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Completed

NCT Number: NCT06243913

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica EUGIN

Barcelona, 08006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IUI with vitrified sperm from donor:

Procedure

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.

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 7 weeks after procedure

    Fetal heartbeat observed in the 7th week of gestation.

Secondary outcomes

  1. Percentage of sperm progressive motility

    Time frame: Day of procedure

    Percentage of sperm progressive motility (% a+b) after thawing

  2. Total number of sperm with progressive motility

    Time frame: Day of procedure

    Total number of sperm with progressive motility after thawing

  3. Biochemical pregnancy rate

    Time frame: 14 days after procedure

    Positive pregnancy test

Sponsors and collaborators

Lead sponsor

Clínica EUGIN

Other

Registry information

Official study title

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

Acronym: BIOKIBANK

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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