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

Primary Purpose

Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
HyperSperm
Standard Sperm Preparation
Sponsored by
Fecundis S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 41 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • In Vitro Buenos AiresRecruiting
  • PregnaRecruiting
  • WeFIVRecruiting
  • FertyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Sperm Preparation

HyperSperm

Arm Description

Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.

Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.

Outcomes

Primary Outcome Measures

Development rate to blastocysts
Total blastocysts / total fertilized oocytes

Secondary Outcome Measures

Fertilization rate
Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes

Full Information

First Posted
December 6, 2022
Last Updated
August 18, 2023
Sponsor
Fecundis S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05680363
Brief Title
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Official Title
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fecundis S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Sperm Preparation
Arm Type
Active Comparator
Arm Description
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
Arm Title
HyperSperm
Arm Type
Experimental
Arm Description
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
Intervention Type
Device
Intervention Name(s)
HyperSperm
Intervention Description
Multi-step sperm preparation
Intervention Type
Device
Intervention Name(s)
Standard Sperm Preparation
Intervention Description
Standard sperm preparation
Primary Outcome Measure Information:
Title
Development rate to blastocysts
Description
Total blastocysts / total fertilized oocytes
Time Frame
Days 5-6 post insemination
Secondary Outcome Measure Information:
Title
Fertilization rate
Description
Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes
Time Frame
Day 1 post insemination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariano Buffone, PhD
Phone
+54 11 4783 2869
Ext
1314
Email
buffone@fecundis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Buffone, PhD
Organizational Affiliation
Fecundis S.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
In Vitro Buenos Aires
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1058
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Attie, MD
Phone
+54 11 2152 6400
Email
martinattie@invitro.com.ar
Facility Name
Pregna
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Horton, MD
Phone
+54 11 4834 1600
Email
mhorton@pregna.com.ar
Facility Name
WeFIV
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
1428
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Almoño, MD
Phone
+54 11 4789 3600
Email
lucasalmono@intramed.net
Facility Name
Fertya
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2282
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Carizza, MD
Phone
+54 341 525 2005
Email
ccarizza@fertya.com.ar

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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