NCT06243913

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

January 25, 2024

Last Update Submit

December 16, 2024

Conditions

Infertility

Keywords

intrauterine inseminationsperm cryopreservationsperm vitrification

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Fetal heartbeat observed in the 7th week of gestation.

    7 weeks after procedure

Secondary Outcomes (3)

  • Percentage of sperm progressive motility

    Day of procedure

  • Total number of sperm with progressive motility

    Day of procedure

  • Biochemical pregnancy rate

    14 days after procedure

Study Arms (1)

Intervention arm

Use of vitrified donor semen for Intrauterine Artificial Insemination

Procedure: IUI with vitrified sperm from donor:

Interventions

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.

Intervention arm

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Patients undergoing Artificial Insemination with sperm from donor.
  • Female partner's age \< 35 years
  • First IUI attempt
  • Caucasian phenotype

You may not qualify if:

  • Any adverse medical condition that may significantly affect reproductive outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica EUGIN

Barcelona, Barcelona, 08006, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Marc Torra-Massana, PhD

    Clinica EUGIN, Barcelona (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 6, 2024

Study Start

December 20, 2022

Primary Completion

December 13, 2024

Study Completion

December 13, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)