New method to improve embryo development in IVF patients using sibling oocytes
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
NA · Fecundis Lab SL · NCT05680363
This study is testing a new way to prepare sperm for IVF to see if it helps improve embryo development for couples trying to conceive.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 41 Years |
| Sex | All |
| Sponsor | Fecundis Lab SL (other) |
| Locations | 4 sites (Buenos Aires, Caba and 3 other locations) |
| Trial ID | NCT05680363 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new method called HyperSperm for preparing sperm samples in patients undergoing in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). It is a prospective, multi-centric, split-sample study that compares the efficacy and safety of HyperSperm against standard sperm preparation techniques. The study focuses on patients with a specific ovarian reserve and aims to enhance embryo development at the blastocyst stage. Both male and female participants must meet specific inclusion criteria related to age, sperm quality, and reproductive history.
Who should consider this trial
Good fit: Ideal candidates include females with an ovarian reserve of 8 to 30 antral follicles and males aged 20-55 with adequate sperm quality.
Not a fit: Patients with diagnosed sexually transmitted infections, metabolic disorders, or a history of recurrent pregnancy loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved embryo development and higher success rates in IVF and ICSI procedures for patients facing infertility.
How similar studies have performed: While this approach is innovative, similar studies have shown varying degrees of success in improving IVF outcomes, making this a potentially promising but novel investigation.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Buenos Aires, Caba and 3 other locations
- In Vitro Buenos Aires — Buenos Aires, Caba, Argentina (RECRUITING)
- Pregna — Buenos Aires, Caba, Argentina (RECRUITING)
- WeFIV — Buenos Aires, Caba, Argentina (RECRUITING)
- Fertya — Rosario, Santa Fe, Argentina (RECRUITING)
Study contacts
- Principal investigator: Mariano Buffone, PhD — Fecundis Lab SL
- Study coordinator: Mariano Buffone, PhD
- Email: buffone@fecundis.com
- Phone: +54114783 2869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility