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Clinical Trials/NCT05851352
NCT05851352Active, not recruitingNot Applicable

Predictive Value of Serum Anti-endometrial Antibodies in Implantation Rate for Patient With Endometriosis Undergoing Intracytoplasmic Sperm Injection Cycles

South Valley University1 site in 1 country30 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Locations
1
Primary Endpoint
serum antiendometrial antibodies and implantation rate in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles

Study Overview

Brief Summary

The aims of this study is to asses the predictive value of serum anti_endometrial antibodies in prediction of implantation rate in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles.

Detailed Description

prospective cohort study of infertile patients ( with endometriosis & adenomyosis) who will undergo ICSI cycles at the assisted reproduction units,Obstetrics and Gynacology departments , South Valley University and Cairo University.

Initial evaluation: this will include:

  1. Detailed history and clinical examination.
  2. Ovarian reserve testing (serum AMH , basal serum FSH and basal AFC by US)
  3. Uterine cavity examination ( by trasvaginal 3-dimentional ultrasound or office hysteroscopy)
  4. routine investigations (Complete blood count, blood grouping , liver function tests , kidney function tests , prothrombin time , prothrombin concentration , serum bloog sugar)
  5. Evaluation of male factor (husbnad semen analysis)
  • Eligible women will undergo :

  • Transvaginal ultrasound for evaluation of endometriosis ( shape , size , unilateral or bilateral , unilocular or bilocular )

  • Perform laparscopy for confirmation of endometriosis using revised ASM classification for endometriosis

  • Measurement of serum anti_endometrial antibodies :

  • Take blood samples from patients to measure anti-endometrial antibody concentrations in the serum of women with endometriosis using human Endometrium Antibody, EMAb ELISA Kit .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to 35 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients will be enrolled in this study if they fulfill the following criteria:
  • infertile patients (with endometriosis & adenomyosis ) who will undergo ICSI cycles
  • Age: 18-35 years.
  • Body mass index (BMI): ≤
  • primary or secondary infirtility. 5 duration of infertility less than 10 years
  • results of semen examination of patients' husbands will be within the World Health Organization (WHO) reference range.

Exclusion Criteria

  • Patients will not be eligible for this study if:
  • gynecological problem e.g. uterine polyp, hydrosalpinx will be excluded
  • Male factor: Abnormal sperm morphology;(globozoospermia and pin- point sperm) will be excluded 3 . congenital structural abnormalities of the reproductive tract, pelvic tuberculosis, ovarian tumour, hyperprolactinaemia, adrenal disease, thyroid disease or other endocrine disease,

Outcomes

Primary Outcomes

serum antiendometrial antibodies and implantation rate in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles

Time Frame: baseline

assess the predictive value of serum antiendometrial antibodies in prediction of implantation rate in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles

Secondary Outcomes

  • serum antiendometrial antibodies in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles and egg quality retrieved(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Zain Al_a'bdeen

doctor

South Valley University

Study Sites (1)

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