Female InfertilityPhase 4NCT06684951
Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome
A Phase 4 study testing hCG in people with Female Infertility, run by Omayma Ismail Khalaf at 1 site in Iraq.
Trial summary
a number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 23 Oct 2022to 30 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient\'s consent to participate in the research study is crucial for data collection and analysis.
- Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process.
- The age range of the female participants varied from 18 to 40 years.
- Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined.
- Male-related factors contributing to infertility were also taken into consideration.
- The procedure involved the transfer of grade one embryos during a fresh cycle.
Who cannot join
- Endometrioses, whether clinically suspected or discovered during laparoscopy, are of interest.
- 2. Instances of congenital abnormalities in the reproductive system are being examined.
- 3. Individuals above the age of forty are under consideration. 4. Individuals who do not possess G1 embryos are also included. 5. Patients with chronic systemic conditions (such as diabetes, hematologic disorders, hypertension, autoimmune disorders of the connective tissue, asthma, thyroid disorders) are a part of the study.
- 6. The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.
- -
Trial locations and contacts
1 site in 1 country.
Iraq1 site
High Institute for Infertility Diagnosis and Assisted Reproductive Technology
Baghdad
About this study
Official title: Study the Effects of Intrauterine Flushing With Low Dose Human Chorionic Gonadotropin on Ultrasound Parameter and Immunological Marker of Endometrial Receptivity of Infertile Female Undergoing ICSI Cycle
a number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter.
Read the detailed description
Ninety infertile women included. Written informed consent was obtained before being included in the study. Three groups of patients according to type of intervention. Assessment of plasma hormone level was done for all. The quantification of serum TNF and IL-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (ELISA) methodology at a privately-owned laboratory.
- Conditions
- Female Infertility
- Being tested
- hCG
- Keywords
- Implantation, Infertility, Human Chorionic Gonadotropin
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCGDrug
observe hCG effect on endometrial receptivity
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup Receives: Drug: hCG |
| Group B | Active comparator | Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup Receives: Drug: hCG |
| group C | No intervention | patient not receive any treatement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer
All participants in the study had a blood sample taken on the day of ovum retrieval (within 10 minute after ova pickup) for the purpose of measuring the level of interleukin-10 and TNF-alfa in the blood, and a second sample was taken on the day of embryo transfer (ten minute before embryo transfer) to asses both marker,
Measured: at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent
Ultrasound Parameter (RI,PI)
assessment of sub-endometrial blood flow indicis immediately within 10 minute post ova pickup and second exam within ten minute before embryo transfer day which is within 3-5 days of ova pickup there are no maximum or minimum value for the parameter to be measured and lower value is better these measure was performed by using ultrasound device
Measured: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device
Systole Flow/ Diastole Flow
ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio
Measured: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
TNF-alfa/IL-10 Ratio
ratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer
Measured: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
Secondary outcomes (1)
Intra Cytoplasmic Sperm Injection Outcome
Number of patients who get pregnant after ICSI in each study group
Measured: 14 days after embryo transfer beta-hCG titer performed to asses pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start23 Oct 2022
- Primary completion23 Jan 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omayma Ismail Khalaf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omayma Ismail Khalaf, Al-Nahrain University
- Investigators
- Manal T Al-Obaidi, phD., Study director, High Institute for Infertility Diagnosis and Reproductive Technique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684951
- Sponsor's protocol ID
- 0701-PF-2022O10
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2024
- Last updated
- 19 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effects of Intrauterine Flushing With Low Dose Human Chorionic Gonadotropin on Ultrasound Parameter and Immunological Marker of Endometrial Receptivity of Infertile Female Undergoing ICSI Cycle
- ClinicalTrials.gov ID
- NCT06684951
- Acronym / sponsor ID
- 0701-PF-2022O10
- Conditions
- Female Infertility
- Keywords
- Implantation, Infertility, Human Chorionic Gonadotropin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Omayma Ismail KhalafUniversity, hospital or other
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
a number of infertile women who were prepared for ICSI and immediately post ova pick up intrauterine flushing with human chorionic gonadotropin was done to study the effect of this drug on ICSI outcome and ultrasound parameter.
Detailed description
Ninety infertile women included. Written informed consent was obtained before being included in the study. Three groups of patients according to type of intervention. Assessment of plasma hormone level was done for all. The quantification of serum TNF and IL-10 levels was conducted through the application of the enzyme-linked immunosorbent assay (ELISA) methodology at a privately-owned laboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: hCGIntrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup |
| Group B | Active comparator | Drug: hCGIntrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup |
| group C | No intervention | –patient not receive any treatement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient\'s consent to participate in the research study is crucial for data collection and analysis.
- Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process.
- The age range of the female participants varied from 18 to 40 years.
- Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined.
- Male-related factors contributing to infertility were also taken into consideration.
Key exclusion criteria (5 listed)
- Endometrioses, whether clinically suspected or discovered during laparoscopy, are of interest.
- 2. Instances of congenital abnormalities in the reproductive system are being examined.
- 3. Individuals above the age of forty are under consideration. 4. Individuals who do not possess G1 embryos are also included. 5. Patients with chronic systemic conditions (such as diabetes, hematologic disorders, hypertension, autoimmune disorders of the connective tissue, asthma, thyroid disorders) are a part of the study.
- 6. The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.
- -
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 |
|---|---|---|
| hCGobserve hCG effect on endometrial receptivity | Drug | Group A, Group B |
Primary outcome
Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer
Time frame: at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent
All participants in the study had a blood sample taken on the day of ovum retrieval (within 10 minute after ova pickup) for the purpose of measuring the level of interleukin-10 and TNF-alfa in the blood, and a second sample was taken on the day of embryo transfer (ten minute before embryo transfer) to asses both marker,
Ultrasound Parameter (RI,PI)
Time frame: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device
assessment of sub-endometrial blood flow indicis immediately within 10 minute post ova pickup and second exam within ten minute before embryo transfer day which is within 3-5 days of ova pickup there are no maximum or minimum value for the parameter to be measured and lower value is better these measure was performed by using ultrasound device
Systole Flow/ Diastole Flow
Time frame: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio
TNF-alfa/IL-10 Ratio
Time frame: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
ratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer
1 secondary outcome
Intra Cytoplasmic Sperm Injection Outcome
Time frame: 14 days after embryo transfer beta-hCG titer performed to asses pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Manal T Al-Obaidi, phD. study director
High Institute for Infertility Diagnosis and Reproductive Technique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hCG in people with Female Infertility, run by Omayma Ismail Khalaf 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 6 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: finished, as of the sponsor's last update on 19 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Level of TNF-alfa,IL-10, for All Participants in Three Study Group at Day of Ova Pickup Compared to That at Day of Embryo Transfer (time frame: at day of ova pickup a blood sample aspirated, and on day of embryo transfer about 3-5 days post ova pickup blood sample taken within ten minute before embryo transfer to asses serum level of TNF-alfa and IL-10 for all participent). The study lists 4 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 19 Sep 2025.