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Serum Amyloid A in Women With Unexplained Infertility

Serum Amyloid A Level in Women With Unexplained Infertility

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03918200
Enrollment
90
Registered
2019-04-17
Start date
2018-10-01
Completion date
2019-03-10
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

High follicular fluid amyloid A level is associated with reduced pregnancy rate. The aim of this study was to find an association between serum level of amyloid A and unexplained infertility.

Interventions

For determination of SAA level, a 5-ml sample of venous blood will be taken from each participant under aseptic conditions, and centrifuged at 2500 g for 15 minutes at 4°C c. separated into serum aliquots,and stored frozen at -80°C until analysis of SAA ,which will be done by a double-antibody sandwich Enzyme Linked Immunosorbent Assay (ELISA) kits supplied by cusabio,USA according to manufacturers instruction .Each sample was tested in duplicate and the average will be taken. A cut off level of 30 mg/L SAA level will be chosen to reflect a real increase in its level

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. women with unexplained infertility (unprotected, regular intercourse for at least 2 years). 2. Nulligravida ,Regular mensturation. 3. Age less than 40 years . 4. Normal parameters (in the study group): * hormonal profile (day 2 FSH,LH), midluteal phase progesterone, Prolactin, TSH * transvaginal ultrasound * hysterosalpingography * detailed semen analysis

Exclusion criteria

1. Age above 40 2. Smoking females 3. Obesity (BMI\>30) 4. Women with any systemic or medical diseases leads to elevation of SAA as: 1. Systemic lupus erythematosis 2. Rheumatoid arthritis 3. Sarcoidosis 4. Diabetes Mellitus 5. Using hormonal contraception (for control group)

Design outcomes

Primary

MeasureTime frame
Difference between SAA level between cases and control.1 day (once)

Secondary

MeasureTime frame
Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).1 day (once)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026