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

Active, not recruiting

• Conditions: Reproductive Technology, Assisted; IVF Outcomes; ICSI

• Registration Number: NCT06951061
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2023-12-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate	From enrollment to the end of treatment at 3 weeks	Positive urinary pregnancy test after fresh or frozen embryo transfer per embryo transfer.
Clinical pregnancy rate	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.
Live birth rate	From enrollment to the end of treatment at delivery.	Live birth per embryo transfer after fresh and frozen embryo transfer.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Clinical Science, Intervention and Technology, Division of Obstetrics and Gynaecology, Karolinska Institute; 🇸🇪 Stockholm, Sweden