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

Primary Purpose

Infertility, Infertility, Male

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ohana IVF Sperm Preparation Kit (OHB035)

Standard IVF Preparation Kit (OHB037)

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

25 Years - 37 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fertility Treatment Center
Women's Medical Research Group, LLC
Shady Grove Fertility
Boston IVF Fertility Clinic
Carolina Conceptions, P.A.
Main Line Fertility Center
Center for Assisted Reproduction

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ohana IVF Sperm Preparation Kit

Standard IVF Preparation Kit

Arm Description

Samples in the Ohana IVF Sperm Preparation Kit group will undergo product-specific multistep processing in the lab prior to insemination.

Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination.

Outcomes

Primary Outcome Measures

Blastocyst Evaluation

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04142112

First Posted

October 25, 2019

Last Updated

September 4, 2020

Sponsor

Ohana BioSciences

1. Study Identification

Unique Protocol Identification Number

NCT04142112

Brief Title

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

Acronym

SPRING

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 30, 2019 (Actual)

Primary Completion Date

November 26, 2020 (Anticipated)

Study Completion Date

July 26, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ohana BioSciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Infertility, Male

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ohana IVF Sperm Preparation Kit

Arm Type

Experimental

Arm Description

Samples in the Ohana IVF Sperm Preparation Kit group will undergo product-specific multistep processing in the lab prior to insemination.

Arm Title

Standard IVF Preparation Kit

Arm Type

Active Comparator

Arm Description

Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination.

Intervention Type

Device

Intervention Name(s)

Ohana IVF Sperm Preparation Kit (OHB035)

Other Intervention Name(s)

Ohana, OHB-035

Intervention Description

The Ohana IVF Sperm Preparation Kit (OHB035) contains media for processing sperm through a series of timed steps prior to insemination with oocytes.

Intervention Type

Device

Intervention Name(s)

Standard IVF Preparation Kit (OHB037)

Other Intervention Name(s)

Standard, OHB-037

Intervention Description

The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes.

Primary Outcome Measure Information:

Title

Blastocyst Evaluation

Description

Time Frame

Three months following last patient treated.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Fertility Treatment Center

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85284

Country

United States

Facility Name

Women's Medical Research Group, LLC

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33759

Country

United States

Facility Name

Shady Grove Fertility

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Boston IVF Fertility Clinic

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02451

Country

United States

Facility Name

Carolina Conceptions, P.A.

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Main Line Fertility Center

City

Bryn Mawr

State/Province

Pennsylvania

ZIP/Postal Code

19010

Country

United States

Facility Name

Center for Assisted Reproduction

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Links:

URL

http://ohanabio.com

Description

Study sponsor webpage

Learn more about this trial

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

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