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

April 22, 2025 updated by: Panagiotis Tsiartas, Karolinska Institutet

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Department of Clinical Science, Intervention and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IVF with ejaculated sperm
This group have gone through IVF with ejaculated sperm. Both fresh and frozen cycles are included.
Procedure: IVF/ICSI
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.
Procedure: IVF/ICSI
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.
Procedure: IVF/ICSI
In vitro fertilization with or without ICSI with ejaculated and surgically retrieved sperm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 3 weeks
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.
From enrollment to the end of treatment at 8 weeks.
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.
From enrollment to the end of treatment at delivery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of frozen embryos
Time Frame: From enrollment to the end of treatment at 5 days.
Number of embryos at blastocyst stage that are frozen.
From enrollment to the end of treatment at 5 days.
Miscarriage rate
Time Frame: From enrollment to the end of treatment before 22 weeks.
Miscarriage per clinical pregnancy after fresh and frozen embryo transfer.
From enrollment to the end of treatment before 22 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Uppsala University
Göteborg University

Investigators

  • Principal Investigator: Panagiotis Tsiartas, Associate Professor, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-00935-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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