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.

Study Overview

• Status: Unknown
• Conditions: Unexplained Female Infertility
• Intervention / Treatment: Diagnostic test: Protein S activity

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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).

Description

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. -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic	Diagnostic test: Protein S activity; Intravenous blood sample
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	Diagnostic test: Protein S activity; Intravenous blood sample

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Esraa Gamal Ahmed
• Collaborators: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 5, 2018
• Primary Completion (ACTUAL): September 5, 2018
• Study Completion (ANTICIPATED): September 5, 2018

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Anticoagulants; Protein S
• Other Study ID Numbers: AinShamsMH EAhmed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No