InfertilityIUINCT06117995
Sperm Motility and IUI Live Birth Rate
An observational study of Infertility, run by Mỹ Đức Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility
- What is being tested?
- Assessment the pre-washed sperm motility before IUI
- How many people
- 536 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Live babies born in couples undergo intrauterine insemination
Who may be able to join
- Patient undergoing IUI
- Undergone <4 previous IUI cycles
- Total progressive motility sperm count before sperm preparation: > 5million
- Agree to participate in the study
Who cannot join
- Using frozen semen
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
- Is there a correlation between TRMSC, as per the WHO 2021 criteria, and the live birth rate after IUI?
- 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Assessment the pre-washed sperm motility before IUI
- Keywords
- sperm motility, rapid progressive motile sperm, WHO 2021, intrauterine insemination, live birth rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment the pre-washed sperm motility before IUIOther
The pre-washed sperm motility will be assessed by using WHO 2021 guidelines, stratified into four groups.
| Study group | Role | What they receive |
|---|---|---|
| Infertile couples have indication of IUI | Infertile couples have an indication of IUI Receives: Other: Assessment the pre-washed sperm motility before IUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 weeks of gestation
Secondary outcomes (10)
Total motile sperm count after sperm preparation
Total motile sperm count after sperm preparation, measured by million sperm
Measured: At 5 minutes after sperm preparation for IUI
Biochemical pregnancy rate
Biochemical pregnancy defined as a serum beta-hCG level greater than 25 mIU/ml at day 14 after insemination
Measured: At 14 days after insemination
Clinical pregnancy rate
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
Measured: At 7 weeks of gestation
Miscarriage rate
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.
Measured: Before 22 weeks of gestational age
Multiple pregnancy rate
Multiple pregnancy defined as two or more gestational sacs or two or more positive heart beats by transvaginal sonography
Measured: At 7 weeks of gestation
Preterm delivery rate
Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation
Measured: At birth
Gestational age at delivery
Gestational age at delivery.
Measured: At birth
Birth weigh
Weight of newborn
Measured: At birth
Stillbirth rate
Stillbirth defined as the death of a fetus prior to the complete expulsion or extraction from its mother
Measured: After 28 completed weeks of gestational age
Congenital abnormalities rate
Any congenital abnormalities detected in the newborn
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mỹ Đức Phú Nhuận Hospital, Phương Chi Hospital
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117995
- Sponsor's protocol ID
- 02/23/DD-BVMD
- Acronym
- IUI
- Status last verified
- Mar 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Insemination Outcomes Based on WHO 2021 Manual Assessment of Total Rapidly Progressing Motile Sperm Count
- ClinicalTrials.gov ID
- NCT06117995
- Acronym / sponsor ID
- IUI / 02/23/DD-BVMD
- Conditions
- Infertility
- Keywords
- sperm motility, rapid progressive motile sperm, WHO 2021, intrauterine insemination, live birth rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Collaborators
- Mỹ Đức Phú Nhuận Hospital, Phương Chi Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a correlation between TRMSC, as per the WHO 2021 criteria, and the live birth rate after IUI?
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile couples have indication of IUI | – | Other: Assessment the pre-washed sperm motility before IUIInfertile couples have an indication of IUI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Live babies born in couples undergo intrauterine insemination
Key inclusion criteria (4 listed)
- Patient undergoing IUI
- Undergone <4 previous IUI cycles
- Total progressive motility sperm count before sperm preparation: > 5million
- Agree to participate in the study
Key exclusion criteria (1 listed)
- Using frozen semen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment the pre-washed sperm motility before IUIThe pre-washed sperm motility will be assessed by using WHO 2021 guidelines, stratified into four groups. | Other | Infertile couples have indication of IUI |
Primary outcome
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.
10 secondary outcomes
Total motile sperm count after sperm preparation
Time frame: At 5 minutes after sperm preparation for IUI
Biochemical pregnancy rate
Time frame: At 14 days after insemination
Clinical pregnancy rate
Time frame: At 7 weeks of gestation
Miscarriage rate
Time frame: Before 22 weeks of gestational age
Multiple pregnancy rate
Time frame: At 7 weeks of gestation
Preterm delivery rate
Time frame: At birth
Gestational age at delivery
Time frame: At birth
Birth weigh
Time frame: At birth
Stillbirth rate
Time frame: After 28 completed weeks of gestational age
Congenital abnormalities rate
Time frame: At birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho principal investigator
Mỹ Đức Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Mỹ Đức Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuong M Ho (+84 02873085885 ext. MD, tuong.hm@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: At 24 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.