InfertilityNCT05680363
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
A study testing HyperSperm and Standard Sperm Preparation in people with Infertility, run by Fecundis S.A. at 4 sites in Argentina.
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. Read more about this study
- Who is it for?
- Ages 20 to 41 years
- Conditions the study is for
- Infertility
- What is being tested?
- HyperSperm and Standard Sperm Preparation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 4 sitesArgentina
- Study dates
- 1 May 2023to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 41 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Argentina4 sites
In Vitro Buenos Aires
Buenos Aires, Buenos Aires F.D., 1058
Pregna
Buenos Aires, Buenos Aires F.D., 1425
WeFIV
Buenos Aires, Buenos Aires F.D., 1428
Fertya
Rosario, Santa Fe Province, 2282
About this study
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.
- Conditions
- Infertility
- Being tested
- HyperSperm, Standard Sperm Preparation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperSpermDevice
Multi-step sperm preparation
Standard Sperm PreparationDevice
Standard sperm preparation
| Study group | Role | What they receive |
|---|---|---|
| Standard Sperm Preparation | Active comparator | Sperm samples in the control group will undergo traditional processing in the lab prior to insemination. Receives: Device: Standard Sperm Preparation |
| HyperSperm | Experimental | Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. Receives: Device: HyperSperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development rate to blastocysts
Total blastocysts / total fertilized oocytes
Measured: Days 5-6 post insemination
Secondary outcomes (1)
Fertilization rate
Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes
Measured: Day 1 post insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 May 2023
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fecundis S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Buffone, PhD, Principal investigator, Fecundis Lab SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680363
- Sponsor's protocol ID
- Fecundis_2
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oscoz-Susino N, Gomez-Elias MD, Bisioli C, Horton M, Papayannis M, Martino E, Kopcow L, Attie M, Lavolpe M, Carizza C, Luque GM, Graf CB, Monserrat VT, Navall E, Buffone MG, Krapf D. A multicenter, prospective sibling oocyte study revealed that HyperSperm improves the number and quality of embryos in patients undergoing in vitro fertilization. J Transl Med. 2026 Jun 2;24(1):729. doi: 10.1186/s12967-026-08261-4.
PubMed 42231286
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
- ClinicalTrials.gov ID
- NCT05680363
- Acronym / sponsor ID
- Fecundis_2
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Fecundis S.A.University, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Sperm Preparation | Active comparator | Device: Standard Sperm PreparationSperm samples in the control group will undergo traditional processing in the lab prior to insemination. |
| HyperSperm | Experimental | Device: HyperSpermSperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Any diagnosed sexually transmitted infection (STI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperSpermMulti-step sperm preparation | Device | HyperSperm |
| Standard Sperm PreparationStandard sperm preparation | Device | Standard Sperm Preparation |
Primary outcome
Development rate to blastocysts
Time frame: Days 5-6 post insemination
Total blastocysts / total fertilized oocytes
1 secondary outcome
Fertilization rate
Time frame: Day 1 post insemination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Derived from this study: PubMed 42231286Oscoz-Susino N, Gomez-Elias MD, Bisioli C, Horton M, Papayannis M, Martino E, Kopcow L, Attie M, Lavolpe M, Carizza C, Luque GM, Graf CB, Monserrat VT, Navall E, Buffone MG, Krapf D. A multicenter, prospective sibling oocyte study revealed that HyperSperm improves the number and quality of embryos in patients undergoing in vitro fertilization. J Transl Med. 2026 Jun 2;24(1):729. doi: 10.1186/s12967-026-08261-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano Buffone, PhD principal investigator
Fecundis Lab SL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyperSperm and Standard Sperm Preparation in people with Infertility, run by Fecundis S.A. at 4 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development rate to blastocysts (time frame: Days 5-6 post insemination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.