InfertilityNCT03918200
Serum Amyloid A in Women With Unexplained Infertility
An observational study of Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Serum amyloid A level
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 10 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Infertile women attending Ain Shams University infertility outpatient clinic seeking fertility and fulfilling the criteria.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Sarcoidosis
- Diabetes Mellitus
- Using hormonal contraception (for control group)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Amyloid A Level 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.
- Conditions
- Infertility
- Being tested
- Serum amyloid A level
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum amyloid A levelOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study | Women with unexplained infertility Receives: 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. Receives: Other: Serum amyloid A level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between SAA level between cases and control.
Measured: 1 day (once)
Secondary outcomes (1)
Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).
Measured: 1 day (once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Oct 2018
- Primary completion10 Mar 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Saad Abd El Wahab, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918200
- Sponsor's protocol ID
- SAAI
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Amyloid A Level in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03918200
- Acronym / sponsor ID
- SAAI
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Other: Serum amyloid A levelWomen with unexplained infertility |
| Control | – | Other: Serum amyloid A levelFertile women who had normal physical and pelvic examination, regular menstrual cycles, don't use hormonal contraceptive, had one child at least. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Infertile women attending Ain Shams University infertility outpatient clinic seeking fertility and fulfilling the criteria.
Key inclusion criteria (8 listed)
- 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):
Key exclusion criteria (9 listed)
- Age above 40
- Smoking females
- Obesity (BMI>30)
- Women with any systemic or medical diseases leads to elevation of SAA as:
- Using hormonal contraception (for control group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum amyloid A levelFor 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 | Other | Control, Study |
Primary outcome
Difference between SAA level between cases and control.
Time frame: 1 day (once)
1 secondary outcome
Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).
Time frame: 1 day (once)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between SAA level between cases and control. (time frame: 1 day (once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.