Infertile Patients
Conditions
Keywords
hyaluronic acid, intrauterine wash, endometrial receptivity, pregnancy outcome
Brief summary
Hyaluronic acid intrauterine wash is done for infertile females undergoing intracytoplasmic sperm injection on the day of oocyte retrieval. endometrial receptivity parameters, including the subendometrial vasculature indices were measured before and after the intervention for purpose of studying the effect of hyaluronic acid on improvement of the endometrial receptivity and subsequently the pregnancy outcome
Interventions
DRUGHyaluronic Acid (HA)
hyaluronic acid PRP preparation used to wash the endometrium on the day of oocytes retrieval
PRP preparation used to wash the uterine cavity on the day of oocytes retrieval
Sponsors
Al-Nahrain University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Infertile females aged 18-40 years. * Infertile females scheduled for GnRH antagonist protocol of fresh ICSI cycle. * Females use dual stimulation (GnRH agonist plus Ovetrelle) for ovulation triggering.
Exclusion criteria
* Infertile females diagnosed as a poor responder. * Infertile females diagnosed with uterine pathology. * Infertile females who are scheduled for a frozen ICSI cycle. * Infertile females diagnosed with endocrine diseases like thyroid disease, diabetes mellitus, and hyperprolactinemia. * Infertile females diagnosed with thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measuring the value of resistance index (RI) of the sub-endometrial blood vessels | for each participant twice measure will be done for (RI). The first measure will be performed on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval. | We will measure the value of the resistance index (RI) using the transvaginal ultrasound Doppler study. For each patient, RI will be measured twice: the first measure will be done before the intervention on the day of oocyte retrieval, and the second measure will be performed after the intervention on the day of embryo transfer. we will calculate RI according to the following equation Resistance index (RI)= \[Peak Systolic Velocity (PSV) cm/sec - End Diastolic Velocity (EDV) cm/sec \] / Peak Systolic Velocity (PSV) cm/sec Then a statistical comparison will be made to evaluate the difference between the two readings to study the effect of the intervention on the measured parameter for each group. |
| measuring the value of sub- endometrial vessels pulsatile index (PI) | for each participant twice measure will be done for PI. The first measure is on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval. | We will measure the value of the pulsatile index (PI) using the transvaginal ultrasound Doppler study. PI will be measured twice for each patient: once before the oocyte retrieval intervention and once after the embryo transfer intervention. then PI will be calculated according to the following equation Pulsatility Index (PI) = \[Peak Systolic Velocity (PSV) cm/sec - end Diastolic Velocity (EDV) cm/sec \] / Mean Velocity (MV) cm/sec Then a statistical comparison will be made to evaluate the difference between the two readings to study the effect of the intervention on the measured parameter for each group. |
| measuring the value of peak systolic to end diastolic ratio (S/D) of the sub-endometrial blood vessels | for each participant twice measure will be done for S/D. The first measure is on the day of oocyte retrieval and the second measure on the day of embryo transfer which is done 3-5 days after oocyte retrieval. | We will measure the value of the peak systolic to end diastolic ratio (S/D) using the transvaginal ultrasound Doppler study. For each patient, S/D will be measured twice: the first measure will be done before the intervention on the day of oocyte retrieval, and the second measure will be performed after the intervention on the day of embryo transfer. S/D will be calculated according to the following equation S/D= Peak Systolic Velocity (PSV) cm/sec /End Diastolic Velocity (ED) cm/sec Then a statistical comparison will be made to evaluate the difference between the two readings to study the effect of the intervention on the measured parameter for each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| measuring serum level of beta human chorionic gonadotropin | 2 weeks from the day of oocyte retrieval | We will assess the effect of hyaluronic acid intrauterine wash on improving the pregnancy outcome in infertile patients undergoing intracytoplasmic sperm injection (ICSI). Two weeks after the day of oocyte retrieval, we will measure the serum level of beta human chorionic gonadotropin (B HCG) in mIU/mL to test for successful pregnancy. The pregnancy rates will be compared between the study groups using statistical analysis to see how effective hyaluronic acid intrauterine wash is on pregnancy outcomes compared to the PRP and control groups. |
Countries
Iraq
Contacts
Primary Contactghada bassim raaf, Ph.D.
Backup Contactlubna alanbari, Ph.D.
Outcome results
None listed