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

NCT06951061 | Active Not Recruiting

• 1 other identifier: 2025-00935-01
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Technology, Assisted; IVF Outcomes; ICSI

Keywords

perinatal outcomes; IVF; ICSI; surgically retrieved sperm

Outcome Measures

Primary Outcomes (3)

• Biochemical pregnancy rate

  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

  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

  Live birth per embryo transfer after fresh and frozen embryo transfer.

  From enrollment to the end of treatment at delivery.

Secondary Outcomes (2)

• Number of frozen embryos

  From enrollment to the end of treatment at 5 days.

• Miscarriage rate

  From enrollment to the end of treatment before 22 weeks.

Study Arms (3)

IVF with ejaculated sperm

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

Procedure: IVF/ICSI

ICSI with ejaculated sperm

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

Procedure: IVF/ICSI

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

Interventions

IVF/ICSI PROCEDURE

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

ICSI with ejaculated sperm; ICSI with surgically retrieved sperm; IVF with ejaculated sperm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• All IVF treatments performed in Sweden during the study period.
• IVF treatments will be identified from the National register Q-IVF.

You may not qualify if:

• Children born from multiple pregnancies
• Children conceived through oocyte and sperm donation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Göteborg University: collaborator
• Uppsala University: collaborator

Study Sites (1)

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

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Helping Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Panagiotis Tsiartas, Associate Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 30, 2025
• Study Start: January 1, 2007
• Primary Completion: December 31, 2023
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)