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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.
Verified October 2017 by The University of Hong Kong
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024880
First Posted: December 31, 2013
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
The University of Hong Kong
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
    Pelvic ultrasound showed intrauterine pregnancy with fetal pulsation


Secondary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 6 weeks of gestation ]
    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: June 2018
Estimated Primary Completion Date: March 2018 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 42 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024880


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

Locations
China, Hong Kong
Department of Obstetrics and Gynaecology 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

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02024880     History of Changes
Other Study ID Numbers: HKUQMHCARE002
First Submitted: December 27, 2013
First Posted: December 31, 2013
Last Update Posted: October 31, 2017
Last Verified: October 2017

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