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CompletedNCT03918200Updated Apr 17, 2019

Serum Amyloid A in Women With Unexplained Infertility

An observational study in Infertility, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged Up to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Ain Shams Maternity Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
Up to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 90 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 40 Years
Sexes eligible
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.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Study

    Women with unexplained infertility

    Other: Serum amyloid A 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

Interventions

  • OtherSerum 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

06

What researchers measure

Primary outcomes

  1. Difference between SAA level between cases and control.

    Time frame: 1 day (once)

Secondary outcomes

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

    Time frame: 1 day (once)

07

Study locations

1 site
  • Ain Shams University Hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03918200
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Zeinab Saad Abd El Wahab (Doctor, Ain Shams Maternity Hospital) — Principal investigator
First posted
Apr 17, 2019
Start date
Oct 1, 2018
Primary completion
Mar 10, 2019
Completion
Mar 10, 2019
Last update
Apr 17, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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