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

NCT ID: NCT06951061

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2027-05-30

Brief Summary

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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

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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.

Conditions

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Reproductive Technology, Assisted IVF Outcomes ICSI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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IVF with ejaculated sperm

This group have gone through IVF with ejaculated sperm. Both fresh and frozen cycles are included.

IVF/ICSI

Intervention Type PROCEDURE

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

ICSI with ejaculated sperm

This group have gone through ICSI with ejaculated sperm. Both fresh and frozen cycles are included.

IVF/ICSI

Intervention Type PROCEDURE

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

ICSI with surgically retrieved sperm

This group have gone through ICSI with surgically retrieved sperm. Both fresh and frozen cycles are included.

IVF/ICSI

Intervention Type PROCEDURE

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

Interventions

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IVF/ICSI

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Panagiotis Tsiartas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panagiotis Tsiartas, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Department of Clinical Science, Intervention and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2025-00935-01

Identifier Type: -

Identifier Source: org_study_id

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