Serum Amyloid A in Women With Unexplained Infertility

Serum Amyloid A Level in Women With Unexplained Infertility

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Serum amyloid A level

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Infertile women attending Ain Shams University infertility outpatient clinic seeking fertility and fulfilling the criteria.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study; Women with unexplained infertility	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
Control; Fertile women who had normal physical and pelvic examination, regular menstrual cycles, don't use hormonal contraceptive, had one child at least.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between SAA level between cases and control.	1 day (once)

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).	1 day (once)

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): March 10, 2019
• Study Completion (ACTUAL): March 10, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: SAAI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No