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

Fecundis S.A.

Status: Completed

Conditions: Infertility

Treatments: Device: HyperSperm; Device: Standard Sperm Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT05680363

Fecundis_2

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 41 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Standard Sperm Preparation

Active Comparator group

Description:

Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.

Treatment:

Device: Standard Sperm Preparation

HyperSperm

Experimental group

Description:

Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.

Treatment:

Device: HyperSperm