Sperm Motility and IUI Live Birth Rate

NCT06117995 | Unknown

• 1 other identifier: 02/23/DD-BVMD
• Study Type: observational
• Target: 536
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective cohort study aims to establish a cut-off threshold for pre-washed total rapidly motile sperm count (TRMSC) based on WHO 2021 criteria to predict the live birth rate following intrauterine insemination (IUI). The study seeks to answer two key questions:

1. 1.Is there a correlation between TRMSC, as per the WHO 2021 criteria, and the live birth rate after IUI?
2. 2.What is the appropriate cut-off threshold of TRMSC to predict a positive live birth outcome after IUI? Couples undergoing ovulation induction and IUI for indicated reasons will participate in the study. On the day of insemination, the pre-washed semen from the husband will be assessed according to the WHO 2021 criteria. The outcomes of the IUI procedure will be documented.

Conditions

Infertility

Keywords

sperm motility; rapid progressive motile sperm; WHO 2021; intrauterine insemination; live birth rate

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 24 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. In the analysis for the primary endpoint, twin delivery will be considered.

  At 24 weeks of gestation

Secondary Outcomes (10)

• Total motile sperm count after sperm preparation

  At 5 minutes after sperm preparation for IUI

• Biochemical pregnancy rate

  At 14 days after insemination

• Clinical pregnancy rate

  At 7 weeks of gestation

• Miscarriage rate

  Before 22 weeks of gestational age

• Multiple pregnancy rate

  At 7 weeks of gestation

Study Arms (1)

Infertile couples have indication of IUI

Infertile couples have an indication of IUI

Other: Assessment the pre-washed sperm motility before IUI

Interventions

Assessment the pre-washed sperm motility before IUI OTHER

The pre-washed sperm motility will be assessed by using WHO 2021 guidelines, stratified into four groups.

Infertile couples have indication of IUI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Live babies born in couples undergo intrauterine insemination

You may qualify if:

• Patient undergoing IUI
• Undergone \<4 previous IUI cycles
• Total progressive motility sperm count before sperm preparation: \> 5million
• Agree to participate in the study

You may not qualify if:

• Using frozen semen

Sponsors & Collaborators

• Mỹ Đức Hospital: lead
• Mỹ Đức Phú Nhuận Hospital: collaborator
• Phương Chi Hospital: collaborator

Related Links

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MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tuong M Ho

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuong M Ho

CONTACT

+84 02873085885; tuong.hm@myduchospital.vn

Tuyen D Duong

CONTACT

+84979369699; tuyen.dnd@myduchospital.vn

Study Design

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

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 30, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share