Clinical trial NCT06951061: Reproductive Outcomes After Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
Official title: Reproductive Outcomes in Children Born Through Assisted Reproduction (ART): Focus on Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Reproductive Technology, Assisted
IVF Outcomes
ICSI
Keywords: perinatal outcomes
IVF
ICSI
surgically retrieved sperm
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Göteborg University
name: Uppsala University
First posted: 2025-04-30
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemical pregnancy rate
timeFrame: From enrollment to the end of treatment at 3 weeks
measure: Clinical pregnancy rate
timeFrame: From enrollment to the end of treatment at 8 weeks.
measure: Live birth rate
timeFrame: From enrollment to the end of treatment at delivery.
Secondary outcomes:
measure: Number of frozen embryos
timeFrame: From enrollment to the end of treatment at 5 days.
measure: Miscarriage rate
timeFrame: From enrollment to the end of treatment before 22 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Clinical Science, Intervention and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Panagiotis Tsiartas, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: