InfertilityBIOKIBANKNCT06243913
A Pilot Study Analyzing Reproductive Results After IUI Using Vitrified Human Sperm
An observational study of Infertility, run by Clínica EUGIN at 1 site in Spain.
Trial summary
The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Infertility
- What is being tested?
- IUI with vitrified sperm from donor:
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2022to 13 Dec 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: ART couples where the female partner is under 35 years old who are undergoing their first attempt of intrauterine artificial insemination with donor semen
Who may be able to join
- Patients undergoing Artificial Insemination with sperm from donor.
- Female partner's age < 35 years
- First IUI attempt
- Caucasian phenotype
Who cannot join
- Any adverse medical condition that may significantly affect reproductive outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination with Donor Sperm Previously Vitrified - Pilot Study
The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments.
Read the detailed description
Sperm cryopreservation is an efficient procedure widely used in fertility clinics, that provides logistical flexibility and increases the potential for success in assisted reproduction. It has been demonstrated that reproductive rates are comparable when using frozen sperm or fresh semen. However, sperm freezing using standard protocols is inevitably associated with a loss of motility, membrane integrity, and other post-thaw sperm quality parameters due to what is known as cryodamage, which involves the formation of intracellular ice crystals, osmotic shock, and dehydration.
Sperm vitrification has been recently developed as an improved alternative, where freezing occurs extremely rapidly (-20,000 ºC/min). Consequently, the formation of intracellular ice crystals is reduced, leading to improvements in sperm motility, vitality, and integrity.
However, the use of vitrified semen in fertility clinics is scarce, and no study has addressed whether vitrification could affect reproductive outcomes, such as live birth.
The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments through the analysis of clinical pregnancy (primary objective) and as secondary objectives the number of progressive sperm post-thaw, percentage of progressive sperm and biochemical pregnancy.
- Conditions
- Infertility
- Being tested
- IUI with vitrified sperm from donor:
- Keywords
- intrauterine insemination, sperm cryopreservation, sperm vitrification
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUI with vitrified sperm from donor:Procedure or surgery
After signing the informed consent, the clinic's Matching team will assign a donor semen straw based on phenotypic characteristics, blood group, and genetic compatibility (if applicable), with the female partner.
On the day of the Intrauterine Insemination (IUI), the laboratory team will thaw the assigned donor semen straw and post-thaw sperm parameters will be analyzed, including the total number of sperm with progressive motility. Subsequently, the IUI will be performed following the standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Use of vitrified donor semen for Intrauterine Artificial Insemination Receives: Procedure: IUI with vitrified sperm from donor: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Fetal heartbeat observed in the 7th week of gestation.
Measured: 7 weeks after procedure
Secondary outcomes (3)
Percentage of sperm progressive motility
Percentage of sperm progressive motility (% a+b) after thawing
Measured: Day of procedure
Total number of sperm with progressive motility
Total number of sperm with progressive motility after thawing
Measured: Day of procedure
Biochemical pregnancy rate
Positive pregnancy test
Measured: 14 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start20 Dec 2022
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica EUGIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Torra-Massana, PhD, Principal investigator, Clinica EUGIN, Barcelona (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243913
- Sponsor's protocol ID
- BIOKIBANK
- Acronym
- BIOKIBANK
- Status last verified
- Dec 2024
- First submitted
- 25 Jan 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination with Donor Sperm Previously Vitrified - Pilot Study
- ClinicalTrials.gov ID
- NCT06243913
- Acronym / sponsor ID
- BIOKIBANK / BIOKIBANK
- Conditions
- Infertility
- Keywords
- intrauterine insemination, sperm cryopreservation, sperm vitrification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clínica EUGINUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 6 Feb 2024 (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.
The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments.
Detailed description
Sperm cryopreservation is an efficient procedure widely used in fertility clinics, that provides logistical flexibility and increases the potential for success in assisted reproduction. It has been demonstrated that reproductive rates are comparable when using frozen sperm or fresh semen. However, sperm freezing using standard protocols is inevitably associated with a loss of motility, membrane integrity, and other post-thaw sperm quality parameters due to what is known as cryodamage, which involves the formation of intracellular ice crystals, osmotic shock, and dehydration.
Sperm vitrification has been recently developed as an improved alternative, where freezing occurs extremely rapidly (-20,000 ºC/min). Consequently, the formation of intracellular ice crystals is reduced, leading to improvements in sperm motility, vitality, and integrity.
However, the use of vitrified semen in fertility clinics is scarce, and no study has addressed whether vitrification could affect reproductive outcomes, such as live birth.
The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments through the analysis of clinical pregnancy (primary objective) and as secondary objectives the number of progressive sperm post-thaw, percentage of progressive sperm and biochemical pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | – | Procedure: IUI with vitrified sperm from donor:Use of vitrified donor semen for Intrauterine Artificial Insemination |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ART couples where the female partner is under 35 years old who are undergoing their first attempt of intrauterine artificial insemination with donor semen
Key inclusion criteria (4 listed)
- Patients undergoing Artificial Insemination with sperm from donor.
- Female partner's age < 35 years
- First IUI attempt
- Caucasian phenotype
Key exclusion criteria (1 listed)
- Any adverse medical condition that may significantly affect reproductive outcomes
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 |
|---|---|---|
| IUI with vitrified sperm from donor:After signing the informed consent, the clinic's Matching team will assign a donor semen straw based on phenotypic characteristics, blood group, and genetic compatibility (if applicable), with the female partner. On the day of the Intrauterine Insemination (IUI), the laboratory team will thaw the assigned donor semen straw and post-thaw sperm parameters will be analyzed, including the total number of sperm with progressive motility. Subsequently, the IUI will be performed following the standard protocol. | Procedure or surgery | Intervention arm |
Primary outcome
Clinical pregnancy rate
Time frame: 7 weeks after procedure
Fetal heartbeat observed in the 7th week of gestation.
3 secondary outcomes
Percentage of sperm progressive motility
Time frame: Day of procedure
Total number of sperm with progressive motility
Time frame: Day of procedure
Biochemical pregnancy rate
Time frame: 14 days after procedure
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 18 Dec 2024.
- 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.
Marc Torra-Massana, PhD principal investigator
Clinica EUGIN, Barcelona (Spain)
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 Infertility, run by Clínica EUGIN at 1 site in Spain.
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 4 inclusion and 1 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 18 Dec 2024. 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 Spain. 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?
Clinical pregnancy rate (time frame: 7 weeks after procedure). 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 18 Dec 2024.