Protein S Activity in Women With Unexplained Infertility

Unexplained Female Infertility Clinical Trial

Official title:

Protein S Activity in Women With Unexplained Infertility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03670758
• Other study ID #: AinShamsMH EAhmed
• Status: Not yet recruiting
• Start date: September 5, 2018
• Est. completion date: September 5, 2018

Study information

• Verified date: September 2018
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 speci?cally excluded.

6. Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)

7. Patients with recurrent abortion. -

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Unexplained Female Infertility

Intervention

Diagnostic Test:
• Protein S activity
Intravenous blood sample

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Esraa Gamal Ahmed	Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein S activity	venous blood sample	six months