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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2021-07-26

Brief Summary

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Multi-centered, randomized controlled study, evaluating the safety and efficacy of the Ohana IVF Sperm Preparation Kit vs. a standard IVF sperm preparation kit.

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Detailed Description

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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

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Infertility Infertility, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ohana IVF Sperm Preparation Kit

Samples in the Ohana IVF Sperm Preparation Kit group will undergo product-specific multistep processing in the lab prior to insemination.

Group Type EXPERIMENTAL

Ohana IVF Sperm Preparation Kit (OHB035)

Intervention Type DEVICE

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

Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination.

Group Type ACTIVE_COMPARATOR

Standard IVF Preparation Kit (OHB037)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Ohana OHB-035 Standard OHB-037

Eligibility Criteria

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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.

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

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.

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No