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Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.

Reproductive Outcomes in Children Born Through Assisted Reproduction (ART): Focus on Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06951061
Acronym
SRS-ICSI outc
Enrollment
200000
Registered
2025-04-30
Start date
2007-01-01
Completion date
2027-05-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive Technology, Assisted, IVF Outcomes, ICSI

Keywords

perinatal outcomes, IVF, ICSI, surgically retrieved sperm

Brief 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). 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: 1. To compare reproductive outcomes following ICSI with SRS, ICSI with ejaculated sperm, and conventional IVF. 2. 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. 3. 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.

Interventions

PROCEDUREIVF/ICSI

In vitro fertilization with or without ICSI with ejaculated and surgically retrieved sperm.

Sponsors

Göteborg University
CollaboratorOTHER
Uppsala University
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* All IVF treatments performed in Sweden during the study period. * IVF treatments will be identified from the National register Q-IVF.

Exclusion criteria

* Children born from multiple pregnancies * Children conceived through oocyte and sperm donation

Design outcomes

Primary

MeasureTime frameDescription
Biochemical pregnancy rateFrom enrollment to the end of treatment at 3 weeksPositive urinary pregnancy test after fresh or frozen embryo transfer per embryo transfer.
Clinical pregnancy rateFrom 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 rateFrom enrollment to the end of treatment at delivery.Live birth per embryo transfer after fresh and frozen embryo transfer.

Secondary

MeasureTime frameDescription
Number of frozen embryosFrom enrollment to the end of treatment at 5 days.Number of embryos at blastocyst stage that are frozen.
Miscarriage rateFrom enrollment to the end of treatment before 22 weeks.Miscarriage per clinical pregnancy after fresh and frozen embryo transfer.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026