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Serum Amyloid A in Women With Unexplained Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03918200
Recruitment Status : Completed
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zeinab Saad Abd El Wahab, Ain Shams Maternity Hospital

Study Description
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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
Infertility Other: Serum amyloid A level

Study Design
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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 : October 1, 2018
Actual Primary Completion Date : March 10, 2019
Actual Study Completion Date : March 10, 2019

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Difference between SAA level between cases and control. [ Time Frame: 1 day (once) ]

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

Biospecimen Retention:   Samples Without DNA
serum sample

Eligibility Criteria
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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infertile women attending Ain Shams University infertility outpatient clinic seeking fertility and fulfilling the criteria.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918200


Locations
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Egypt
Ain Shams University Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital
More Information
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Responsible Party: Zeinab Saad Abd El Wahab, Doctor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03918200    
Other Study ID Numbers: SAAI
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility