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Comparison of Two Embryo Transfer Catheters in Patients Undergoing in Vitro Fertilization and Embryo Transfer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by The University of Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong Identifier:
First received: December 27, 2013
Last updated: December 10, 2015
Last verified: December 2015

In-vitro fertilization (IVF) treatment involves development of multiple follicles following ovarian stimulation, oocyte retrieval and embryo transfer (ET). ET is the final and most crucial step of IVF treatment.

The ET catheter has to pass through the endocervical canal to go into the uterine cavity through the internal os. The endocervical canal may be filled up with mucus or blood. Embryos trapped in the mucus or blood after the passage of the endocervical canal may not be able to implant into the endometrium. Guardia™ Pro Protective ET catheter is designed to allow the safe passage of embryos through cervical mucus and blood as its outer sheath protects the embryo through entry and then opens in petals to further advance the inner catheter and gently place the embryo.

The hypothesis of this study is that the pregnancy rate is significantly higher after ET using protective ET catheters.

Condition Intervention Phase
Device: Protective catheter group
Device: Conventional catheter group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Single-blind Comparison of Two Embryo Transfer Catheters in Patients Undergoing in Vitro Fertilization and Embryo Transfer

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 10 weeks of gestation ] [ Designated as safety issue: No ]
    Pelvic ultrasound showed intrauterine pregnancy with fetal pulsation

Secondary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 6 weeks of gestation ] [ Designated as safety issue: No ]
    Pelvic ultrasound should an intrauterine sac with crown rump length corresponding to 6 weeks

Estimated Enrollment: 720
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protective catheter group
Protective catheter group uses Guardia™ Pro Protective ET catheter from Cook.
Device: Protective catheter group
The tip of this catheter is protected on insertion of the catheter.
Other Name: Guardia™ Pro Protective ET catheter
Active Comparator: Conventional catheter group
Conventional catheter group uses Sydney IVF catheter from Cook.
Device: Conventional catheter group
A standard embryo catheter
Other Name: Sydney IVF catheters

  Show Detailed Description


Ages Eligible for Study:   up to 42 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

(i) ET in the fresh cycle (ii) Age <43 year (iii) Normal uterine cavity shown on ultrasound scanning

Exclusion Criteria:

(i) Three previous IVF cycles (ii) Natural IVF or IVM cycles (iii) Presence of hydrosalpinx on pelvic scanning (iv) Transfer of grade 5 embryos (v) Blastocyst transfer (vi) Use of donor oocytes (vii) Pre-implantation genetic diagnosis and (viii) Previously joined in the same study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02024880

Contact: Ernest HY Ng, MD 852-22553400

China, Hong Kong
Department of Obstetrics and Gynaecology Recruiting
Hong Kong, Hong Kong, China
Contact: Ernest HY NG, MD    852-22553400   
Principal Investigator: Ernest HY NG, MD         
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Ernest HY Ng, MD The University of Hong Kong
  More Information

Responsible Party: The University of Hong Kong Identifier: NCT02024880     History of Changes
Other Study ID Numbers: HKUQMHCARE002 
Study First Received: December 27, 2013
Last Updated: December 10, 2015
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
in vitro fertilization
embryo transfer
transfer catheter

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on October 21, 2016