Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

Study the Effects of Intrauterine Flushing With Low Dose Human Chorionic Gonadotropin on Ultrasound Parameter and Immunological Marker of Endometrial Receptivity of Infertile Female Undergoing ICSI Cycle

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.

Study Overview

• Status: Completed
• Conditions: Female Infertility
• Intervention / Treatment: Drug: hCG

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • High Institute for Infertility Diagnosis and Assisted Reproductive Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup	Drug: hCG; observe hCG effect on endometrial receptivity
Active Comparator: Group B; Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup	Drug: hCG; observe hCG effect on endometrial receptivity
No Intervention: group C; patient not receive any treatement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Omayma Ismail Khalaf
• Investigators: Study Director: Manal T Al-Obaidi, phD., High Institute for Infertility Diagnosis and Reproductive Technique

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2022
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Infertility; Implantation; Human Chorionic Gonadotropin
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 0701-PF-2022O10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes