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

NCT04142112 | Unknown FDA Device

• 1 other identifier: OHANA-IVF-001
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 7

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.

Conditions

Infertility; Infertility, Male

Outcome Measures

Primary Outcomes (1)

• 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)

  Three months following last patient treated.

Study Arms (2)

Ohana IVF Sperm Preparation Kit

EXPERIMENTAL

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)

Standard IVF Preparation Kit

ACTIVE COMPARATOR

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)

Interventions

Ohana IVF Sperm Preparation Kit (OHB035) DEVICE

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

Also known as: Ohana, OHB-035

Ohana IVF Sperm Preparation Kit

Standard IVF Preparation Kit (OHB037) DEVICE

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

Also known as: Standard, OHB-037

Standard IVF Preparation Kit

Eligibility Criteria

• Age: 25 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ohana BioSciences: lead

Study Sites (7)

Fertility Treatment Center

Tempe, Arizona, 85284, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

Shady Grove Fertility

Rockville, Maryland, 20850, United States

Location

Boston IVF Fertility Clinic

Waltham, Massachusetts, 02451, United States

Location

Carolina Conceptions, P.A.

Raleigh, North Carolina, 27607, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Center for Assisted Reproduction

Bedford, Texas, 76022, United States

Location

Related Links

• Study sponsor webpage

MeSH Terms

Conditions

Infertility; Infertility, Male

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: September 30, 2019
• Primary Completion: November 26, 2020
• Study Completion: July 26, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)