anti_endometrial Antibodies in Endometriosis

May 1, 2023 updated by: Mohammed Zain Al_a'bdeen, South Valley University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 .

Intracytoplasmic sperm injection (ICSI) gonadotrophin stimulation drugs will be used, individualization of stimulation dose and slight modifications will be done according to ovarian response. Proper protocol will be used. Baseline assessment of AFC by transvaginal scans wasill be performed by experienced gynaecologist using a 7.5 MHz vaginal probe 7-MHz (Samsung, Korea). Ovarian response monitoring to stimulation drug, estimation the doses of gonadotrophins required for follicular growing and maturation, assessment the stimulation time in days till time of ovum pick-up, and the number and quality of oocytes obtained will be recorded in and analysed at the end of the study. When 3-4 follicles acquired >18 mm ,triggering of ovulation will be done using human chorionic gonadotrophins 36 hours prior to pick-up of oocytes. after oocyte retrieval ICSI procedure will be done for all cases. embryos will be transferred to each mother on day 3 or day 5 according to embryos quality and remaining of good quality embryos will be frozen for subsequent transfer. Luteal support started in day of ova pick up till date of pregnancy test (14 days post embryos transfer)

Research outcome measures:

a. Primary (main):

  • assess the predictive value of serum antiendometrial antibodies in prediction of implantation rate in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles b. Secondary (subsidiary):
  • to find correlation between serum anti-endometrial antibodies and egg quality retrieved

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Maabar
      • Qena, Maabar, Egypt, +2
        • Mohammed Zain Al_a'bdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

- Patients will be enrolled in this study if they fulfill the following criteria:

  1. infertile patients (with endometriosis & adenomyosis ) who will undergo ICSI cycles
  2. Age: 18-35 years.
  3. Body mass index (BMI): ≤ 30.
  4. primary or secondary infirtility. 5 duration of infertility less than 10 years

6. 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:

1. gynecological problem e.g. uterine polyp, hydrosalpinx will be excluded 2. 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,

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum antiendometrial antibodies in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles and egg quality retrieved
Time Frame: baseline
find correlation between serum anti-endometrial antibodies and egg quality retrieved
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Study Chair: Abdelrahman A Elsayed, professor, South Valley University
  • Study Chair: mostafa M Khodry, lecturer, South Valley University
  • Study Chair: Radwa M Fahmy, lecturer, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 1, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anti_endometrial antibodies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe