Controlled Ovarian Stimulation and Human Uterine Lavage
|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: NCT03426007|
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility, Female||Procedure: Uterine lavage||Not Applicable|
The study is a prospective, multi- center, multiple-arm, feasibility study to evaluate the safety and efficacy of the Previvo System in the recovery of embryos.
This study will recruit up to 500 healthy premenopausal volunteers. Subjects will undergo either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI) and have the lavage procedure performed 4-6 days post IUI. It is anticipated that embryos recovered will be cryopreserved for future use or donated for future use.
Subjects will be followed up with for up to 30 days after the lavage procedure. All data will be collected on paper CRFs and analyzed by the Principal Investigator and Study Sponsor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Controlled Ovarian Stimulation and Human Uterine Lavage: A Feasibility Study|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Uterine Lavage
Embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
Procedure: Uterine lavage
embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
- Serious Adverse Event Collection [ Time Frame: 30-Days ]Assessment of pain during procedure, bleeding experienced during procedure, and infection symptoms experienced subsequent to procedure. Assessment of fluid recovery, fluid loss through cervix, fluid accumulation in the uterus and fluid loss through fallopian tubes.
- Recovery of Embryos [ Time Frame: 1 Day ]Demonstrate the Previvo Uterine Lavage System's ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
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): NCT03426007
|Contact: Alex Nidalfirstname.lastname@example.org|
|Contact: Gheda Sahyun, MAemail@example.com|
|Punta Mita Hospital||Recruiting|
|Punta de Mita, Nayarit, Mexico, 63734|
|Contact: Sam Najmabadi, MD 310-466-5132 firstname.lastname@example.org|
|Principal Investigator: Sam Najmabadi, MD|
|Study Director:||Gheda Sahyun, MA||Sponsor GmbH|