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the Effect of Hyaluronic Acid Intrauterine Wash on Endometrial Receptivity and Pregnancy Outcome

ConditionInfertile Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAl-Nahrain University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic Acid (HA)

    Drug

    hyaluronic acid PRP preparation used to wash the endometrium on the day of oocytes retrieval

  • platlet rich plasma (PRP)

    Drug

    PRP preparation used to wash the uterine cavity on the day of oocytes retrieval

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: the uterine cavity washed with hyaluronic acid preparation on the day of oocExperimental treatment 1 intervention
Group B: 40 infertile females had their uterine cavity washed with PRP preparationExperimental treatment 1 intervention
Group C: 40 infertile females with no intervention for their uterusNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

measuring the value of resistance index (RI) of the sub-endometrial blood vessels

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.

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.
2

measuring the value of sub- endometrial vessels pulsatile index (PI)

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.

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.
3

measuring the value of peak systolic to end diastolic ratio (S/D) of the sub-endometrial blood vessels

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.

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.

Secondary outcomes

1

measuring serum level of beta human chorionic gonadotropin

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.

Time frame
2 weeks from the day of oocyte retrieval

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

high institute for infertility diagnosis and ARTSRecruiting AL-Kadimya, Baghdad GovernorateIraqIraq

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Nahrain University

Lead sponsor

Source ClinicalTrials.gov
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