Infertile PatientsPhase 2NCT06937645
the Effect of Hyaluronic Acid Intrauterine Wash on Endometrial Receptivity and Pregnancy Outcome
A Phase 2 study testing Hyaluronic Acid (HA) and platlet rich plasma (PRP) in people with Infertile Patients, run by Al-Nahrain University at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertile Patients
- What is being tested?
- Hyaluronic Acid (HA) and platlet rich plasma (PRP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2023to 1 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
high institute for infertility diagnosis and ARTS
AL-Kadimya, Baghdad Governorate
Lubna Amer Al anbari, Ph.D., 00964 7729420158, dr.lubna@st.nahrainuniv.edu.iq
About this study
Official title: 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
- Conditions
- Infertile Patients
- Being tested
- Hyaluronic Acid (HA), platlet rich plasma (PRP)
- Keywords
- hyaluronic acid, intrauterine wash, endometrial receptivity, pregnancy outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks from the day of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Sep 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Nahrain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ghada bassim raaf, Al-Nahrain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937645
- Sponsor's protocol ID
- 0701-PF-2023G12
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Hyaluronic Acid Platelets Rich Plasma on the Endometrial Receptivity and Intracytoplasmic Sperms Injection Outcome
- ClinicalTrials.gov ID
- NCT06937645
- Acronym / sponsor ID
- 0701-PF-2023G12
- Conditions
- Infertile Patients
- Keywords
- hyaluronic acid, intrauterine wash, endometrial receptivity, pregnancy outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the uterine cavity washed with hyaluronic acid preparation on the day of ooc | Experimental | Drug: Hyaluronic Acid (HA)40 infertile patients had their uterine cavity with hyaluronic acid preparation on the day of oocytes retrieval in ICSI |
| 40 infertile females had their uterine cavity washed with PRP preparation | Experimental | Drug: platlet rich plasma (PRP)40 infertile females had their uterine cavity washed with PRP preparation on the day of oocytes retrieval in ICSI |
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid (HA)hyaluronic acid PRP preparation used to wash the endometrium on the day of oocytes retrieval | Drug | the uterine cavity washed with hyaluronic acid preparation on the day of ooc |
| platlet rich plasma (PRP)PRP preparation used to wash the uterine cavity on the day of oocytes retrieval | Drug | 40 infertile females had their uterine cavity washed with PRP preparation |
Primary outcome
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.
1 secondary outcome
measuring serum level of beta human chorionic gonadotropin
Time frame: 2 weeks from the day of oocyte retrieval
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyaluronic Acid (HA) and platlet rich plasma (PRP) in people with Infertile Patients, run by Al-Nahrain University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ghada bassim raaf, Ph.D. (+9647714728261, ghadaalanssari@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.