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

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.

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.

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.