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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility, Infertility, Male

Intervention / Treatment
-----------------
* Device: Ohana IVF Sperm Preparation Kit (OHB035)
* Device: Standard IVF Preparation Kit (OHB037)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 37 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ohana IVF Sperm Preparation Kit<br>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)<br>* The Ohana IVF Sperm Preparation Kit (OHB035) contains media for processing sperm through a series of timed steps prior to insemination with oocytes.<br>* Other names: OHB-035;|
| Active Comparator: Standard IVF Preparation Kit<br>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)<br>* The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes.<br>* Other names: OHB-037;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |