- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02987478
Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohammed Samy, MD
- Phone Number: +20100 194 7488
- Email: dr_hend_kamal@yahoo.com
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 11566
- Recruiting
- Ain shams university maternity hospital
-
Contact:
- Moh Samy, MD
- Phone Number: 201002554281
- Email: dr_hend_kamal@yahoo.com
-
Contact:
- Mohammed Samy, MD
- Phone Number: +20100 194 7488
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pregnancy
Time Frame: 4-5 weeks
|
4-5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6789 (CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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