Sperm Motility and IUI Live Birth Rate

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Other: Assessment the pre-washed sperm motility before IUI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Preterm delivery rate | Preterm delivery is defined as any delivery at <24, <28, <32, <37 completed weeks' gestation | At birth | 
| Gestational age at delivery | Gestational age at delivery. | At birth | 
| Birth weigh | Weight of newborn | At birth | 
| 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 | 
| Congenital abnormalities rate | Any congenital abnormalities detected in the newborn | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sperm motility, rapid progressive motile sperm, WHO 2021, intrauterine insemination, live birth rate