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

Infertility Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04142112
• Other study ID #: OHANA-IVF-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: July 26, 2021

Study information

• Verified date: September 2020
• Source: Ohana BioSciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: July 26, 2021
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Assisted Reproduction	Bedford	Texas
United States	Main Line Fertility Center	Bryn Mawr	Pennsylvania
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Carolina Conceptions, P.A.	Raleigh	North Carolina
United States	Shady Grove Fertility	Rockville	Maryland
United States	Fertility Treatment Center	Tempe	Arizona
United States	Boston IVF Fertility Clinic	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ohana BioSciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Study sponsor webpage