high institute for infertility diagnosis and ARTS
AL-Kadimya, Baghdad Governorate, Iraq
Location status: Recruiting
Recruiting
NCT Number: NCT06937645
the Effect of Hyaluronic Acid Intrauterine Wash on Endometrial Receptivity and Pregnancy Outcome
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–40 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Hyaluronic Acid (HA)
Drughyaluronic acid PRP preparation used to wash the endometrium on the day of oocytes retrieval
platlet rich plasma (PRP)
DrugPRP preparation used to wash the uterine cavity on the day of oocytes retrieval
Primary outcomes
-
measuring the value of resistance index (RI) of the sub-endometrial blood vessels
Time frame: 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)
Time frame: 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
Time frame: 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 outcomes
-
measuring serum level of beta human chorionic gonadotropin
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
ghada bassim raaf, Ph.D.
CONTACT
lubna alanbari, Ph.D.
CONTACT
Sponsors and collaborators
Lead sponsor
Al-Nahrain University
Other
Registry information
Official study title
the Effect of Hyaluronic Acid Platelets Rich Plasma on the Endometrial Receptivity and Intracytoplasmic Sperms Injection Outcome
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Apr 22, 2025
- Registry last updated
- Apr 22, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.