Unexplained Female InfertilityNCT03670758
Protein S Activity in Women With Unexplained Infertility
An observational study of Unexplained Female Infertility, run by Esraa Gamal Ahmed.
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?. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unexplained Female Infertility
- What is being tested?
- Protein S activity
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2018to 5 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Age: 18 - 35 years old.
- Normal husband's semen analysis, (WHO criteria):
- Count ≥ 15 million/ml.
- Motility: ≥ 40%
- Morphology: ≥ 4% normal morphology.
- Documented ovulation.
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- Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.
- Patent Fallopian tubes.
- Normal uterine cavity.
- -
Who cannot join
- Patients aged less than 18 years or more than 35 years old.
- Secondary infertility
- Presence of male factor infertility
- Anovulatory cycles.
- Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.
- Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)
- Patients with recurrent abortion. -
About this study
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.
Read the detailed description
- Type of Study: Case Control Study.
- Study Setting: Ain Shams University Maternity Hospital: outpatient Infertility clinic and outpatient gynecology clinic.
- 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:
- Age: 18 - 35 years old.
- Normal husband's semen analysis, (WHO criteria):
- Count ≥ 15 million/ml.
- Motility: ≥ 40%
- Morphology: ≥ 4% normal morphology.
- Documented ovulation.
- Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.
- Patent Fallopian tubes.
- Normal uterine cavity.
Exclusion criteria:
- Patients aged less than 18 years or more than 35 years old.
- Secondary infertility
- Presence of male factor infertility
- Anovulatory cycles.
- Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.
- Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)
- Patients with recurrent abortion.
- Conditions
- Unexplained Female Infertility
- Being tested
- Protein S activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein S activityDiagnostic test
Intravenous blood sample
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic Receives: Diagnostic Test: Protein S activity | |
| 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 Receives: Diagnostic Test: Protein S activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein S activity
venous blood sample
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start5 Sep 2018 (estimated)
- Primary completion5 Sep 2018
- Study completion5 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Gamal Ahmed
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Responsible party
- Sponsor-investigator, Esraa Gamal Ahmed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670758
- Sponsor's protocol ID
- AinShamsMH EAhmed
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein S Activity in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03670758
- Acronym / sponsor ID
- AinShamsMH EAhmed
- Conditions
- Unexplained Female Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Esraa Gamal AhmedUniversity, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Study start
- 5 Sep 2018 (estimated)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Type of Study: Case Control Study.
- Study Setting: Ain Shams University Maternity Hospital: outpatient Infertility clinic and outpatient gynecology clinic.
- 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:
- Age: 18 - 35 years old.
- Normal husband's semen analysis, (WHO criteria):
- Count ≥ 15 million/ml.
- Motility: ≥ 40%
- Morphology: ≥ 4% normal morphology.
- Documented ovulation.
- Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.
- Patent Fallopian tubes.
- Normal uterine cavity.
Exclusion criteria:
- Patients aged less than 18 years or more than 35 years old.
- Secondary infertility
- Presence of male factor infertility
- Anovulatory cycles.
- Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.
- Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)
- Patients with recurrent abortion.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Protein S activityWill include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic |
| Group 2 | – | Diagnostic Test: Protein S activityanother 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (10 listed)
- Age: 18 - 35 years old.
- Normal husband's semen analysis, (WHO criteria):
- Documented ovulation.
- Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.
- Patent Fallopian tubes.
Key exclusion criteria (7 listed)
- Patients aged less than 18 years or more than 35 years old.
- Secondary infertility
- Presence of male factor infertility
- Anovulatory cycles.
- Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein S activityIntravenous blood sample | Diagnostic test | Group 1, Group 2 |
Primary outcome
Protein S activity
Time frame: six months
venous blood sample
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexplained Female Infertility, run by Esraa Gamal Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein S activity (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.