Trial · Interventional

CompletedPhase 4Results postedRegistry data

Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

NCTNCT06684951Other id0701-PF-2022O10

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names hCG (human chorionic gonadotropin), does not test it. It appears in the title.

Overview

Status: Completed
Phase: Phase 4
Enrollment: 90 participants (actual)
Sponsor: Omayma Ismail Khalaf · Other
Design: Randomized · Double masking
Countries: 1 country
Iraq
Start: 23 Oct 2022
Primary completion: 23 Jan 2024
Completion: 30 Apr 2024
First posted: 12 Nov 2024
Last update posted: 19 Sept 2025
Conditions: Female Infertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2022202320242025

Ph 4
Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome
NCT06684951
23 Oct 2022 to 30 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

hCGDrug

Arms3

Active comparator
Group A
Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
Active comparator
Group B
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
No intervention
group C
patient not receive any treatement

Primary outcomes4

Outcomes the sponsor listed as 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
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
Registry description
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
Registry description
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
Registry description
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
Registry description
ratio of serum level of TNA-alfa /IL-10 at time of ova pickup and at day of embryo transfer

Secondary outcomes(1)

Intra Cytoplasmic Sperm Injection Outcome
Time frame · 14 days after embryo transfer beta-hCG titer performed to asses pregnancy
Registry description
Number of patients who get pregnant after ICSI in each study group

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

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

Group	Value (pg/ml)	Spread
Group A	43.56	12.6
Group B	41.59	8.4
Group C	40.94	14.4

Primary outcomeMean· Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device

Ultrasound Parameter (RI,PI)

Group	Value (index)	Spread
Group A	0.49	0.06
Group B	0.51	0.08
Group C	0.5	0.05

Primary outcomeMean· within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup

Systole Flow/ Diastole Flow

Group	Value (ratio)	Spread
Group A	2.05	0.3
Group B	2.3	0.5
Group C	2.01	0.3

Primary outcomeMean· 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

Group	Value (ratio)	Spread
Group A	1.89	0.46
Group B	1.56	0.33
Group C	1.71	0.47

Secondary and other outcome results(1)

Secondary outcomeCount of participants· 14 days after embryo transfer beta-hCG titer performed to asses pregnancy

Intra Cytoplasmic Sperm Injection Outcome

Group	Value (Participants)
Group A	16
Group B	12
Group C	8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Group AIntrauterine 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	0 / 30	0 / 30	0 / 30
Group BIntrauterine 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
Group Cpatient not receive any treatement	0 / 30	0 / 30	0 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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. \-

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