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

NCT ID: NCT05680363

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-12-18

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Sperm Preparation

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

Group Type ACTIVE_COMPARATOR

Standard Sperm Preparation

Intervention Type DEVICE

Standard sperm preparation

HyperSperm

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

Group Type EXPERIMENTAL

HyperSperm

Intervention Type DEVICE

Multi-step sperm preparation

Interventions

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HyperSperm

Multi-step sperm preparation

Intervention Type DEVICE

Standard Sperm Preparation

Standard sperm preparation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

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:


* Any diagnosed sexually transmitted infection (STI)
* Total failure of in vitro fertilization in previous cycles.
Minimum Eligible Age

20 Years

Maximum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fecundis S.A.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano Buffone, PhD

Role: PRINCIPAL_INVESTIGATOR

Fecundis Lab SL

Locations

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In Vitro Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Pregna

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

WeFIV

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Fertya

Rosario, Santa Fe Province, Argentina

Site Status

Countries

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Argentina

Other Identifiers

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Fecundis_2

Identifier Type: -

Identifier Source: org_study_id

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