A Pilot Study Analyzing Reproductive Results After IUI Using Vitrified Human Sperm

Completed

• Conditions: Infertility

• Registration Number: NCT06243913
• Lead Sponsor: Clínica EUGIN

Brief Summary

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments.

Detailed Description

Sperm cryopreservation is an efficient procedure widely used in fertility clinics, that provides logistical flexibility and increases the potential for success in assisted reproduction. It has been demonstrated that reproductive rates are comparable when using frozen sperm or fresh semen. However, sperm freezing using standard protocols is inevitably associated with a loss of motility, membrane integrity, and other post-thaw sperm quality parameters due to what is known as cryodamage, which involves the formation of intracellular ice crystals, osmotic shock, and dehydration.

Sperm vitrification has been recently developed as an improved alternative, where freezing occurs extremely rapidly (-20,000 ºC/min). Consequently, the formation of intracellular ice crystals is reduced, leading to improvements in sperm motility, vitality, and integrity.

However, the use of vitrified semen in fertility clinics is scarce, and no study has addressed whether vitrification could affect reproductive outcomes, such as live birth.

The aim of this study is to assess the evaluate the effectiveness of vitrified donor semen in intrauterine insemination treatments through the analysis of clinical pregnancy (primary objective) and as secondary objectives the number of progressive sperm post-thaw, percentage of progressive sperm and biochemical pregnancy.

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-06
• Status Verified: 2024-12
• Primary Completion: 2024-12-13
• Study Completion: 2024-12-13
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients undergoing Artificial Insemination with sperm from donor.
• Female partner's age < 35 years
• First IUI attempt
• Caucasian phenotype

Exclusion Criteria

• Any adverse medical condition that may significantly affect reproductive outcomes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	7 weeks after procedure	Fetal heartbeat observed in the 7th week of gestation.

Secondary Outcome Measures

Name	Time	Method
Percentage of sperm progressive motility	Day of procedure	Percentage of sperm progressive motility (% a+b) after thawing
Biochemical pregnancy rate	14 days after procedure	Positive pregnancy test
Total number of sperm with progressive motility	Day of procedure	Total number of sperm with progressive motility after thawing

Trial Locations

Locations (1)

Clinica EUGIN; 🇪🇸 Barcelona, Spain