Serum Amyloid A in Women With Unexplained Infertility

Completed

• Conditions: Infertility
• Interventions: Other: Serum amyloid A level

• Registration Number: NCT03918200
• Lead Sponsor: Ain Shams Maternity Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-03-10
• Study Completion: 2019-03-10
• Status Verified: 2019-04
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-16
• Study First Posted: 2019-04-17
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study	Serum amyloid A level	Women with unexplained infertility
Control	Serum amyloid A level	Fertile women who had normal physical and pelvic examination, regular menstrual cycles, don't use hormonal contraceptive, had one child at least.

Primary Outcome Measures

Name	Time	Method
Difference between SAA level between cases and control.	1 day (once)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt