Protein S Activity in Women With Unexplained Infertility
- Conditions
- Unexplained Female Infertility
- Interventions
- Diagnostic Test: Protein S activity
- Registration Number
- NCT03670758
- Lead Sponsor
- Esraa Gamal Ahmed
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
-
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.
- 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. -
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Protein S activity Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic Group 2 Protein S activity 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
- Primary Outcome Measures
Name Time Method Protein S activity six months venous blood sample
- Secondary Outcome Measures
Name Time Method