NCT04142112

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Ohana BioSciences · Industry
• Sex: All
• Age: 25 Years – 37 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility
• Infertility, Male

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2020-11-26
• Completion: 2021-07-26
• First posted: 2019-10-29
• Last updated: 2020-09-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study