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Active, not recruitingNCT05851352Updated May 9, 2023

anti_endometrial Antibodies in Endometriosis

An observational study in Anti-endometrial Antibodies, sponsored by South Valley University. Active, not recruiting at 1 site in Egypt. Open to female participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by South Valley University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2023, 3 years 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
15 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Anti-endometrial Antibodies

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 30 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
Female
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.

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
  1. results of semen examination of patients' husbands will be within the World Health Organization (WHO) reference range.

Exclusion criteria

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,

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testserum 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 .This assay employs the qualitative enzyme immunoassay technique

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

Secondary outcomes

  1. 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

    Time frame: baseline

07

Study locations

1 site
  • Mohammed Zain Al_a'bdeen
    Qena, Maabar +2, Egypt
08

References and documents

Publications

  • Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5. PubMed 15541453 ↗
  • 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. PubMed 19803926 ↗
  • 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. PubMed 9093180 ↗
  • 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. PubMed 11284658 ↗
  • 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. PubMed 16634794 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851352
Lead sponsor
South Valley University
Responsible party
Mohammed Zain Al_a'bdeen (doctor, South Valley University) — Principal investigator
First posted
May 9, 2023
Start date
Dec 1, 2020
Primary completion
Jun 1, 2023 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
May 9, 2023

Study contacts

Abdelrahman A Elsayed, professor
study chair · South Valley University
mostafa M Khodry, lecturer
study chair · South Valley University
Radwa M Fahmy, lecturer
study chair · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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