Serum Amyloid A in Women With Unexplained Infertility
Serum Amyloid A Level in Women With Unexplained Infertility
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedApril 17, 2019
April 1, 2019
5 months
April 15, 2019
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Difference between SAA level between cases and control.
1 day (once)
Secondary Outcomes (1)
Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).
1 day (once)
Study Arms (2)
Study
Women with unexplained infertility
Control
Fertile women who had normal physical and pelvic examination, regular menstrual cycles, don't use hormonal contraceptive, had one child at least.
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
Eligibility Criteria
Infertile women attending Ain Shams University infertility outpatient clinic seeking fertility and fulfilling the criteria.
You may qualify if:
- women with unexplained infertility (unprotected, regular intercourse for at least 2 years).
- Nulligravida ,Regular mensturation.
- Age less than 40 years .
- Normal parameters (in the study group):
- hormonal profile (day 2 FSH,LH), midluteal phase progesterone, Prolactin, TSH
- transvaginal ultrasound
- hysterosalpingography
- detailed semen analysis
You may not qualify if:
- Age above 40
- Smoking females
- Obesity (BMI\>30)
- Women with any systemic or medical diseases leads to elevation of SAA as:
- Systemic lupus erythematosis
- Rheumatoid arthritis
- Sarcoidosis
- Diabetes Mellitus
- Using hormonal contraception (for control group)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Hospital
Cairo, Egypt
Biospecimen
serum sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 17, 2019
Study Start
October 1, 2018
Primary Completion
March 10, 2019
Study Completion
March 10, 2019
Last Updated
April 17, 2019
Record last verified: 2019-04