Trial Outcomes & Findings for Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility (NCT NCT02684604)

NCT ID: NCT02684604

Last Updated: 2016-05-16

Results Overview

calculation of quantitative Helicobacter pylori IgG assay in serum

• Recruitment status: COMPLETED
• Target enrollment: 88 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2016-05-16

Participant Flow

Participant milestones

Measure	Unexplained Infertility Patients 44 patients diagnosed to have unexplained infertility	Fertile Women 44 fertile women
Overall Study STARTED	44	44
Overall Study COMPLETED	44	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility

Baseline characteristics by cohort

Measure	Unexplained Infertility Patients n=44 Participants 44 patients diagnosed to have unexplained infertility	Fertile Women n=44 Participants 44 fertile women	Total n=88 Participants Total of all reporting groups
Age, Continuous	28.3 years STANDARD_DEVIATION 5.4 • n=93 Participants	27.8 years STANDARD_DEVIATION 4.9 • n=4 Participants	28.06 years STANDARD_DEVIATION 5.12 • n=27 Participants
Sex: Female, Male Female	44 Participants n=93 Participants	44 Participants n=4 Participants	88 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
parity nullipara	41 participants n=93 Participants	0 participants n=4 Participants	41 participants n=27 Participants
parity para 1	2 participants n=93 Participants	13 participants n=4 Participants	15 participants n=27 Participants
parity para 2	1 participants n=93 Participants	20 participants n=4 Participants	21 participants n=27 Participants
parity para 3	0 participants n=93 Participants	10 participants n=4 Participants	10 participants n=27 Participants
parity para 4	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
type of infertility no infertility	0 participants n=93 Participants	44 participants n=4 Participants	44 participants n=27 Participants
type of infertility primary infertility	41 participants n=93 Participants	0 participants n=4 Participants	41 participants n=27 Participants
type of infertility secondary infertility	3 participants n=93 Participants	0 participants n=4 Participants	3 participants n=27 Participants
serum FSH level	6.85 international unit per litre STANDARD_DEVIATION 2.17 • n=93 Participants	4.21 international unit per litre STANDARD_DEVIATION 1.85 • n=4 Participants	5.53 international unit per litre STANDARD_DEVIATION 3.12 • n=27 Participants
serum LH level	5.43 international unit per litre STANDARD_DEVIATION 2.69 • n=93 Participants	4.41 international unit per litre STANDARD_DEVIATION 3.21 • n=4 Participants	4.92 international unit per litre STANDARD_DEVIATION 2.11 • n=27 Participants
serum prolactin level	8.23 nanogram per millilitre STANDARD_DEVIATION 3.39 • n=93 Participants	9.21 nanogram per millilitre STANDARD_DEVIATION 4.91 • n=4 Participants	8.72 nanogram per millilitre STANDARD_DEVIATION 3.45 • n=27 Participants
serum estradiole level	47.56 picogram per millilitre STANDARD_DEVIATION 16.55 • n=93 Participants	34.52 picogram per millilitre STANDARD_DEVIATION 12.41 • n=4 Participants	41.04 picogram per millilitre STANDARD_DEVIATION 14.02 • n=27 Participants
serum progesterone level	14.09 nanogram per millilitre STANDARD_DEVIATION 4.91 • n=93 Participants	15.01 nanogram per millilitre STANDARD_DEVIATION 5.21 • n=4 Participants	14.55 nanogram per millilitre STANDARD_DEVIATION 5.52 • n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

calculation of quantitative Helicobacter pylori IgG assay in serum

Outcome measures

Measure	Unexplained Infertility Patients n=44 Participants 44 patients diagnosed to have unexplained infertility	Fertile Women n=44 Participants 44 fertile women
Quantitative Helicobacter Pylori IgG Assay in Serum	70 arbitrary unit per millilitre Interval 7.5 to 70.0	70 arbitrary unit per millilitre Interval 70.0 to 70.0

Adverse Events

Unexplained Infertility Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fertile Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

amr ahmed mahmoud riad

Ain Shams Maternity hospital

Phone: 01005347179

Email: amr.riad@med.asu.edu.eg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place