Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-10 @ 10:01 AM
Study NCT ID:
NCT03670758
Status:
UNKNOWN
Last Update Posted:
2018-09-14
First Post:
2018-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein S Activity in Women With Unexplained Infertility
Sponsor:
Esraa Gamal Ahmed
Organization:
Study Overview
Official Title:
Protein S Activity in Women With Unexplained Infertility
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: