Protein S Activity in Women With Unexplained Infertility

Study Overview
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Brief Summary
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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
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Type of Study: Case Control Study. Study Setting: Ain Shams University Maternity Hospital: outpatient Infertility clinic and outpatient gynecology clinic. 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: Age: 18 - 35 years old. Normal husband's semen analysis, (WHO criteria): Count ≥ 15 million/ml. Motility: ≥ 40% Morphology: ≥ 4% normal morphology. Documented ovulation. Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin. Patent Fallopian tubes. Normal uterine cavity. Exclusion criteria: Patients aged less than 18 years or more than 35 years old. Secondary infertility Presence of male factor infertility Anovulatory cycles. Tubal block; Tubal disease is an important cause of infertility and should be speciﬁcally excluded. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction) Patients with recurrent abortion.

Official Title
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Protein S Activity in Women With Unexplained Infertility

Conditions
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Unexplained Female Infertility

Intervention / Treatment
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* Diagnostic Test: Protein S activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 - 35 years old. Normal husband's semen analysis, (WHO criteria): Count ≥ 15 million/ml. Motility: ≥ 40% Morphology: ≥ 4% normal morphology. Documented ovulation. Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin. Patent Fallopian tubes. Normal uterine cavity. - Exclusion Criteria: Patients aged less than 18 years or more than 35 years old. Secondary infertility Presence of male factor infertility Anovulatory cycles. Tubal block; Tubal disease is an important cause of infertility and should be speciﬁcally excluded. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction) Patients with recurrent abortion. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic | Diagnostic Test: Protein S activity<br>* Intravenous blood sample<br>|
| Group 2<br>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 | Diagnostic Test: Protein S activity<br>* Intravenous blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein S activity | venous blood sample | six months |