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Completed

NCT Number: NCT06684951

Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

High Institute for Infertility Diagnosis and Assisted Reproductive Technology

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient's consent to participate in the research study is crucial for data collection and analysis.
  • Each pair of individuals undergoing IVF/ICSI procedures typically possess grade 1 (G1) embryos during the embryo transfer process.
  • The age range of the female participants varied from 18 to 40 years.
  • Infertility arising from female factors, including issues like blocked fallopian tubes, lack of ovulation, and unexplained fertility challenges, was examined.
  • Male-related factors contributing to infertility were also taken into consideration.
  • 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.

  • Instances of congenital abnormalities in the reproductive system are being examined.
  • 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.
  • The presence of empty follicles is noted in stimulated cycles where no oocytes were obtained during the aspiration procedure.

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Treatment and study plan

HCG

Drug

observe hCG effect on endometrial receptivity

Primary outcomes

  1. 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

    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,

  2. Ultrasound Parameter (RI,PI)

    Time frame: 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

  3. 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

    ultrasound parameter to asses endometrial receptivity by measuring sub-endometrial flow systole / diastole ratio

  4. 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

    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

    Number of patients who get pregnant after ICSI in each study group

Sponsors and collaborators

Lead sponsor

Omayma Ismail Khalaf

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 12, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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