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NCT05680363 Clinical Trial

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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05680363
Other study ID # Fecundis_2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date December 2023

Study information
Verified date August 2023
Source Fecundis S.A.
Contact Mariano Buffone, PhD
Phone +54 11 4783 2869
Email buffone@fecundis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 41 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HyperSperm
Multi-step sperm preparation
• Standard Sperm Preparation
Standard sperm preparation

Locations
Country Name City State
Argentina In Vitro Buenos Aires Buenos Aires Caba
Argentina Pregna Buenos Aires Caba
Argentina WeFIV Buenos Aires Caba
Argentina Fertya Rosario Santa Fe

Sponsors (1)
Lead Sponsor Collaborator
Fecundis S.A.

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development rate to blastocysts Total blastocysts / total fertilized oocytes Days 5-6 post insemination
Secondary Fertilization rate Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes Day 1 post insemination
See also
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Terminated NCT03522350 - Randomized Trial Comparing EmbryoScope With EmbryoScope+. N/A
Completed NCT04496284 - Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen N/A
Completed NCT03623659 - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts N/A
Completed NCT03895099 - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors Phase 3
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Completed NCT03152643 - Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer N/A
Recruiting NCT03683771 - Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Recruiting NCT03161119 - Comparing Two Different Embryo Transfer Catheters N/A
Completed NCT04108039 - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. N/A
Completed NCT03677492 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD) N/A
Completed NCT03678584 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA) N/A
Completed NCT03678571 - Oocyte Vitrification Aided With Latrunculin A N/A
Completed NCT03678610 - Handling Medium for ICSI With Ionomycin and Latrunculin A N/A
Completed NCT03678597 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB) N/A
Completed NCT03678818 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA) N/A
Completed NCT03678558 - Oocyte Vitrification Aided With Cytochalasin B N/A