Anti-endometrial AntibodiesNCT05851352
anti_endometrial Antibodies in Endometriosis
An observational study of Anti-endometrial Antibodies, run by South Valley University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Anti-endometrial Antibodies
- What is being tested?
- serum anti-endometrial antibodies
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- Women only
- Child, Adult
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.
Who may be able to join
- 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): ≤ 30.
- 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.
Who cannot join
- 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,
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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:
- Detailed history and clinical examination.
- Ovarian reserve testing (serum AMH , basal serum FSH and basal AFC by US)
- Uterine cavity examination ( by trasvaginal 3-dimentional ultrasound or office hysteroscopy)
- routine investigations (Complete blood count, blood grouping , liver function tests , kidney function tests , prothrombin time , prothrombin concentration , serum bloog sugar)
- 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:
- 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
- Conditions
- Anti-endometrial Antibodies
- Being tested
- serum anti-endometrial antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum anti-endometrial antibodiesDiagnostic test
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Dec 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anti-endometrial AntibodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Zain Al_a'bdeen, South Valley University
- Investigators
- Abdelrahman A Elsayed, professor, Study chair, South Valley Universitymostafa M Khodry, lecturer, Study chair, South Valley UniversityRadwa M Fahmy, lecturer, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851352
- Sponsor's protocol ID
- anti_endometrial antibodies
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PubMed 15541453Hummelshoj 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 19803926Geva 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 9093180Choudhury 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 11284658Palacio 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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Serum Anti-endometrial Antibodies in Implantation Rate for Patient With Endometriosis Undergoing Intracytoplasmic Sperm Injection Cycles
- ClinicalTrials.gov ID
- NCT05851352
- Acronym / sponsor ID
- anti_endometrial antibodies
- Conditions
- Anti-endometrial Antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Detailed history and clinical examination.
- Ovarian reserve testing (serum AMH , basal serum FSH and basal AFC by US)
- Uterine cavity examination ( by trasvaginal 3-dimentional ultrasound or office hysteroscopy)
- routine investigations (Complete blood count, blood grouping , liver function tests , kidney function tests , prothrombin time , prothrombin concentration , serum bloog sugar)
- 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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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): ≤ 30.
- primary or secondary infirtility. 5 duration of infertility less than 10 years
Key exclusion criteria (3 listed)
- 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,
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 .This assay employs the qualitative enzyme immunoassay technique | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
serum antiendometrial antibodies in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles and egg quality retrieved
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 15541453Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
- Background: PubMed 19803926Hummelshoj 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.
- Background: PubMed 9093180Geva 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.
- Background: PubMed 11284658Choudhury 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.
- Background: PubMed 16634794Palacio 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-endometrial Antibodies, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum antiendometrial antibodies and implantation rate in patient with endometriosis who undergoing intracytoplasmic sperm injection cycles (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851352, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.