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

NCT ID: NCT06243913

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-20

Study Completion Date

2024-12-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility

Keywords

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intrauterine insemination sperm cryopreservation sperm vitrification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention arm

Use of vitrified donor semen for Intrauterine Artificial Insemination

IUI with vitrified sperm from donor:

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clínica EUGIN

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Torra-Massana, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica EUGIN, Barcelona (Spain)

Locations

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Clinica EUGIN

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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BIOKIBANK

Identifier Type: -

Identifier Source: org_study_id