Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation (SPRING)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04142112 |
Recruitment Status :
Active, not recruiting
First Posted : October 29, 2019
Last Update Posted : September 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 : | November 26, 2020 |
Estimated Study Completion Date : | July 26, 2021 |

Arm | Intervention/treatment |
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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.
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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:
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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.
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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:
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- 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)

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Ages Eligible for Study: | 25 Years to 37 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria: (Sample)
Female Inclusion Criteria:
- Premenopausal, age 25-37 years at the time of providing informed consent, who is an appropriate candidate for IVF.
- Infertility for ≥ 12 months with regular intercourse with current male partner (or >6 months if age >35).
- Regular menses defined as 25 to 35-day cycles or an average of 10-13 spontaneous menstrual periods per year without exogenous hormones.
- AMH between 1.8 - 4.9 ng/ml based on screening measurement at central laboratory.
- AFC >14 within 3 months of screening visit.
Male Inclusion Criteria:
- 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).
- 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:
- Recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
- Contraindications to being pregnant or to any of the IVF hormonal modulating medications to be used in this study.
- History of severe ovarian hyperstimulation syndrome (OHSS) requiring medical or surgical intervention.
- Clinically diagnosed polycystic ovarian syndrome (PCOS.)
- Gynecologic history of: pelvic surgery (prior diagnostic or nonoperative laparoscopy, hysteroscopy or operative hysteroscopy are allowed.
- Tobacco or nicotine use in the past 12 months.
- History of substance abuse, including alcohol abuse.
- Abnormal, undiagnosed, vaginal bleeding at the time of screening.
Male Exclusion Criteria:
- History of: vasectomy or vasectomy reversal.
- Inability and/or unwillingness to provide semen specimens.
- Tobacco or nicotine use in the past 12 months.
- History of substance abuse, including alcohol abuse.
- Marijuana use in the past 12 months.

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
United States, Arizona | |
Fertility Treatment Center | |
Tempe, Arizona, United States, 85284 | |
United States, Florida | |
Women's Medical Research Group, LLC | |
Clearwater, Florida, United States, 33759 | |
United States, Maryland | |
Shady Grove Fertility | |
Rockville, Maryland, United States, 20850 | |
United States, Massachusetts | |
Boston IVF Fertility Clinic | |
Waltham, Massachusetts, United States, 02451 | |
United States, North Carolina | |
Carolina Conceptions, P.A. | |
Raleigh, North Carolina, United States, 27607 | |
United States, Pennsylvania | |
Main Line Fertility Center | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
United States, Texas | |
Center for Assisted Reproduction | |
Bedford, Texas, United States, 76022 |
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: | September 9, 2020 |
Last Verified: | September 2020 |
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. |
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 |
Infertility Infertility, Male |