Serum Amyloid A in Women With Unexplained Infertility

NCT ID: NCT03918200

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-03-10

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.

Conditions

Infertility

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Study

Women with unexplained infertility

Serum amyloid A level

Intervention Type: OTHER

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.

Serum amyloid A level

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zeinab Saad Abd El Wahab

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SAAI

Identifier Type: -

Identifier Source: org_study_id