Clinical trial NCT06684951: Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility
Keywords: Implantation
Infertility
Human Chorionic Gonadotropin
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The patient\&#39;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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Primary outcomes:
measure: 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
timeFrame: 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
measure: Ultrasound Parameter (RI,PI)
timeFrame: Within 10 minutes after ova pickup, ten minute before embryo transfer using ultrasound device
measure: Systole Flow/ Diastole Flow
timeFrame: within ten minute post ova pickup and ten minute prior to embryo transfer which is done within 3-5 days post ova pickup
Secondary outcomes:
measure: Intra Cytoplasmic Sperm Injection Outcome
timeFrame: 14 days after embryo transfer beta-hCG titer performed to asses pregnancy
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: High Institute for Infertility Diagnosis and Assisted Reproductive Technology
Study officials:
affiliation: High Institute for Infertility Diagnosis and Reproductive Technique
name: Manal T Al-Obaidi, phD.
role: STUDY_DIRECTOR
References: