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Effects of Intrauterine Flushing With Human Chorionic Gonadotropin on ICSI Outcome

O

Omayma Ismail Khalaf

Status and phase

Completed
Phase 4

Conditions

Female Infertility

Treatments

Drug: hCG

Study type

Interventional

Funder types

Other

Identifiers

NCT06684951
0701-PF-2022O10

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

  1. Instances of congenital abnormalities in the reproductive system are being examined.

  2. 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.

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Group A
Active Comparator group
Description:
Intrauterine infusion of 700IU of human chorionic gonadotropin once immediately after ova pickup
Treatment:
Drug: hCG
Group B
Active Comparator group
Description:
Intrauterine infusion of 500IU of human chorionic gonadotropin once immediately after ova pickup
Treatment:
Drug: hCG
group C
No Intervention group
Description:
patient not receive any treatement

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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