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

Not Applicable

Recruiting

• Conditions: Infertility
• Interventions: Device: Standard Sperm Preparation; Device: HyperSperm

• Registration Number: NCT05680363
• Lead Sponsor: Fecundis S.A.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-11
• Study Start: 2023-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Sperm Preparation	Standard Sperm Preparation	Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
HyperSperm	HyperSperm	Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.

Primary Outcome Measures

Name	Time	Method
Development rate to blastocysts	Days 5-6 post insemination	Total blastocysts / total fertilized oocytes

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	Day 1 post insemination	Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes

Trial Locations

Locations (4)

In Vitro Buenos Aires; 🇦🇷 Buenos Aires, Caba, Argentina

WeFIV; 🇦🇷 Buenos Aires, Caba, Argentina

Pregna; 🇦🇷 Buenos Aires, Caba, Argentina

Fertya; 🇦🇷 Rosario, Santa Fe, Argentina