anti_endometrial Antibodies in Endometriosis

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: Anti-endometrial Antibodies
• Intervention / Treatment: Diagnostic test: serum anti-endometrial antibodies

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

Study Locations

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

Participation Criteria

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

How is the study designed?

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	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	find correlation between serum anti-endometrial antibodies and egg quality retrieved	baseline

Collaborators and Investigators

• 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

General Publications

• Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
• Hummelshoj L, Prentice A, Groothuis P. Update on endometriosis. Womens Health (Lond). 2006 Jan;2(1):53-6. doi: 10.2217/17455057.2.1.53. No abstract available.
• Geva E, Amit A, Lerner-Geva L, Lessing JB. Autoimmunity and reproduction. Fertil Steril. 1997 Apr;67(4):599-611. doi: 10.1016/s0015-0282(97)81351-9.
• Choudhury SR, Knapp LA. Human reproductive failure I: immunological factors. Hum Reprod Update. 2001 Mar-Apr;7(2):113-34. doi: 10.1093/humupd/7.2.113.
• Palacio JR, Iborra A, Ulcova-Gallova Z, Badia R, Martinez P. The presence of antibodies to oxidative modified proteins in serum from polycystic ovary syndrome patients. Clin Exp Immunol. 2006 May;144(2):217-22. doi: 10.1111/j.1365-2249.2006.03061.x.

Helpful Links

• Related Info

Study record dates

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: Endometriosis; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• 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