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Randomized, Standard-Controlled, Study to Evaluate the Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit

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ClinicalTrials.gov Identifier: NCT04142112
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ohana BioSciences

Study Description
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Brief Summary:
Multi-centered, randomized controlled study, evaluating the safety and efficacy of the Ohana IVF Sperm Preparation Kit vs. a standard IVF sperm preparation kit.

Condition or disease Intervention/treatment Phase
Infertility Infertility, Male Device: Ohana IVF Sperm Preparation Kit (OHB035) Device: Standard IVF Preparation Kit (OHB037) Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
Other Names:
  • Ohana
  • OHB-035
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.
Other Names:
  • Standard
  • OHB-037


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 37 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: (Sample)

Female Inclusion Criteria:

  1. Premenopausal, age 25-37 years at the time of providing informed consent, who is an appropriate candidate for IVF.
  2. Infertility for ≥ 12 months with regular intercourse with current male partner (or >6 months if age >35).
  3. Regular menses defined as 25 to 35-day cycles or an average of 10-13 spontaneous menstrual periods per year without exogenous hormones.
  4. AMH between 1.8 - 4.9 ng/ml based on screening measurement at central laboratory.
  5. AFC >14 within 3 months of screening visit.

Male Inclusion Criteria:

  1. Willing and able to provide semen specimens at the Screening Visit and on the day of oocyte retrieval; (the specimen provided must be suitable for conventional IVF).
  2. Provide a semen specimen with at least 4 million total motile sperm, following density gradient centrifugation and washing of the sample, at the Screening Visit.

Exclusion Criteria: (Sample)

Female Exclusion Criteria:

  1. Recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
  2. Contraindications to being pregnant or to any of the IVF hormonal modulating medications to be used in this study.
  3. History of severe ovarian hyperstimulation syndrome (OHSS) requiring medical or surgical intervention.
  4. Clinically diagnosed polycystic ovarian syndrome (PCOS.)
  5. Gynecologic history of: pelvic surgery (prior diagnostic or nonoperative laparoscopy, hysteroscopy or operative hysteroscopy are allowed.
  6. Tobacco or nicotine use in the past 12 months.
  7. History of substance abuse, including alcohol abuse.
  8. Abnormal, undiagnosed, vaginal bleeding at the time of screening.

Male Exclusion Criteria:

  1. History of: vasectomy or vasectomy reversal.
  2. Inability and/or unwillingness to provide semen specimens.
  3. Tobacco or nicotine use in the past 12 months.
  4. History of substance abuse, including alcohol abuse.
  5. Marijuana use in the past 12 months.
Contacts and Locations
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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): NCT04142112


Contacts
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Contact: Medical Director 617.674.9242 clinicaltrials@ohanabio.com

Locations
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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
Sponsors and Collaborators
Ohana BioSciences
More Information
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Additional Information:
Study sponsor webpage  This link exits the ClinicalTrials.gov site

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Responsible Party: Ohana BioSciences
ClinicalTrials.gov Identifier: NCT04142112    
Other Study ID Numbers: OHANA-IVF-001
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data collected from this study will be pooled. The study size would not allow for statistical analysis on a site by site level.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female