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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02024880
First received: December 27, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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
Infertility
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

Resource links provided by NLM:


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: March 2016
Estimated Primary Completion Date: December 2015 (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
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
Other Name: Sydney IVF catheters

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02024880

Contacts
Contact: Ernest HY Ng, MD 852-22553400 nghye@hku.hk

Locations
China, Hong Kong
Department of Obstetrics and Gynaecology Not yet recruiting
Hong Kong, Hong Kong, China
Contact: Ernest HY NG, MD    852-22553400    nghye@hku.hk   
Principal Investigator: Ernest HY NG, MD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ernest HY Ng, MD The University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02024880     History of Changes
Other Study ID Numbers: HKUQMHCARE002
Study First Received: December 27, 2013
Last Updated: December 27, 2013
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 25, 2014