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Protein S Activity in Women With Unexplained Infertility

Protein S Activity in Women With Unexplained Infertility

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03670758
Enrollment
60
Registered
2018-09-14
Start date
2018-09-05
Completion date
2018-09-05
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained Female Infertility

Brief summary

This study will add: Finding out an association between Protein S activity and unexplained female infertility. Aim: Study hypothesis: In women with unexplained infertility protein S activity may be low. Study question: In women with unexplained infertility does protein S activity low?. This study aims to assess the activity of protein S activity in women with unexplained infertility. Objectives: The main objective of this study is: To determine the prevalence of Protein S activity with unexplained female infertility and to compare its prevalence in fertile women among women attending outpatient clinics at Ain Shams University Maternity Hospital.

Detailed description

1. Type of Study: Case Control Study. 2. Study Setting: Ain Shams University Maternity Hospital: outpatient Infertility clinic and outpatient gynecology clinic. 3. Study Population: The study will include women with unexplained infertility (Group 1; cases) and fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions nor history of secondary infertility (Group 2; control). Group 1: Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic. Group 2; another 30 fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions; will recruited from outpatient gynecology clinic as control. According to inclusion and exclusion criteria listed below. Inclusion criteria: 1. Age: 18 - 35 years old. 2. Normal husband's semen analysis, (WHO criteria): 1. Count ≥ 15 million/ml. 2. Motility: ≥ 40% 3. Morphology: ≥ 4% normal morphology. 3. Documented ovulation. 4. Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin. 5. Patent Fallopian tubes. 6. Normal uterine cavity. Exclusion criteria: 1. Patients aged less than 18 years or more than 35 years old. 2. Secondary infertility 3. Presence of male factor infertility 4. Anovulatory cycles. 5. Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded. 6. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction) 7. Patients with recurrent abortion.

Interventions

DIAGNOSTIC_TESTProtein S activity

Intravenous blood sample

Sponsors

Ain Shams Maternity Hospital
CollaboratorOTHER
Esraa Gamal Ahmed
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age: 18 - 35 years old. 2. Normal husband's semen analysis, (WHO criteria): 1. Count ≥ 15 million/ml. 2. Motility: ≥ 40% 3. Morphology: ≥ 4% normal morphology. 3. Documented ovulation. 4. Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin. 5. Patent Fallopian tubes. 6. Normal uterine cavity. \-

Exclusion criteria

1. Patients aged less than 18 years or more than 35 years old. 2. Secondary infertility 3. Presence of male factor infertility 4. Anovulatory cycles. 5. Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded. 6. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction) 7. Patients with recurrent abortion. -

Design outcomes

Primary

MeasureTime frameDescription
Protein S activitysix monthsvenous blood sample

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026