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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
Sponsor:
Information provided by (Responsible Party):
Ohana BioSciences

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Standard-Controlled, Study to Evaluate the Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit
Official Title  ICMJE A Randomized, Blinded, Standard-Controlled, Study to Evaluate the Safety and Efficacy of Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit OHB035 on IVF
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility
  • Infertility, Male
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Ohana IVF Sperm Preparation Kit (OHB035)
  • 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.
    Intervention: Device: Standard IVF Preparation Kit (OHB037)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2019)
83
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 26, 2021
Estimated Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical Director 617.674.9242 clinicaltrials@ohanabio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04142112
Other Study ID Numbers  ICMJE OHANA-IVF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Ohana BioSciences
Study Sponsor  ICMJE Ohana BioSciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ohana BioSciences
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP