Trial Outcomes & Findings for Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome (NCT NCT06684951)
NCT ID: NCT06684951
Last Updated: 2025-09-19
Results Overview
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,
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
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
Results posted on
2025-09-19
Participant Flow
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.
Participant milestones
| Measure |
Group A
Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group B
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
patient not receive any treatement
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=30 Participants
Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group B
n=30 Participants
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
n=30 Participants
patient not receive any treatement
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
age of participants (years) · Age < 25
|
5 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
13 Participants
n=90 Participants
|
|
Age, Customized
age of participants (years) · 25-34
|
17 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
18 Participants
n=30 Participants
|
56 Participants
n=90 Participants
|
|
Age, Customized
age of participants (years) · ≥ 35
|
8 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
21 Participants
n=90 Participants
|
|
Sex/Gender, Customized
female participant
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Iraq
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
|
Body mass index (BMI) Kg/m^2
Normal BMI
|
4 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
18 Participants
n=90 Participants
|
|
Body mass index (BMI) Kg/m^2
over weight
|
20 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
18 Participants
n=30 Participants
|
51 Participants
n=90 Participants
|
|
Body mass index (BMI) Kg/m^2
obese
|
6 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
21 Participants
n=90 Participants
|
|
Type of infertility (primary/secondary)
primary
|
26 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
28 Participants
n=30 Participants
|
77 Participants
n=90 Participants
|
|
Type of infertility (primary/secondary)
secondary
|
4 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
13 Participants
n=90 Participants
|
|
Cause of infertility
male factor
|
22 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
64 Participants
n=90 Participants
|
|
Cause of infertility
female factor
|
1 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
11 Participants
n=90 Participants
|
|
Cause of infertility
Combined
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=90 Participants
|
|
Cause of infertility
Unexplained
|
5 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=90 Participants
|
|
Duration of infertility
< 5 years
|
8 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
26 Participants
n=90 Participants
|
|
Duration of infertility
5 - 9 years
|
9 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
33 Participants
n=90 Participants
|
|
Duration of infertility
≥ 10 years
|
13 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
31 Participants
n=90 Participants
|
PRIMARY outcome
Timeframe: 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 participentAll 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,
Outcome measures
| Measure |
Group A
n=30 Participants
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
|
Group B
n=30 Participants
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
n=30 Participants
patient not receive any treatement
|
|---|---|---|---|
|
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
|
41.59 pg/ml
Standard Deviation 8.4
|
40.94 pg/ml
Standard Deviation 14.4
|
|
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
|
38.06 pg/ml
Standard Deviation 10.6
|
42.3 pg/ml
Standard Deviation 18.7
|
|
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
|
27.08 pg/ml
Standard Deviation 4.9
|
25.57 pg/ml
Standard Deviation 8.3
|
|
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
|
23.4 pg/ml
Standard Deviation 5.6
|
25.51 pg/ml
Standard Deviation 12.8
|
PRIMARY outcome
Timeframe: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound deviceassessment 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
Outcome measures
| Measure |
Group A
n=30 Participants
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
|
Group B
n=30 Participants
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
n=30 Participants
patient not receive any treatement
|
|---|---|---|---|
|
Ultrasound Parameter (RI,PI)
Resistance index day of pickup
|
0.49 index
Standard Deviation 0.06
|
0.51 index
Standard Deviation 0.08
|
0.5 index
Standard Deviation 0.05
|
|
Ultrasound Parameter (RI,PI)
Resistance index day of transfer
|
0.42 index
Standard Deviation 0.07
|
0.48 index
Standard Deviation 0.1
|
0.5 index
Standard Deviation 0.07
|
|
Ultrasound Parameter (RI,PI)
Pulsatile index day of pickup
|
0.8 index
Standard Deviation 0.14
|
0.85 index
Standard Deviation 0.22
|
0.79 index
Standard Deviation 0.16
|
|
Ultrasound Parameter (RI,PI)
Pulsatile index day of transfer
|
0.64 index
Standard Deviation 0.21
|
0.82 index
Standard Deviation 0.25
|
0.78 index
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickupultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio
Outcome measures
| Measure |
Group A
n=30 Participants
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
|
Group B
n=30 Participants
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
n=30 Participants
patient not receive any treatement
|
|---|---|---|---|
|
Systole Flow/ Diastole Flow
systole/ diastole ratio day of pickup
|
2.05 ratio
Standard Deviation 0.3
|
2.3 ratio
Standard Deviation 0.5
|
2.01 ratio
Standard Deviation 0.3
|
|
Systole Flow/ Diastole Flow
systole/diastole ratio day of transfer
|
1.87 ratio
Standard Deviation 0.3
|
2.21 ratio
Standard Deviation 0.8
|
1.92 ratio
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickupratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer
Outcome measures
| Measure |
Group A
n=30 Participants
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
|
Group B
n=30 Participants
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
n=30 Participants
patient not receive any treatement
|
|---|---|---|---|
|
TNF-alfa/IL-10 Ratio
TNF/IL-10 ratio at day of ova pickup
|
1.89 ratio
Standard Deviation 0.46
|
1.56 ratio
Standard Deviation 0.33
|
1.71 ratio
Standard Deviation 0.47
|
|
TNF-alfa/IL-10 Ratio
TNF/IL-10 ratio at day of embryo transfer
|
1.38 ratio
Standard Deviation 0.32
|
1.66 ratio
Standard Deviation 0.38
|
1.86 ratio
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 14 days after embryo transfer beta-hCG titer performed to asses pregnancyNumber of patients who get pregnant after ICSI in each study group
Outcome measures
| Measure |
Group A
n=30 Participants
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
|
Group B
n=30 Participants
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
hCG: observe hCG effect on endometrial receptivity
|
Group C
n=30 Participants
patient not receive any treatement
|
|---|---|---|---|
|
Intra Cytoplasmic Sperm Injection Outcome
non-pregnant women
|
14 Participants
|
18 Participants
|
22 Participants
|
|
Intra Cytoplasmic Sperm Injection Outcome
pregnant women
|
16 Participants
|
12 Participants
|
8 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place