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

Not Applicable

Recruiting

• Conditions: Infertility

• 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

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

Pregna; 🇦🇷 Buenos Aires, Caba, Argentina

WeFIV; 🇦🇷 Buenos Aires, Caba, Argentina

Fertya; 🇦🇷 Rosario, Santa Fe, Argentina