- Ultrasound guided embryotransfer with Cook k-soft-5000 (or K-J-SP-681710 and K-J-SPPE-681710)
Conditions studied
- Infertility — all drugs for Infertility →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03161119
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03161119 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 21 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03161119.
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