Serum Amyloid A in Women With Unexplained Infertility

Infertility Clinical Trial

Official title:

Serum Amyloid A Level in Women With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918200
• Other study ID #: SAAI
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: March 10, 2019

Study information

• Verified date: April 2019
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 10, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Serum amyloid A level
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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between SAA level between cases and control.		1 day (once)
Secondary	Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).		1 day (once)