Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243913
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-25
Brief Title:
A Pilot Study Analyzing Reproductive Results After IUI Using Vitrified Human Sperm
Sponsor:
Clínica EUGIN
Organization:
Clínica EUGIN
Study Overview
Official Title:
Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination With Donor Sperm Previously Vitrified - Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOKIBANK
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 -20000 ºCmin 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
Sperm vitrification has been recently developed as an improved alternative where freezing occurs extremely rapidly -20000 ºCmin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None