Infertility, FemaleNCT02684604
Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility
An observational study of Infertility, Female, run by Ain Shams Maternity Hospital.
Trial summary
Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: female healthy participants who attend the outpatient clinic
Who may be able to join
- regular cycles.
- normal thyroid function, prolactin and androgen levels.
- normal semen analysis of the partner.
- normal hysterosalpingography.
- normal transvaginal ultrasound examination.
Who cannot join
- possible uterine malformations or pathologies.
- presence of infections, including hepatitis, human immunodeficiency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.
- presence of anti-sperm antibodies in serum.
- Male factor infertility.
About this study
Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.
Read the detailed description
Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.
Following admission, all patients underwent complete clinical examination and detailed medical history was obtained.
A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).
- Conditions
- Infertility, Female
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| unexplained infertility patients | 44 patients diagnosed to have unexplained infertility | |
| Fertile women | 44 fertile women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Helicobacter Pylori IgG Assay in Serum
calculation of quantitative Helicobacter pylori IgG assay in serum
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infertility, FemaleStudies 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
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684604
- Sponsor's protocol ID
- unexplained infertility
- Status last verified
- Apr 2016
- First submitted
- 8 Feb 2016
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT02684604
- Acronym / sponsor ID
- unexplained infertility
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 4 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.
Detailed description
Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.
Following admission, all patients underwent complete clinical examination and detailed medical history was obtained.
A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unexplained infertility patients | – | –44 patients diagnosed to have unexplained infertility |
| Fertile women | – | –44 fertile women |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- female healthy participants who attend the outpatient clinic
Key inclusion criteria (5 listed)
- regular cycles.
- normal thyroid function, prolactin and androgen levels.
- normal semen analysis of the partner.
- normal hysterosalpingography.
- normal transvaginal ultrasound examination.
Key exclusion criteria (4 listed)
- possible uterine malformations or pathologies.
- presence of infections, including hepatitis, human immunodeficiency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.
- presence of anti-sperm antibodies in serum.
- Male factor infertility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative Helicobacter Pylori IgG Assay in Serum
Time frame: 24 hours
calculation of quantitative Helicobacter pylori IgG assay in serum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ain Shams Maternity Hospital.
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 5 inclusion and 4 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quantitative Helicobacter Pylori IgG Assay in Serum (time frame: 24 hours). 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 16 May 2016.