NCT06243913

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

Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination with Donor Sperm Previously Vitrified - Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Clínica EUGIN · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
PROCEDURE	IUI with vitrified sperm from donor:	After signing the informed consent, the clinic's Matching team will assign a donor semen straw based on phenotypic characteristics, blood group, and genetic compatibility (if applicable), with the female partner. On the day of the Intrauterine Insemination (IUI), the laboratory team will thaw the assigned donor semen straw and post-thaw sperm parameters will be analyzed, including the total number of sperm with progressive motility. Subsequently, the IUI will be performed following the standard protocol.

Timeline

• Start date: 2022-12-20
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2024-02-06
• Last updated: 2024-12-18

Locations

1 site across 1 country: Spain