- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04142112
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation (SPRING)
A Randomized, Blinded, Standard-Controlled, Study to Evaluate the Safety and Efficacy of Ohana In-Vitro Fertilization (IVF) Sperm Preparation Kit OHB035 on IVF
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85284
- Fertility Treatment Center
-
-
Florida
-
Clearwater, Florida, United States, 33759
- Women's Medical Research Group, LLC
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Shady Grove Fertility
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02451
- Boston IVF Fertility Clinic
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27607
- Carolina Conceptions, P.A.
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, United States, 19010
- Main Line Fertility Center
-
-
Texas
-
Bedford, Texas, United States, 76022
- Center for Assisted Reproduction
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria: (Sample)
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.
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.
Exclusion Criteria: (Sample)
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
The Ohana IVF Sperm Preparation Kit (OHB035) contains media for processing sperm through a series of timed steps prior to insemination with oocytes.
Other Names:
|
Active Comparator: Standard IVF Preparation Kit
Samples in the Standard IVF Sperm Preparation Kit group will undergo traditional processing in the lab prior to insemination.
|
The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Three months following last patient treated.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHANA-IVF-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey