Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation (SPRING)

September 4, 2020 updated by: Ohana BioSciences

A Randomized, Blinded, Standard-Controlled, Study to Evaluate the Safety and Efficacy of Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit OHB035 on IVF

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

Study Overview

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

Interventional

Enrollment (Anticipated)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tempe, Arizona, United States, 85284
        • Fertility Treatment Center
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Shady Grove Fertility
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Boston IVF Fertility Clinic
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Carolina Conceptions, P.A.
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Fertility Center
    • Texas
      • Bedford, Texas, United States, 76022
        • Center for Assisted Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Three months following last patient treated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Anticipated)

November 26, 2020

Study Completion (Anticipated)

July 26, 2021

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHANA-IVF-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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