Serum Amyloid A in Women With Unexplained Infertility

Sponsor

Ain Shams Maternity Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03918200

Collaborator

(none)

Enrollment

Location

5.3

Actual Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Serum amyloid A level

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Serum Amyloid A Level in Women With Unexplained Infertility

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Mar 10, 2019

Actual Study Completion Date :

Mar 10, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Difference between SAA level between cases and control. [1 day (once)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospital	Cairo		Egypt

Sponsors and Collaborators

Ain Shams Maternity Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zeinab Saad Abd El Wahab, Doctor, Ain Shams Maternity Hospital

ClinicalTrials.gov Identifier:

NCT03918200

Other Study ID Numbers:

SAAI

First Posted:

Apr 17, 2019

Last Update Posted:

Apr 17, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Apr 17, 2019