Female Infertility
Conditions
Keywords
Implantation, Infertility, Human Chorionic Gonadotropin
Brief 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.
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.
Interventions
DRUGhCG
observe hCG effect on endometrial receptivity
Sponsors
Omayma Ismail Khalaf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. The patient's consent to participate in the research study is crucial for data collection and analysis. 2. Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process. 3. The age range of the female participants varied from 18 to 40 years. 4. Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined. 5. Male-related factors contributing to infertility were also taken into consideration. 6. The procedure involved the transfer of grade one embryos during a fresh cycle.
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra Cytoplasmic Sperm Injection Outcome | 14 days after embryo transfer beta-hCG titer performed to asses pregnancy | Number of patients who get pregnant after ICSI in each study group |
Countries
Iraq
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group A Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity | 30 |
| Group B Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity | 30 |
| Group C patient not receive any treatement | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | Total | Group A | Group B | Group C |
|---|---|---|---|---|
| Age, Customized age of participants (years) 25-34 | 56 Participants | 17 Participants | 21 Participants | 18 Participants |
| Age, Customized age of participants (years) ≥ 35 | 21 Participants | 8 Participants | 5 Participants | 8 Participants |
| Age, Customized age of participants (years) Age < 25 | 13 Participants | 5 Participants | 4 Participants | 4 Participants |
| Body mass index (BMI) Kg/m^2 Normal BMI | 18 Participants | 4 Participants | 9 Participants | 5 Participants |
| Body mass index (BMI) Kg/m^2 obese | 21 Participants | 6 Participants | 8 Participants | 7 Participants |
| Body mass index (BMI) Kg/m^2 over weight | 51 Participants | 20 Participants | 13 Participants | 18 Participants |
| Cause of infertility Combined | 6 Participants | 2 Participants | 2 Participants | 2 Participants |
| Cause of infertility female factor | 11 Participants | 1 Participants | 4 Participants | 6 Participants |
| Cause of infertility male factor | 64 Participants | 22 Participants | 23 Participants | 19 Participants |
| Cause of infertility Unexplained | 9 Participants | 5 Participants | 1 Participants | 3 Participants |
| Duration of infertility ≥ 10 years | 31 Participants | 13 Participants | 10 Participants | 8 Participants |
| Duration of infertility 5 - 9 years | 33 Participants | 9 Participants | 11 Participants | 13 Participants |
| Duration of infertility < 5 years | 26 Participants | 8 Participants | 9 Participants | 9 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment Iraq | 90 Participants | 30 Participants | 30 Participants | 30 Participants |
| Sex/Gender, Customized female participant | 90 Participants | 30 Participants | 30 Participants | 30 Participants |
| Type of infertility (primary/secondary) primary | 77 Participants | 26 Participants | 23 Participants | 28 Participants |
| Type of infertility (primary/secondary) secondary | 13 Participants | 4 Participants | 7 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
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,
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | 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 | serum level of TNF-alfa at day of ova pickup | 43.56 pg/ml | Standard Deviation 12.6 |
| Group A | 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 | IL-10 day of pickup | 25.26 pg/ml | Standard Deviation 10.9 |
| Group A | 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 | TNF-alfa day of embryo transfer | 30.33 pg/ml | Standard Deviation 5.7 |
| Group A | 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 | IL-10 day of embryo transfer | 25.21 pg/ml | Standard Deviation 14.5 |
| Group B | 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 | IL-10 day of embryo transfer | 23.4 pg/ml | Standard Deviation 5.6 |
| Group B | 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 | IL-10 day of pickup | 27.08 pg/ml | Standard Deviation 4.9 |
| Group B | 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 | serum level of TNF-alfa at day of ova pickup | 41.59 pg/ml | Standard Deviation 8.4 |
| Group B | 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 | TNF-alfa day of embryo transfer | 38.06 pg/ml | Standard Deviation 10.6 |
| Group C | 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 | TNF-alfa day of embryo transfer | 42.3 pg/ml | Standard Deviation 18.7 |
| Group C | 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 | IL-10 day of pickup | 25.57 pg/ml | Standard Deviation 8.3 |
| Group C | 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 | IL-10 day of embryo transfer | 25.51 pg/ml | Standard Deviation 12.8 |
| Group C | 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 | serum level of TNF-alfa at day of ova pickup | 40.94 pg/ml | Standard Deviation 14.4 |
Primary
Systole Flow/ Diastole Flow
ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Systole Flow/ Diastole Flow | systole/ diastole ratio day of pickup | 2.05 ratio | Standard Deviation 0.3 |
| Group A | Systole Flow/ Diastole Flow | systole/diastole ratio day of transfer | 1.87 ratio | Standard Deviation 0.3 |
| Group B | Systole Flow/ Diastole Flow | systole/ diastole ratio day of pickup | 2.3 ratio | Standard Deviation 0.5 |
| Group B | Systole Flow/ Diastole Flow | systole/diastole ratio day of transfer | 2.21 ratio | Standard Deviation 0.8 |
| Group C | Systole Flow/ Diastole Flow | systole/ diastole ratio day of pickup | 2.01 ratio | Standard Deviation 0.3 |
| Group C | Systole Flow/ Diastole Flow | systole/diastole ratio day of transfer | 1.92 ratio | Standard Deviation 0.3 |
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
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | TNF-alfa/IL-10 Ratio | TNF/IL-10 ratio at day of ova pickup | 1.89 ratio | Standard Deviation 0.46 |
| Group A | TNF-alfa/IL-10 Ratio | TNF/IL-10 ratio at day of embryo transfer | 1.38 ratio | Standard Deviation 0.32 |
| Group B | TNF-alfa/IL-10 Ratio | TNF/IL-10 ratio at day of ova pickup | 1.56 ratio | Standard Deviation 0.33 |
| Group B | TNF-alfa/IL-10 Ratio | TNF/IL-10 ratio at day of embryo transfer | 1.66 ratio | Standard Deviation 0.38 |
| Group C | TNF-alfa/IL-10 Ratio | TNF/IL-10 ratio at day of ova pickup | 1.71 ratio | Standard Deviation 0.47 |
| Group C | TNF-alfa/IL-10 Ratio | TNF/IL-10 ratio at day of embryo transfer | 1.86 ratio | Standard Deviation 1.1 |
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
Time frame: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Ultrasound Parameter (RI,PI) | Resistance index day of pickup | 0.49 index | Standard Deviation 0.06 |
| Group A | Ultrasound Parameter (RI,PI) | Pulsatile index day of transfer | 0.64 index | Standard Deviation 0.21 |
| Group A | Ultrasound Parameter (RI,PI) | Resistance index day of transfer | 0.42 index | Standard Deviation 0.07 |
| Group A | Ultrasound Parameter (RI,PI) | Pulsatile index day of pickup | 0.8 index | Standard Deviation 0.14 |
| Group B | Ultrasound Parameter (RI,PI) | Pulsatile index day of pickup | 0.85 index | Standard Deviation 0.22 |
| Group B | Ultrasound Parameter (RI,PI) | Resistance index day of transfer | 0.48 index | Standard Deviation 0.1 |
| Group B | Ultrasound Parameter (RI,PI) | Pulsatile index day of transfer | 0.82 index | Standard Deviation 0.25 |
| Group B | Ultrasound Parameter (RI,PI) | Resistance index day of pickup | 0.51 index | Standard Deviation 0.08 |
| Group C | Ultrasound Parameter (RI,PI) | Pulsatile index day of pickup | 0.79 index | Standard Deviation 0.16 |
| Group C | Ultrasound Parameter (RI,PI) | Resistance index day of transfer | 0.5 index | Standard Deviation 0.07 |
| Group C | Ultrasound Parameter (RI,PI) | Resistance index day of pickup | 0.5 index | Standard Deviation 0.05 |
| Group C | Ultrasound Parameter (RI,PI) | Pulsatile index day of transfer | 0.78 index | Standard Deviation 0.13 |
Secondary
Intra Cytoplasmic Sperm Injection Outcome
Number of patients who get pregnant after ICSI in each study group
Time frame: 14 days after embryo transfer beta-hCG titer performed to asses pregnancy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Intra Cytoplasmic Sperm Injection Outcome | pregnant women | 16 Participants |
| Group A | Intra Cytoplasmic Sperm Injection Outcome | non-pregnant women | 14 Participants |
| Group B | Intra Cytoplasmic Sperm Injection Outcome | pregnant women | 12 Participants |
| Group B | Intra Cytoplasmic Sperm Injection Outcome | non-pregnant women | 18 Participants |
| Group C | Intra Cytoplasmic Sperm Injection Outcome | non-pregnant women | 22 Participants |
| Group C | Intra Cytoplasmic Sperm Injection Outcome | pregnant women | 8 Participants |