Comparing Two Different Embryo Transfer Catheters

NCT03161119 | Unknown DMC

• 1 other identifier: 1610
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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

Infertility

Outcome Measures

Primary Outcomes (1)

• Prevalence of difficult transfers (Number of difficult transfers/ Total transfers)

  Difficult transfers are defined as 1. for Cook k-soft-5000 catheter: advancement of the outer sheath, multiple attempts, force, required manipulation, use of a stylet or tenaculum, dilatation; 2. for Cook K-JETS-551910-S catheter: required manipulation, multiple attempts, force, the use of a stylet or tenaculum, dilatation.

  through study completion, 18 months

Secondary Outcomes (1)

• Inter-operator variability in prevalence of difficult transfers with the 2 catheters

  through study completion, 18 months

Study Arms (2)

Catheter Cook K-Jets-551910-S

EXPERIMENTAL

Catheter Cook K-Jets-551910-S consists of an outer firm and an inner ultrasoft catheter. The outer guiding catheter (17 cm long) is slightly stiff, with a preshaped curve and a rounded bulb tip to help negotiate the cervical canal. It has a depth marker at 4 cm from the tip, which can be pulled back to a second marker at 5 cm. The inner catheter (23 cm long) is made of a soft material with a rounded bullet tip. In general, the inner catheter does not negotiate the cervical canal directly but rather is introduced into the uterine cavity through the outer catheter.

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

Catheter Cook k-soft-5000 (or K-J-SP-681710, K-J-SPPE-68171)

ACTIVE COMPARATOR

This catheter system consists of an outer firm and inner soft catheter. The outer guiding catheter (15,4 cm long) is straight and made of flexible material. The inner catheter (23 cm long) is made of a very soft and flexible polyurethan. The inner catheter is introduced directly through the cervix.

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

Interventions

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

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.

Catheter Cook K-Jets-551910-S

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

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.

Catheter Cook k-soft-5000 (or K-J-SP-681710, K-J-SPPE-68171)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index (BMI) between 18 and 28,
• at least one frozen/thawed blastocyst

You may not qualify if:

• ICSI-TESE cycles

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Paolo Emanuele Levi Setti

Rozzano, MI, 20089, Italy

RECRUITING

Related Publications (1)

• Levi Setti PE, Cirillo F, Morenghi E, Immediata V, Caccavari V, Baggiani A, Albani E, Patrizio P. One step further: randomised single-centre trial comparing the direct and afterload techniques of embryo transfer. Hum Reprod. 2021 Aug 18;36(9):2484-2492. doi: 10.1093/humrep/deab178.

  PMID: 34323282 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Paolo E Levi Setti

  Istituto Clinico Humanitas

  STUDY DIRECTOR

Central Study Contacts

Paolo E Levi Setti, Professor

CONTACT

+39 0282244505; paolo.levi_setti@humanitas.it

Federico E Cirillo, MD

CONTACT

+39 0282247557; federico.cirillo@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 19, 2017
• Study Start: September 26, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 21, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)