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

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

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: IUI with vitrified sperm from donor:

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08006
    • Clinica EUGIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Intervention arm; Use of vitrified donor semen for Intrauterine Artificial Insemination

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Fetal heartbeat observed in the 7th week of gestation.	7 weeks after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clínica EUGIN
• Investigators: Principal Investigator: Marc Torra-Massana, PhD, Clinica EUGIN, Barcelona (Spain)

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: intrauterine insemination; sperm cryopreservation; sperm vitrification
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: BIOKIBANK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No