Sperm Motility and IUI Live Birth Rate

Infertility Clinical Trial

— IUI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117995
• Other study ID #: 02/23/DD-BVMD
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2023
• Source: M? Ð?c Hospital
• Contact: Tuong M Ho
• Phone: +84 02873085885
• Email: tuong.hm[@]myduchospital.vn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 536
• Est. completion date: December 30, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
M? Ð?c Hospital	M? Ð?c Phú Nhu?n Hospital, Phuong Chi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total motile sperm count after sperm preparation	Total motile sperm count after sperm preparation, measured by million sperm	At 5 minutes after sperm preparation for IUI
Secondary	Biochemical pregnancy rate	Biochemical pregnancy defined as a serum beta-hCG level greater than 25 mIU/ml at day 14 after insemination	At 14 days after insemination
Secondary	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	At 7 weeks of gestation
Secondary	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.	Before 22 weeks of gestational age
Secondary	Multiple pregnancy rate	Multiple pregnancy defined as two or more gestational sacs or two or more positive heart beats by transvaginal sonography	At 7 weeks of gestation
Secondary	Preterm delivery rate	Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation	At birth
Secondary	Gestational age at delivery	Gestational age at delivery.	At birth
Secondary	Birth weigh	Weight of newborn	At birth
Secondary	Stillbirth rate	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
Secondary	Congenital abnormalities rate	Any congenital abnormalities detected in the newborn	At birth

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