Randomized, Standard-Controlled, Study to Evaluate the Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit
|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: NCT04142112|
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility Infertility, Male||Device: Ohana IVF Sperm Preparation Kit (OHB035) Device: Standard IVF Preparation Kit (OHB037)||Not Applicable|
This blinded, randomized, standard-controlled, paired study will be performed in approximately 83 healthy couples (pairs of male and female subjects), who are appropriate candidates for IVF in six fertility centers located in the United States (US).
The study will capture the selection of the best embryo for transfer and follow-up on pregnancy outcomes that result from the transfer of the selected embryo following the IVF procedure, and the results of safety assessments.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Blinded, Standard-Controlled, Study to Evaluate the Safety and Efficacy of Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit OHB035 on IVF|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||March 26, 2020|
|Estimated Study Completion Date :||July 26, 2021|
Experimental: Ohana IVF Sperm Preparation Kit
Samples in the Ohana IVF Sperm Preparation Kit group will undergo product-specific multistep processing in the lab prior to insemination.
Device: Ohana IVF Sperm Preparation Kit (OHB035)
The Ohana IVF Sperm Preparation Kit (OHB035) contains media for processing sperm through a series of timed steps prior to insemination with oocytes.
Active Comparator: Standard IVF Preparation Kit
Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination.
Device: Standard IVF Preparation Kit (OHB037)
The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes.
- Blastocyst Evaluation [ Time Frame: Three months following last patient treated. ]To compare the difference in the number of high-quality euploid blastocysts per mature oocyte in subjects undergoing split IVF insemination using sperm prepared with Ohana IVF sperm preparation kit OHB035 (OHANA) versus sperm prepared using a Standard IVF sperm preparation kit OHB037 (STANDARD)
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): NCT04142112
|Contact: Medical Directorfirstname.lastname@example.org|
|United States, Florida|
|Women's Medical Research Group, LLC||Recruiting|
|Clearwater, Florida, United States, 33759|
|United States, Maryland|
|Shady Grove Fertility||Recruiting|
|Rockville, Maryland, United States, 20850|
|United States, Massachusetts|
|Boston IVF Fertility Clinic||Recruiting|
|Waltham, Massachusetts, United States, 02451|
|United States, North Carolina|
|Carolina Conceptions, P.A.||Recruiting|
|Raleigh, North Carolina, United States, 27607|
|United States, Pennsylvania|
|Main Line Fertility Center||Recruiting|
|Bryn Mawr, Pennsylvania, United States, 19010|
|United States, Texas|
|Center for Assisted Reproduction||Recruiting|
|Bedford, Texas, United States, 76022|