Comparison of Two Embryo Transfer Catheters in Patients Undergoing in Vitro Fertilization and Embryo Transfer
|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.|
|ClinicalTrials.gov Identifier: NCT02024880|
Recruitment Status : Recruiting
First Posted : December 31, 2013
Last Update Posted : May 4, 2018
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 or disease||Intervention/treatment||Phase|
|Infertility||Device: Protective catheter group Device: Conventional catheter group||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Single-blind Comparison of Two Embryo Transfer Catheters in Patients Undergoing in Vitro Fertilization and Embryo Transfer|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||August 30, 2019|
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
- ongoing pregnancy rate [ Time Frame: 10 weeks of gestation ]Pelvic ultrasound showed intrauterine pregnancy with fetal pulsation
- Clinical pregnancy rate [ Time Frame: 6 weeks of gestation ]Pelvic ultrasound should an intrauterine sac with crown rump length corresponding to 6 weeks
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
|Contact: Ernest HY Ng, MDemail@example.com|
|China, Hong Kong|
|Department of Obstetrics and Gynaecology||Recruiting|
|Hong Kong, Hong Kong, China|
|Contact: Ernest HY NG, MD 852-22553400 firstname.lastname@example.org|
|Principal Investigator: Ernest HY NG, MD|
|Principal Investigator:||Ernest HY Ng, MD||The University of Hong Kong|