Clinical trial NCT06243913: A Pilot Study Analyzing Reproductive Results After IUI Using Vitrified Human Sperm
Official title: Analysis of Reproductive Outcomes Obtained in Patients Undergoing Intrauterine Insemination with Donor Sperm Previously Vitrified - Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: intrauterine insemination
sperm cryopreservation
sperm vitrification
Lead sponsor: Clínica EUGIN
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ART couples where the female partner is under 35 years old who are undergoing their first attempt of intrauterine artificial insemination with donor semen

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 weeks after procedure
Secondary outcomes:
measure: Percentage of sperm progressive motility
timeFrame: Day of procedure
measure: Total number of sperm with progressive motility
timeFrame: Day of procedure
measure: Biochemical pregnancy rate
timeFrame: 14 days after procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinica EUGIN
Study officials:
affiliation: Clinica EUGIN, Barcelona (Spain)
name: Marc Torra-Massana, PhD
role: PRINCIPAL_INVESTIGATOR
References: