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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 41
Healthy Volunteers: f
View:

• With ovarian reserve of between 8 and 30 antral follicles counting both ovaries

• Treatment planned for embryo transfer at the blastocyst stage

• 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

• 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

Locations
Other Locations
Argentina
In Vitro Buenos Aires
RECRUITING
Buenos Aires
Pregna
RECRUITING
Buenos Aires
WeFIV
RECRUITING
Buenos Aires
Fertya
RECRUITING
Rosario
Contact Information
Primary
Mariano Buffone, PhD
buffone@fecundis.com
+54114783 2869
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 40
Treatments
Active_comparator: Standard Sperm Preparation
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
Experimental: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
Related Therapeutic Areas
Sponsors
Leads: Fecundis S.A.

This content was sourced from clinicaltrials.gov