Case Control StudyInfertilityNCT03396237
Vitamin D Deficiency Among Women With Unexplained Infertility
An observational study of Case Control Study, run by Ain Shams Maternity Hospital.
Trial summary
Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not? Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Case Control Study
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2018to 1 Aug 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Mid aged women with unexplained infertility group and another fertile group to compare vitamin D inbetween them
Who may be able to join
- women with unexplained infertility.
- pregnant fertile women as control group.
Who cannot join
- • Endocrinopathies such as (diabetes mellitus, thyroid disorders, parathyroid disorders and hyperprolactinemia), cardiovascular related diseases, severe infection, malignancies and concomitant diseases contribute to Vit D deficiency.
- Women with ovulatory factor like PCOS,anovulation and poor ovarian reserve are excluded.
- Women with endometriosis are excluded.
- Women with autoimmune diseases like antiphospholipid antibodies or lupus erythematosus are excluded.
- Documented uterine anomalies, tubal factor, cervical factor and other local causes of infertility.
- Male factor of infertility is excluded.
- Bone and metabolic disease, liver diseases and kidney related diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?
Read the detailed description
The study will be done on women with unexplained infertility as a case group and fertile pregnant women as control group to detect if there's a difference in serum level of vitamin D between two groups which will help in the future for curing unexplained infertility women.
- Conditions
- Case Control Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Case group contain cases of unexplained infertility women | |
| Group B | Control group contain fertile pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level
Serum vitamin D level in women with unexplained infertility and fertile pregnant women.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start10 Jan 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Case Control StudyStudies 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
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
- Investigators
- Hassan T Khairy, Professor, Study director, Hassan tawfek office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396237
- Sponsor's protocol ID
- Vitamin D and Infertility
- Acronym
- Infertility
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency Among Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT03396237
- Acronym / sponsor ID
- Infertility / Vitamin D and Infertility
- Conditions
- Case Control Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 10 Jan 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.
Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?
Detailed description
The study will be done on women with unexplained infertility as a case group and fertile pregnant women as control group to detect if there's a difference in serum level of vitamin D between two groups which will help in the future for curing unexplained infertility women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Case group contain cases of unexplained infertility women |
| Group B | – | –Control group contain fertile pregnant women |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Mid aged women with unexplained infertility group and another fertile group to compare vitamin D inbetween them
Key inclusion criteria (2 listed)
- women with unexplained infertility.
- pregnant fertile women as control group.
Key exclusion criteria (7 listed)
- • Endocrinopathies such as (diabetes mellitus, thyroid disorders, parathyroid disorders and hyperprolactinemia), cardiovascular related diseases, severe infection, malignancies and concomitant diseases contribute to Vit D deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D level
Time frame: 6 months
Serum vitamin D level in women with unexplained infertility and fertile pregnant women.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
Hassan T Khairy, Professor study director
Hassan tawfek office
Questions about this trial
What is this clinical trial studying?
An observational study of Case Control Study, run by Ain Shams Maternity Hospital.
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 2 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 10 Jan 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?
Contact Sobhy R Mohammed, MBBCH (01003815460 ext. 002, Sobhyrawy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D level (time frame: 6 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 10 Jan 2018.