Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients

Study Overview
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Brief Summary
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Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.

Official Title
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Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients

Conditions
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Infertility

Intervention / Treatment
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* Device: HyperSperm
* Device: Standard Sperm Preparation


Participation Criteria
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Eligibility Criteria
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Female: Inclusion Criteria: With ovarian reserve of between 8 and 30 antral follicles counting both ovaries Treatment planned for embryo transfer at the blastocyst stage Exclusion Criteria: Any diagnosed sexually transmitted infection (STI) Diabetes or other metabolic disorders. Recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth). Previous failures in two or more IVF cycles Male: Inclusion Criteria for IVF: Age: 20-55 years Fresh sample (not cryopreserved ) Sperm motility (TOTAL) ≥ 40% in spermogram Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram Sperm count after swim up ≥ 5x10^6 Treatment planned for embryo transfer at the blastocyst stage Inclusion Criteria for ICSI: Age: 20-55 years Fresh sample (not cryopreserved ) Sperm concentration ≥ 10x10^6 /ml in spermogram Sperm motility (TOTAL) ≥ 20% in spermogram Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram Treatment planned for embryo transfer at the blastocyst stage Exclusion Criteria: Any diagnosed sexually transmitted infection (STI) Total failure of in vitro fertilization in previous cycles.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Sperm Preparation<br>Sperm samples in the control group will undergo traditional processing in the lab prior to insemination. | Device: Standard Sperm Preparation<br>* Standard sperm preparation<br>|
| Experimental: HyperSperm<br>Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. | Device: HyperSperm<br>* Multi-step sperm preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development rate to blastocysts | Total blastocysts / total fertilized oocytes | Days 5-6 post insemination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes | Day 1 post insemination |