Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

NCT06684951 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 0701-PF-2022O10
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Keywords

Implantation; Infertility; Human Chorionic Gonadotropin

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (1)

• Intra Cytoplasmic Sperm Injection Outcome

  14 days after embryo transfer beta-hCG titer performed to asses pregnancy

Study Arms (3)

Group A

ACTIVE COMPARATOR

Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup

Drug: hCG

Group B

ACTIVE COMPARATOR

Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup

Drug: hCG

group C

NO INTERVENTION

patient not receive any treatement

Interventions

hCG DRUG

observe hCG effect on endometrial receptivity

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: intertile female age (18-40), no history of endocrinological disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omayma Ismail Khalaf: lead

Study Sites (1)

High Institute for Infertility Diagnosis and Assisted Reproductive Technology

Baghdad, Iraq

Location

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Omaima Ismail Khalaf
• Organization: AlNahrain university

khokh7871@gmail.com

9647831475217

Study Officials

• Manal T Al-Obaidi, phD.

  High Institute for Infertility Diagnosis and Reproductive Technique

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: November 12, 2024
• Study Start: October 23, 2022
• Primary Completion: January 23, 2024
• Study Completion: April 30, 2024
• Last Updated: September 19, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)