Reproductive Technology, AssistedSRS-ICSI outcNCT06951061
Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
An observational study of Reproductive Technology, Assisted and IVF Outcomes, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This research project explores how the source of sperm affects outcomes in assisted reproductive technologies (ART), focusing on children conceived through intracytoplasmic sperm injection (ICSI) with surgically retrieved sperm (SRS). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Reproductive Technology, Assisted, IVF Outcomes, ICSI
- What is being tested?
- IVF/ICSI
- Type of treatment
- Surgery or procedure
- How many people
- 200,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2007to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: In this population-based project, data from the National Quality Registry Q-IVF will be employed to identify a birth cohort comprising all IVF treatments performed in Sweden between January 1, 2007, and December 31, 2023. This time frame aligns with the establishment in 2007 of the National Quality Registry for Assisted Reproduction (Q-IVF). This cohort will be followed until December 31, 2023, resulting in a 16-year period.
Who may be able to join
- All IVF treatments performed in Sweden during the study period.
- IVF treatments will be identified from the National register Q-IVF.
Who cannot join
- Children born from multiple pregnancies
- Children conceived through oocyte and sperm donation
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Science, Intervention and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute
Stockholm, 17177
About this study
Official title: Reproductive Outcomes in Children Born Through Assisted Reproduction (ART): Focus on Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
This research project explores how the source of sperm affects outcomes in assisted reproductive technologies (ART), focusing on children conceived through intracytoplasmic sperm injection (ICSI) with surgically retrieved sperm (SRS). Outcomes will be compared to those from ICSI with ejaculated sperm and conventional IVF. Using national registry data from all IVF and ICSI treatments in Sweden between 2007 and 2023 (Q-IVF), the study applies artificial intelligence (AI) and machine learning (ML) to identify factors influencing success rates. The aim is to improve prediction models and support more personalized fertility treatments. Special emphasis is placed on understanding the potential risks and long-term health outcomes for children conceived using SRS, which may be associated with higher rates of genetic abnormalities. The results may help optimize care strategies for infertile couples.
Read the detailed description
This research project aims to improve our understanding of how different sources of sperm affect outcomes in assisted reproductive technologies (ART). The focus is on children conceived through intracytoplasmic sperm injection (ICSI) using surgically retrieved sperm (SRS), compared to ICSI with ejaculated sperm and conventional in vitro fertilization (IVF).
The study has three main goals:
- To compare reproductive outcomes following ICSI with SRS, ICSI with ejaculated sperm, and conventional IVF.
- To investigate whether artificial intelligence (AI) and machine learning (ML) algorithms can predict cumulative reproductive outcomes, including results from both fresh and frozen embryo transfer cycles.
- To evaluate how AI/ML-based models perform in comparison to traditional statistical methods in terms of accuracy and predictive value.
Method: National Population-Based Registry Study: This includes all IVF and ICSI treatments performed in Sweden from January 1, 2007, to December 31, 2023, using data from the Swedish National Quality Registry for Assisted Reproduction (Q-IVF). AI will be used to analyze large datasets, detect patterns, and help identify key factors-such as sperm source, number of retrieved oocytes, and patient characteristics-that may influence treatment success. This approach could lead to personalized treatment plans and better predictions of successful pregnancy outcomes.
Special attention is given to outcomes in children born after ICSI with surgically retrieved sperm, as these sperm may be less mature and carry a higher risk of genetic abnormalities. The findings are expected to provide valuable insights into the reproductive and long-term health outcomes of these treatments, ultimately helping to improve care and treatment strategies for infertile couples.
- Conditions
- Reproductive Technology, Assisted, IVF Outcomes, ICSI
- Being tested
- IVF/ICSI
- Keywords
- perinatal outcomes, IVF, ICSI, surgically retrieved sperm
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF/ICSIProcedure or surgery
In vitro fertilization with or without ICSI with ejaculated and surgically retrieved sperm.
| Study group | Role | What they receive |
|---|---|---|
| IVF with ejaculated sperm | This group have gone through IVF with ejaculated sperm. Both fresh and frozen cycles are included. Receives: Procedure: IVF/ICSI | |
| ICSI with ejaculated sperm | This group have gone through ICSI with ejaculated sperm. Both fresh and frozen cycles are included. Receives: Procedure: IVF/ICSI | |
| ICSI with surgically retrieved sperm | This group have gone through ICSI with surgically retrieved sperm. Both fresh and frozen cycles are included. Receives: Procedure: IVF/ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical pregnancy rate
Positive urinary pregnancy test after fresh or frozen embryo transfer per embryo transfer.
Measured: From enrollment to the end of treatment at 3 weeks
Clinical pregnancy rate
Presence of gestational sac at ultrasound control after fresh or frozen embryo transfer per embryo transfer.
Measured: From enrollment to the end of treatment at 8 weeks.
Live birth rate
Live birth per embryo transfer after fresh and frozen embryo transfer.
Measured: From enrollment to the end of treatment at delivery.
Secondary outcomes (2)
Number of frozen embryos
Number of embryos at blastocyst stage that are frozen.
Measured: From enrollment to the end of treatment at 5 days.
Miscarriage rate
Miscarriage per clinical pregnancy after fresh and frozen embryo transfer.
Measured: From enrollment to the end of treatment before 22 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jan 2007
- Primary completion31 Dec 2023
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive Technology, AssistedStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Uppsala University
- Responsible party
- Principal investigator, Panagiotis Tsiartas, Karolinska Institutet
- Investigators
- Panagiotis Tsiartas, Associate Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951061
- Sponsor's protocol ID
- 2025-00935-01
- Other IDs
- 2025
- Acronym
- SRS-ICSI outc
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the data will be retrieved from Q-IVF in anonymized form, ensuring that no individual can be identified. As such, there is no access to raw, identifiable data, and sharing is restricted to protect patient confidentiality and comply with data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Outcomes in Children Born Through Assisted Reproduction (ART): Focus on Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
- ClinicalTrials.gov ID
- NCT06951061
- Acronym / sponsor ID
- SRS-ICSI outc / 2025-00935-01
- Conditions
- Reproductive Technology, Assisted, IVF Outcomes, ICSI
- Keywords
- perinatal outcomes, IVF, ICSI, surgically retrieved sperm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Göteborg University, Uppsala University
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 30 Apr 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.
This research project explores how the source of sperm affects outcomes in assisted reproductive technologies (ART), focusing on children conceived through intracytoplasmic sperm injection (ICSI) with surgically retrieved sperm (SRS). Outcomes will be compared to those from ICSI with ejaculated sperm and conventional IVF. Using national registry data from all IVF and ICSI treatments in Sweden between 2007 and 2023 (Q-IVF), the study applies artificial intelligence (AI) and machine learning (ML) to identify factors influencing success rates. The aim is to improve prediction models and support more personalized fertility treatments. Special emphasis is placed on understanding the potential risks and long-term health outcomes for children conceived using SRS, which may be associated with higher rates of genetic abnormalities. The results may help optimize care strategies for infertile couples.
Detailed description
This research project aims to improve our understanding of how different sources of sperm affect outcomes in assisted reproductive technologies (ART). The focus is on children conceived through intracytoplasmic sperm injection (ICSI) using surgically retrieved sperm (SRS), compared to ICSI with ejaculated sperm and conventional in vitro fertilization (IVF).
The study has three main goals:
- To compare reproductive outcomes following ICSI with SRS, ICSI with ejaculated sperm, and conventional IVF.
- To investigate whether artificial intelligence (AI) and machine learning (ML) algorithms can predict cumulative reproductive outcomes, including results from both fresh and frozen embryo transfer cycles.
- To evaluate how AI/ML-based models perform in comparison to traditional statistical methods in terms of accuracy and predictive value.
Method: National Population-Based Registry Study: This includes all IVF and ICSI treatments performed in Sweden from January 1, 2007, to December 31, 2023, using data from the Swedish National Quality Registry for Assisted Reproduction (Q-IVF). AI will be used to analyze large datasets, detect patterns, and help identify key factors-such as sperm source, number of retrieved oocytes, and patient characteristics-that may influence treatment success. This approach could lead to personalized treatment plans and better predictions of successful pregnancy outcomes.
Special attention is given to outcomes in children born after ICSI with surgically retrieved sperm, as these sperm may be less mature and carry a higher risk of genetic abnormalities. The findings are expected to provide valuable insights into the reproductive and long-term health outcomes of these treatments, ultimately helping to improve care and treatment strategies for infertile couples.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVF with ejaculated sperm | – | Procedure: IVF/ICSIThis group have gone through IVF with ejaculated sperm. Both fresh and frozen cycles are included. |
| ICSI with ejaculated sperm | – | Procedure: IVF/ICSIThis group have gone through ICSI with ejaculated sperm. Both fresh and frozen cycles are included. |
| ICSI with surgically retrieved sperm | – | Procedure: IVF/ICSIThis group have gone through ICSI with surgically retrieved sperm. Both fresh and frozen cycles are included. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In this population-based project, data from the National Quality Registry Q-IVF will be employed to identify a birth cohort comprising all IVF treatments performed in Sweden between January 1, 2007, and December 31, 2023. This time frame aligns with the establishment in 2007 of the National Quality Registry for Assisted Reproduction (Q-IVF). This cohort will be followed until December 31, 2023, resulting in a 16-year period.
Key inclusion criteria (2 listed)
- All IVF treatments performed in Sweden during the study period.
- IVF treatments will be identified from the National register Q-IVF.
Key exclusion criteria (2 listed)
- Children born from multiple pregnancies
- Children conceived through oocyte and sperm donation
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 |
|---|---|---|
| IVF/ICSIIn vitro fertilization with or without ICSI with ejaculated and surgically retrieved sperm. | Procedure or surgery | ICSI with ejaculated sperm, ICSI with surgically retrieved sperm, IVF with ejaculated sperm |
Primary outcome
Biochemical pregnancy rate
Time frame: From enrollment to the end of treatment at 3 weeks
Positive urinary pregnancy test after fresh or frozen embryo transfer per embryo transfer.
Clinical pregnancy rate
Time frame: From enrollment to the end of treatment at 8 weeks.
Presence of gestational sac at ultrasound control after fresh or frozen embryo transfer per embryo transfer.
Live birth rate
Time frame: From enrollment to the end of treatment at delivery.
Live birth per embryo transfer after fresh and frozen embryo transfer.
2 secondary outcomes
Number of frozen embryos
Time frame: From enrollment to the end of treatment at 5 days.
Miscarriage rate
Time frame: From enrollment to the end of treatment before 22 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because the data will be retrieved from Q-IVF in anonymized form, ensuring that no individual can be identified. As such, there is no access to raw, identifiable data, and sharing is restricted to protect patient confidentiality and comply with data protection regulations.
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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.
Panagiotis Tsiartas, Associate Professor principal investigator
Karolinska Institutet
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 Reproductive Technology, Assisted and IVF Outcomes, run by Karolinska Institutet at 1 site in Sweden.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Biochemical pregnancy rate (time frame: From enrollment to the end of treatment at 3 weeks). The study lists 3 primary outcomes in all. 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 Apr 2025.