Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

Phase 4

Completed

• Conditions: Female Infertility
• Interventions: Drug: hCG

• Registration Number: NCT06684951
• Lead Sponsor: Omayma Ismail Khalaf

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.

Study Timeline

• Study Start: 2022-10-23
• Primary Completion: 2024-01-23
• Study Completion: 2024-04-30
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-11-10
• Study First Posted: 2024-11-12
• Results First Submitted: 2024-11-25
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Results First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

4. The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	hCG	Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
Group B	hCG	Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup

Primary Outcome Measures

Name	Time	Method
Serum Level of TNF-alfa,IL-10, TNF/IL-10 Ratio and Resistence Index, Pulsatile Index and Systole/Diastole Ratio 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, doppler ultrasound performed within ten minute post pickup, At day of embryo transfer about 3-5 days post ova pickup blood sample taken and ultrasound exam performed within ten minute before 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 befor embryo transfer) to asses both marker, ultrasound performed twice for each patients at same days (ova pickup day (within ten minute post pickup) and embryo transfer day (ten minute before embryo transfer) to asses subendometrial blood flow parameter like resistence index, pulsatile index and systole /diastole ratio
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

High Institute for Infertility Diagnosis and Assisted Reproductive Technology; 🇮🇶 Baghdad, Iraq