Unexplained Female Infertility Clinical Trial
Official title:
Protein S Activity in Women With Unexplained Infertility
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.
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.
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