Spermatozoa, AbnormalNCT06801652
The Influence of Sperm Morphology and Functional Indices on Blastocyst Development in Assisted Reproduction
An observational study of Spermatozoa, Abnormal and in Vitro Fertilization, run by Calla IVF Center at 1 site in Romania.
Trial summary
Samples from male partners of 120 infertile couples undergoing IVF were analyzed. Sperm morphology was assessed using the SpermBlue staining method, while TZI, MAI, and SDI were calculated. Embryo development was monitored until day 5 or 6. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Spermatozoa, Abnormal, in Vitro Fertilization, Blastocyst
- What is being tested?
- Sperm morphology indexes
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- 21 Oct 2023to 10 Nov 2024
- Phase
- Observational
- 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 21 to 40 years
- All sexes
- Adult
Study population: This prospective observational study analyzed sperm and embryonic parameters from 120 IVF cycles over 18 months. Functional sperm indices and embryo outcomes were evaluated to determine their relationship.
Who may be able to join
- couples with an infertility diagnosis that underwent an IVF procedure and had obtained at least one blastocyst
Who cannot join
- donors
- uterine abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Samples from male partners of 120 infertile couples undergoing IVF were analyzed. Sperm morphology was assessed using the SpermBlue staining method, while TZI, MAI, and SDI were calculated. Embryo development was monitored until day 5 or 6. Statistical analyses included regression models and correlation coefficients to evaluate the predictive value of sperm indices on blastocyst development.
Read the detailed description
For spermatozoa selection we used ZyMot multi in all patients undergoing IVF. After intracytoplasmatic injection of spermatozoa we asses the blastocyst grading in day 5. NEQSI score meaning numerical embryonic quality score index was used for statistical purpose. The spermatozoa morphology indexes were: TZI (teratozoospermia index), MAI (multiple anomalies index), SDI (sperm deformity index) and analyzed with CASA analyzer. All these indexes were assessed in patients and correlated in all groups: patients that had a positive pregnancy test, patients that had a negative pregnancy rate, patients that had no blastocyst in day 5 and patients that had all aneuploid embyos.
- Conditions
- Spermatozoa, Abnormal, in Vitro Fertilization, Blastocyst, Aneuploidy
- Being tested
- Sperm morphology indexes
- Medical subject headings
- Teratozoospermia, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm morphology indexesOther
We analyzed all sperm morphology indexes in all groups.
| Study group | Role | What they receive |
|---|---|---|
| Positive HCG pregnancy test after embryotransfer | Patients with sperm morphology indexes analyzed and had at least one good quality blastocyst that had a Positive HCG pregnancy test after embryo-transfer. Receives: Other: Sperm morphology indexes | |
| Negative HCG pregnancy test after embryotransfer | Patients with sperm morphology indexes analyzed and had at least one good quality blastocyst that had a Negative HCG pregnancy test after embryo-transfer. Receives: Other: Sperm morphology indexes | |
| No embryo obtained after IVF | Patients with sperm morphology indexes analyzed and had no blastocyst in day 5 or 6 after ICSI-IVF. Receives: Other: Sperm morphology indexes | |
| All embryos obtained are aneuploid | Patients with sperm morphology indexes analyzed and had all blastocyst of day 5/6 tested and aneuployd after ICSI-IVF. Receives: Other: Sperm morphology indexes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sperm morphology indices on fertilization and blastulation rate
Functional sperm indices and embryo outcomes were evaluated to determine their relationship.
Measured: 18 months
Secondary outcomes (1)
Evaluation of sperm morphology indices on IVF outcomes
The study's findings are limited to IVF populations and may not generalize to natural conception.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start21 Oct 2023
- Primary completion23 Oct 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spermatozoa, AbnormalStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calla IVF Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801652
- Sponsor's protocol ID
- CALLA TERATOZOOSPERMIA
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sperm Morphology and Functional Indices on Blastocyst Development in Assisted Reproduction
- ClinicalTrials.gov ID
- NCT06801652
- Acronym / sponsor ID
- CALLA TERATOZOOSPERMIA
- Conditions
- Spermatozoa, Abnormal, in Vitro Fertilization, Blastocyst, Aneuploidy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Calla IVF CenterUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 30 Jan 2025 (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.
Samples from male partners of 120 infertile couples undergoing IVF were analyzed. Sperm morphology was assessed using the SpermBlue staining method, while TZI, MAI, and SDI were calculated. Embryo development was monitored until day 5 or 6. Statistical analyses included regression models and correlation coefficients to evaluate the predictive value of sperm indices on blastocyst development.
Detailed description
For spermatozoa selection we used ZyMot multi in all patients undergoing IVF. After intracytoplasmatic injection of spermatozoa we asses the blastocyst grading in day 5. NEQSI score meaning numerical embryonic quality score index was used for statistical purpose. The spermatozoa morphology indexes were: TZI (teratozoospermia index), MAI (multiple anomalies index), SDI (sperm deformity index) and analyzed with CASA analyzer. All these indexes were assessed in patients and correlated in all groups: patients that had a positive pregnancy test, patients that had a negative pregnancy rate, patients that had no blastocyst in day 5 and patients that had all aneuploid embyos.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive HCG pregnancy test after embryotransfer | – | Other: Sperm morphology indexesPatients with sperm morphology indexes analyzed and had at least one good quality blastocyst that had a Positive HCG pregnancy test after embryo-transfer. |
| Negative HCG pregnancy test after embryotransfer | – | Other: Sperm morphology indexesPatients with sperm morphology indexes analyzed and had at least one good quality blastocyst that had a Negative HCG pregnancy test after embryo-transfer. |
| No embryo obtained after IVF | – | Other: Sperm morphology indexesPatients with sperm morphology indexes analyzed and had no blastocyst in day 5 or 6 after ICSI-IVF. |
| All embryos obtained are aneuploid | – | Other: Sperm morphology indexesPatients with sperm morphology indexes analyzed and had all blastocyst of day 5/6 tested and aneuployd after ICSI-IVF. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- This prospective observational study analyzed sperm and embryonic parameters from 120 IVF cycles over 18 months. Functional sperm indices and embryo outcomes were evaluated to determine their relationship.
Key inclusion criteria (1 listed)
- couples with an infertility diagnosis that underwent an IVF procedure and had obtained at least one blastocyst
Key exclusion criteria (2 listed)
- donors
- uterine abnormalities
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 |
|---|---|---|
| Sperm morphology indexesWe analyzed all sperm morphology indexes in all groups. | Other | All embryos obtained are aneuploid, Negative HCG pregnancy test after embryotransfer, No embryo obtained after IVF, Positive HCG pregnancy test after embryotransfer |
Primary outcome
Evaluation of sperm morphology indices on fertilization and blastulation rate
Time frame: 18 months
Functional sperm indices and embryo outcomes were evaluated to determine their relationship.
1 secondary outcome
Evaluation of sperm morphology indices on IVF outcomes
Time frame: 16 months
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 30 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spermatozoa, Abnormal and in Vitro Fertilization, run by Calla IVF Center at 1 site in Romania.
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 1 inclusion and 2 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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?
Evaluation of sperm morphology indices on fertilization and blastulation rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.