Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Brief Title:
Sperm Motility and IUI Live Birth Rate
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
Official Title:
Intrauterine Insemination Outcomes Based on WHO 2021 Manual Assessment of Total Rapidly Progressing Motile Sperm Count
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUI
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 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
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
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 75 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 Pearsons chi-square or Fishers exact test
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 75 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 Pearsons chi-square or Fishers exact test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None