Infertility
Conditions
Keywords
intrauterine insemination, sperm cryopreservation, sperm vitrification
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.
Interventions
PROCEDUREIUI 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.
Sponsors
Clínica EUGIN
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 7 weeks after procedure | Fetal heartbeat observed in the 7th week of gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of sperm progressive motility | Day of procedure | Percentage of sperm progressive motility (% a+b) after thawing |
| Total number of sperm with progressive motility | Day of procedure | Total number of sperm with progressive motility after thawing |
| Biochemical pregnancy rate | 14 days after procedure | Positive pregnancy test |
Countries
Spain
Outcome results
None listed