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

April 18, 2025 updated by: ghada bassim raaf, Al-Nahrain University

the Effect of Hyaluronic Acid Platelets Rich Plasma on the Endometrial Receptivity and Intracytoplasmic Sperms Injection 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
    • Baghdad
      • AL-Kadimya, Baghdad, Iraq
        • Recruiting
        • high institute for infertility diagnosis and ARTS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the uterine cavity washed with hyaluronic acid preparation on the day of ooc
40 infertile patients had their uterine cavity with hyaluronic acid preparation on the day of oocytes retrieval in ICSI
Drug: Hyaluronic Acid (HA)
hyaluronic acid PRP preparation used to wash the endometrium on the day of oocytes retrieval
Experimental: 40 infertile females had their uterine cavity washed with PRP preparation
40 infertile females had their uterine cavity washed with PRP preparation on the day of oocytes retrieval in ICSI
Drug: platlet rich plasma (PRP)
PRP preparation used to wash the uterine cavity on the day of oocytes retrieval
No Intervention: 40 infertile females with no intervention for their uterus
40 infertile females with no intervention for their uterus on the day of oocytes retrieval in ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks from the day of oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Nahrain University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0701-PF-2023G12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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