Study Stopped
The ET catheters were outdated.
Comparison of Two Embryo Transfer Catheters in Patients Undergoing in Vitro Fertilization and Embryo Transfer
A Randomized Single-blind Comparison of Two Embryo Transfer Catheters in Patients Undergoing in Vitro Fertilization and Embryo Transfer
1 other identifier
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedApril 29, 2021
July 1, 2020
6.9 years
December 27, 2013
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ongoing pregnancy rate
Pelvic ultrasound showed intrauterine pregnancy with fetal pulsation
10 weeks of gestation
Secondary Outcomes (1)
Clinical pregnancy rate
6 weeks of gestation
Study Arms (2)
Protective catheter group
EXPERIMENTALProtective catheter group uses Guardia™ Pro Protective ET catheter from Cook.
Conventional catheter group
ACTIVE COMPARATORConventional catheter group uses Sydney IVF catheter from Cook.
Interventions
The tip of this catheter is protected on insertion of the catheter.
A standard embryo catheter
Eligibility Criteria
You may qualify if:
- (i) ET in the fresh cycle (ii) Age \<43 year (iii) Normal uterine cavity shown on ultrasound scanning
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest HY Ng, MD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2013
First Posted
December 31, 2013
Study Start
January 1, 2014
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
April 29, 2021
Record last verified: 2020-07