Sperm Motility and IUI Live Birth Rate (IUI)

November 3, 2023 updated by: Mỹ Đức Hospital

Intrauterine Insemination Outcomes Based on WHO 2021 Manual Assessment of Total Rapidly Progressing Motile Sperm Count

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. Is there a correlation between TRMSC, as per the WHO 2021 criteria, and the live birth rate after IUI?
  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients will be enrolled in the study on the day of intrauterine insemination (IUI). Both spouses will receive detailed information about the study and provide informed consent. Sperm motility will be evaluated according to the WHO 2021 guidelines before filtration and washing.

Ovarian stimulation will be conducted using human menopausal gonadotropins (hMG) with regular ultrasound monitoring of follicular development. Once the lead follicle reaches a size of 18mm, ovulation will be induced using hCG. If six or more follicles reach a size of 14mm, the patient will be advised to cancel the cycle or consider in-vitro fertilization (IVF). IUI will be performed 36-38 hours after hCG injection.

For patients who prefer non-injection-based ovarian stimulation, an oral agent using letrozole will be offered. Letrozole with a dosage of 5 to 7.5 mg will be administered orally from days 2-5 of the menstrual cycle, and ovarian follicle development will be assessed through ultrasound on day 10.

Sperm samples will be collected through masturbation at the hospital after a period of 2-5 days of ejaculation abstinence. Motility analysis will be performed based on the WHO 2021 guidelines, which classify sperm as rapid progressive (A), slow progressive (B), non-progressive (C), or immotile (D), using the formula: percentage of rapid progressive sperm x density x volume. Semen parameters, including volume, density, and normal morphology ratio, will also be evaluated according to the WHO 2021 guidelines.

The collected sample will undergo processing using the density gradient method, following the WHO 2021 guidelines. The processed semen will be used for IUI, and its concentration and motility will be examined.

During the insemination procedure, a Gynétic soft catheter will be used. After the procedure, the patient will rest for 15 - 20 minutes, followed by luteal-phase support using vaginal micronized progesterone for 14 days. The presence of hCG in the blood will be tested after 14 days to determine a biochemical pregnancy. Confirmation of clinical pregnancy will be based on ultrasound observation of a gestational sac at 7 weeks of gestational age. Prenatal care until delivery will be provided either at specified hospitals or through regular contact.

During delivery, data on labour, delivery, and any complications experienced by the participant or newborn will be collected. Participants who cannot attend prenatal care at the designated hospitals will be contacted regularly for data collection. Descriptive analysis will be used to describe the background characteristics of the study population, presenting continuous variables as means and standard deviations (SD) and comparing them using appropriate statistical tests. Categorical variables will be presented as percentages and compared using relevant statistical tests such as Pearson's chi-square or Fisher's exact test.

Study Type

Observational

Enrollment (Estimated)

536

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Live babies born in couples undergo intrauterine insemination

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Using frozen semen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infertile couples have indication of IUI
Infertile couples have an indication of IUI
Other: Assessment the pre-washed sperm motility before IUI
The pre-washed sperm motility will be assessed by using WHO 2021 guidelines, stratified into four groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: At 24 weeks of gestation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total motile sperm count after sperm preparation
Time Frame: At 5 minutes after sperm preparation for IUI
Total motile sperm count after sperm preparation, measured by million sperm
At 5 minutes after sperm preparation for IUI
Multiple pregnancy rate
Time Frame: At 7 weeks of gestation
Multiple pregnancy defined as two or more gestational sacs or two or more positive heart beats by transvaginal sonography
At 7 weeks of gestation
Miscarriage rate
Time Frame: Before 22 weeks of gestational age
Miscarriage defined as spontaneous loss of a clinical pregnancy before week 22 of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus.
Before 22 weeks of gestational age
Gestational age at delivery
Time Frame: At birth
Gestational age at delivery.
At birth
Congenital abnormalities rate
Time Frame: At birth
Any congenital abnormalities detected in the newborn
At birth
Biochemical pregnancy rate
Time Frame: At 14 days after insemination
Biochemical pregnancy defined as a serum beta-hCG level greater than 25 mIU/ml at day 14 after insemination
At 14 days after insemination
Clinical pregnancy rate
Time Frame: At 7 weeks of gestation
Clinical pregnancy defined as the presence of at least one gestational sac on ultrasound at week 7 of gestation with the detection of heart beat activity, after insemination
At 7 weeks of gestation
Preterm delivery rate
Time Frame: At birth
Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation
At birth
Birth weigh
Time Frame: At birth
Weight of newborn
At birth
Stillbirth rate
Time Frame: After 28 completed weeks of gestational age
Stillbirth defined as the death of a fetus prior to the complete expulsion or extraction from its mother
After 28 completed weeks of gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mỹ Đức Hospital

Collaborators

Mỹ Đức Phú Nhuận Hospital
Phương Chi Hospital

Investigators

  • Principal Investigator: Tuong M Ho, Mỹ Đức Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/23/DD-BVMD

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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