Serum Amyloid A 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams University Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Serum amyloid A level

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

Primary outcomes

Difference between SAA level between cases and control.

Time frame: 1 day (once)

Secondary outcomes

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

Time frame: 1 day (once)

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Serum Amyloid A Level in Women With Unexplained Infertility

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Apr 17, 2019
Registry last updated: Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed