Protein S Activity in Women With Unexplained Infertility

Esraa Gamal Ahmed

Status: Unknown

Conditions: Unexplained Female Infertility

Treatments: Diagnostic Test: Protein S activity

Study type: Observational

Funder types: Other

Identifiers

NCT03670758

AinShamsMH EAhmed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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. -

Trial design

60 participants in 2 patient groups

Group 1

Description:

Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic

Treatment:

Diagnostic Test: Protein S activity

Group 2

Description:

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

Treatment:

Diagnostic Test: Protein S activity