InfertilityNCT02987478
Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection
An observational study of Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
All patients will undergo in vitro fertilization. Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval. Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Dec 2017
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Age between 20 and 35 years old. * Body mass index between 20 - 30. * Unexplained infertility . * Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3). * Normal hysteroscopy . * Fresh embryo transfer of 2 or more blastocysts stage. * Embryo transfer on day 5 after fertilization
Who may be able to join
- Age between 20 and 35 years old.
- Body mass index between 20 - 30.
- Unexplained infertility .
- Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).
- Normal hysteroscopy ( healthy uterus with no fibroids or other growths)
- Fresh embryo transfer of 2 or more blastocysts stage.
- Embryo transfer on day 5 after fertilization
Who cannot join
- Women younger than 20 years old or older than 35 years old.
- Previous one or more failed IVF.
- Uncorrected congenital or acquired uterine anomalies.
- Other causes of infertility rather than unexplained infertility.
- Less than 2 embryo transfer, cleavage stager frozen embryo transfer.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo, Abbassia, 11566
Moh Samy, MD, 201002554281, dr_hend_kamal@yahoo.com
Mohammed Samy, MD, +20100 194 7488
About this study
All patients will undergo in vitro fertilization.
Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.
Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.
Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.
clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.
Read the detailed description
PATIENTS AND METHODS
Protocol Outline:
The Study:
Study site:
Ain Shams University Maternity Hospital.
Study Design:
A prospective Cohort study.
Study setting:
The study will be conducted at Ain Shams University Maternity Hospital.
Study population:
The study will include all women planned to undergo IVF due to unexplained infertility.
Methodology:
The study will be approved by the hospital ethics committee.
All included women will undergo the following:
- History taking.
- General and abdominal examination.
- Vaginal examination and assessment
- Pelvic ultrasound.
- Routine laboratory investigations including complete blood picture, hematocrit, liver and kidney function tests and coagulation profile.
- Preoperative senior anesthetist assessment.
- Hysteroscopy.
All patients will undergo IVF.
Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.
Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.
Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.
clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.
Measurement of Outcomes
- serum 25 (OH) D levels.
- Number of oocyte. Most studies put the optimal number of retrieved oocytes between 10 and 15.
- The implantation rate: Calculated as the number of gestational sacs observed by ultrasound divided by the number of embryos transferred, multiplied by 100.
- Number of gestational sac.
- Conditions
- Infertility
- Keywords
- Vitamin D following intra cytoplasmic sperm injection
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Measured: 4-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Sayed Abdul-hafeez, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987478
- Sponsor's protocol ID
- 6789
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT02987478
- Acronym / sponsor ID
- 6789
- Conditions
- Infertility
- Keywords
- Vitamin D following intra cytoplasmic sperm injection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- 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.
All patients will undergo in vitro fertilization.
Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.
Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.
Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.
clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.
Detailed description
PATIENTS AND METHODS
Protocol Outline:
The Study:
Study site:
Ain Shams University Maternity Hospital.
Study Design:
A prospective Cohort study.
Study setting:
The study will be conducted at Ain Shams University Maternity Hospital.
Study population:
The study will include all women planned to undergo IVF due to unexplained infertility.
Methodology:
The study will be approved by the hospital ethics committee.
All included women will undergo the following:
- History taking.
- General and abdominal examination.
- Vaginal examination and assessment
- Pelvic ultrasound.
- Routine laboratory investigations including complete blood picture, hematocrit, liver and kidney function tests and coagulation profile.
- Preoperative senior anesthetist assessment.
- Hysteroscopy.
All patients will undergo IVF.
Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.
Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.
Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.
clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.
Measurement of Outcomes
- serum 25 (OH) D levels.
- Number of oocyte. Most studies put the optimal number of retrieved oocytes between 10 and 15.
- The implantation rate: Calculated as the number of gestational sacs observed by ultrasound divided by the number of embryos transferred, multiplied by 100.
- Number of gestational sac.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Age between 20 and 35 years old. * Body mass index between 20 - 30. * Unexplained infertility . * Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3). * Normal hysteroscopy . * Fresh embryo transfer of 2 or more blastocysts stage. * Embryo transfer on day 5 after fertilization
Key inclusion criteria (7 listed)
- Age between 20 and 35 years old.
- Body mass index between 20 - 30.
- Unexplained infertility .
- Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).
- Normal hysteroscopy ( healthy uterus with no fibroids or other growths)
Key exclusion criteria (5 listed)
- Women younger than 20 years old or older than 35 years old.
- Previous one or more failed IVF.
- Uncorrected congenital or acquired uterine anomalies.
- Other causes of infertility rather than unexplained infertility.
- Less than 2 embryo transfer, cleavage stager frozen embryo transfer.
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
pregnancy
Time frame: 4-5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 7 inclusion and 5 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 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohammed Samy, MD (+20100 194 7488, dr_hend_kamal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy (time frame: 4-5 weeks). 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 9 Dec 2016.