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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup |
|
| Group B | Active Comparator | Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup |
|
| group C | No Intervention | patient not receive any treatement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hCG | Drug | observe hCG effect on endometrial receptivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, | 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 | 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 | 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 | within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup |
| Measure | Description | Time Frame |
|---|---|---|
| Intra Cytoplasmic Sperm Injection Outcome | Number of patients who get pregnant after ICSI in each study group | 14 days after embryo transfer beta-hCG titer performed to asses pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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.
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intertile female age (18-40), no history of endocrinological disease
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| Name | Affiliation | Role |
|---|---|---|
| Manal T Al-Obaidi, phD. | High Institute for Infertility Diagnosis and Reproductive Technique | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Institute for Infertility Diagnosis and Assisted Reproductive Technology | Baghdad | Iraq |
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Participants were recruited based on patients whom attended the out patient clinic of the High Institute for Infertility Diagnosis and Assisted reproductive technique/ Al Nahrain university, between October 2022 and January 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity |
| FG001 | Group B | Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity |
| FG002 | Group C | patient not receive any treatement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity |
| BG001 | Group B | Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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, | Posted | Mean | Standard Deviation | pg/ml | 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 |
|
1 year
information about adverse event effect performed using questionnaire, regular laboratory testing and the intervention is by using intrauterine infusion of low dose of drug which nearly carry no risk to the patients
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity and biochemical marker including TNF-alfa and IL-10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Omaima Ismail Khalaf | AlNahrain university | 9647831475217 | khokh7871@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2024 | Oct 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2024 | Oct 19, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2024 | Oct 25, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| BG002 | Group C | patient not receive any treatement |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | all participants were infertile female attended out patient clinic for high institute for infertility diagnosis and assisted repr0ductive technique | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | aii patients enrolled in the study collected from high institute for infertility diagnosis and assisted reproductive technique / Al Nahrain university | Count of Participants | Participants |
|
| Body mass index (BMI) Kg/m^2 | Count of Participants | Participants |
|
| Type of infertility (primary/secondary) | Count of Participants | Participants |
|
| Cause of infertility | Count of Participants | Participants |
|
| Duration of infertility | Count of Participants | Participants |
|
| OG001 | Group B | Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity |
| OG002 | Group C | patient not receive any treatement |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | index | Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device |
|
|
|
| Primary | Systole Flow/ Diastole Flow | ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio | Posted | Mean | Standard Deviation | ratio | within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | ratio | within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup |
|
|
|
| Secondary | Intra Cytoplasmic Sperm Injection Outcome | Number of patients who get pregnant after ICSI in each study group | Posted | Count of Participants | Participants | 14 days after embryo transfer beta-hCG titer performed to asses pregnancy |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Group B | Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup hCG: observe hCG effect on endometrial receptivity | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Group C | patient not receive any treatement | 0 | 30 | 0 | 30 | 0 | 30 |
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| D000091662 | Genital Diseases |
| 25-34 |
|
| ≥ 35 |
|
| over weight |
|
| obese |
|
| secondary |
|
| female factor |
|
| Combined |
|
| Unexplained |
|
| 5 - 9 years |
|
| ≥ 10 years |
|
|
| Pulsatile index day of pickup |
|
| Pulsatile index day of transfer |
|
|
|