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NCT Number: NCT06951061

Reproductive Outcomes After 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.

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Key information

Conditions

Reproductive Technology, Assisted Behavior Helping Behavior ICSI IVF Outcomes Social Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Stockholm, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVF/ICSI

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. Miscarriage rate

    Time frame: From enrollment to the end of treatment before 22 weeks.

    Miscarriage per clinical pregnancy after fresh and frozen embryo transfer.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Göteborg University
  • Uppsala University

Registry information

Official study title

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

Acronym: SRS-ICSI outc

Important dates

Study start
2007
Primary completion
2023
Study completion
2027
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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