Infertility, Female
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Ain Shams Maternity Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. regular cycles. 2. normal thyroid function, prolactin and androgen levels. 3. normal semen analysis of the partner. 4. normal hysterosalpingography. 5. normal transvaginal ultrasound examination.
Exclusion criteria
1. possible uterine malformations or pathologies. 2. presence of infections, including hepatitis, human immunodeficiency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma. 3. presence of anti-sperm antibodies in serum. 4. Male factor infertility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Helicobacter Pylori IgG Assay in Serum | 24 hours | calculation of quantitative Helicobacter pylori IgG assay in serum |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unexplained Infertility Patients 44 patients diagnosed to have unexplained infertility | 44 |
| Fertile Women 44 fertile women | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Fertile Women | Total | Unexplained Infertility Patients |
|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 4.9 | 28.06 years STANDARD_DEVIATION 5.12 | 28.3 years STANDARD_DEVIATION 5.4 |
| parity nullipara | 0 participants | 41 participants | 41 participants |
| parity para 1 | 13 participants | 15 participants | 2 participants |
| parity para 2 | 20 participants | 21 participants | 1 participants |
| parity para 3 | 10 participants | 10 participants | 0 participants |
| parity para 4 | 1 participants | 1 participants | 0 participants |
| serum estradiole level | 34.52 picogram per millilitre STANDARD_DEVIATION 12.41 | 41.04 picogram per millilitre STANDARD_DEVIATION 14.02 | 47.56 picogram per millilitre STANDARD_DEVIATION 16.55 |
| serum FSH level | 4.21 international unit per litre STANDARD_DEVIATION 1.85 | 5.53 international unit per litre STANDARD_DEVIATION 3.12 | 6.85 international unit per litre STANDARD_DEVIATION 2.17 |
| serum LH level | 4.41 international unit per litre STANDARD_DEVIATION 3.21 | 4.92 international unit per litre STANDARD_DEVIATION 2.11 | 5.43 international unit per litre STANDARD_DEVIATION 2.69 |
| serum progesterone level | 15.01 nanogram per millilitre STANDARD_DEVIATION 5.21 | 14.55 nanogram per millilitre STANDARD_DEVIATION 5.52 | 14.09 nanogram per millilitre STANDARD_DEVIATION 4.91 |
| serum prolactin level | 9.21 nanogram per millilitre STANDARD_DEVIATION 4.91 | 8.72 nanogram per millilitre STANDARD_DEVIATION 3.45 | 8.23 nanogram per millilitre STANDARD_DEVIATION 3.39 |
| Sex: Female, Male Female | 44 Participants | 88 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| type of infertility no infertility | 44 participants | 44 participants | 0 participants |
| type of infertility primary infertility | 0 participants | 41 participants | 41 participants |
| type of infertility secondary infertility | 0 participants | 3 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Quantitative Helicobacter Pylori IgG Assay in Serum
calculation of quantitative Helicobacter pylori IgG assay in serum
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unexplained Infertility Patients | Quantitative Helicobacter Pylori IgG Assay in Serum | 70 arbitrary unit per millilitre |
| Fertile Women | Quantitative Helicobacter Pylori IgG Assay in Serum | 70 arbitrary unit per millilitre |
p-value: <0.001Wilcoxon (Mann-Whitney)