InfertilitySPRINGNCT04142112
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
A study testing Ohana IVF Sperm Preparation Kit (OHB035) and Standard IVF Preparation Kit (OHB037) in people with Infertility and Infertility, Male, run by Ohana BioSciences at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 37 years
- Conditions the study is for
- Infertility, Infertility, Male
- What is being tested?
- Ohana IVF Sperm Preparation Kit (OHB035) and Standard IVF Preparation Kit (OHB037)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Sep 2019to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Center for Assisted Reproduction
Bedford, Texas, 76022
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Carolina Conceptions, P.A.
Raleigh, North Carolina, 27607
Shady Grove Fertility
Rockville, Maryland, 20850
Fertility Treatment Center
Tempe, Arizona, 85284
Boston IVF Fertility Clinic
Waltham, Massachusetts, 02451
About this study
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
Multi-centered, randomized controlled study, evaluating the safety and efficacy of the Ohana IVF Sperm Preparation Kit vs. a standard IVF sperm preparation kit.
Read the 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
- Being tested
- Ohana IVF Sperm Preparation Kit (OHB035), Standard IVF Preparation Kit (OHB037)
- Medical subject headings
- Infertility, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ohana IVF Sperm Preparation Kit (OHB035)Device
Also called Ohana, OHB-035
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)Device
Also called Standard, OHB-037
The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes.
| Study group | Role | What they receive |
|---|---|---|
| Ohana IVF Sperm Preparation Kit | Experimental | Samples in the Ohana IVF Sperm Preparation Kit group will undergo product-specific multistep processing in the lab prior to insemination. Receives: Device: Ohana IVF Sperm Preparation Kit (OHB035) |
| Standard IVF Preparation Kit | Active comparator | Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination. Receives: Device: Standard IVF Preparation Kit (OHB037) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three months following last patient treated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start30 Sep 2019
- Primary completion26 Nov 2020 (estimated)
- Study completion26 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohana BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142112
- Sponsor's protocol ID
- OHANA-IVF-001
- Acronym
- SPRING
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data collected from this study will be pooled. The study size would not allow for statistical analysis on a site by site level.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04142112
- Acronym / sponsor ID
- SPRING / OHANA-IVF-001
- Conditions
- Infertility, Infertility, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Ohana BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 26 Nov 2020 (estimated)
- Study completion
- 26 Jul 2021 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ohana IVF Sperm Preparation Kit | Experimental | Device: Ohana IVF Sperm Preparation Kit (OHB035)Samples in the Ohana IVF Sperm Preparation Kit group will undergo product-specific multistep processing in the lab prior to insemination. |
| Standard IVF Preparation Kit | Active comparator | Device: Standard IVF Preparation Kit (OHB037)Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination. |
Who may qualify
- Ages
- 25 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ohana IVF Sperm Preparation Kit (OHB035)Also: Ohana, OHB-035The Ohana IVF Sperm Preparation Kit (OHB035) contains media for processing sperm through a series of timed steps prior to insemination with oocytes. | Device | Ohana IVF Sperm Preparation Kit |
| Standard IVF Preparation Kit (OHB037)Also: Standard, OHB-037The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes. | Device | Standard IVF Preparation Kit |
Primary outcome
Blastocyst Evaluation
Time frame: Three months following last patient treated.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Study sponsor webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data collected from this study will be pooled. The study size would not allow for statistical analysis on a site by site level.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ohana IVF Sperm Preparation Kit (OHB035) and Standard IVF Preparation Kit (OHB037) in people with Infertility and Infertility, Male, run by Ohana BioSciences at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst Evaluation (time frame: Three months following last patient treated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.