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

NCT06937645 | Recruiting Phase 2 DMC

• 1 other identifier: 0701-PF-2023G12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Infertile Patients

Keywords

hyaluronic acid; intrauterine wash; endometrial receptivity; pregnancy outcome

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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

  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 Outcomes (1)

• measuring serum level of beta human chorionic gonadotropin

  2 weeks from the day of oocyte retrieval

Study Arms (3)

the uterine cavity washed with hyaluronic acid preparation on the day of ooc

EXPERIMENTAL

40 infertile patients had their uterine cavity with hyaluronic acid preparation on the day of oocytes retrieval in ICSI

Drug: Hyaluronic Acid (HA)

40 infertile females had their uterine cavity washed with PRP preparation

EXPERIMENTAL

40 infertile females had their uterine cavity washed with PRP preparation on the day of oocytes retrieval in ICSI

Drug: platlet rich plasma (PRP)

40 infertile females with no intervention for their uterus

NO INTERVENTION

40 infertile females with no intervention for their uterus on the day of oocytes retrieval in ICSI

Interventions

Hyaluronic Acid (HA) DRUG

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

the uterine cavity washed with hyaluronic acid preparation on the day of ooc

platlet rich plasma (PRP) DRUG

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

40 infertile females had their uterine cavity washed with PRP preparation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

high institute for infertility diagnosis and ARTS

AL-Kadimya, Baghdad Governorate, Iraq

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

ghada bassim raaf, Ph.D.

CONTACT

+9647714728261; ghadaalanssari@yahoo.co.uk

lubna alanbari, Ph.D.

CONTACT

07729420158; dr.lubna@st.nahrainuniv.edu.iq

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 22, 2025
• Study Start: September 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)