- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341365
Vitamin D Influence on Oocyte Donation
January 16, 2015 updated by: IVI Madrid
Impact of Vitamin D Levels on Ovarian Reserve and Ovarian Response to Controlled Stimulation in Egg Donors
Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin D, ovarian reserve and ovarian response to controlled stimulation in egg donors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Design: Retrospective study.
Setting: University affiliated private IVF center.
Intervention: Serum analysis of vitamin D, bioavailable vitamin D, antimullerian hormone (AMH), antral follicular count (AFC), reproductive outcome of oocytes recipients Main outcome measure: AMH, AFC, number of oocytes retrieved and number of mature oocytes, pregnancy and implantation rate of donated oocytes'recipients.
Study Type
Observational
Enrollment (Actual)
269
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 34 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
oocytes' donors who underwent ovarian stimulation cycles in our clinic from June 2013 to April 2014
Description
Inclusion Criteria:
- Caucasian race,
- between 18 and 34 years of age,
- all donors had normal menstrual cycles of 26-34 days,
- normal weight range (BMI 18- 25 Kg/m2),
- normal uterus and ovaries on transvaginal ultrasound (no signs of polycystic ovarian syndrome), and
- an antral follicle count (AFC) >10,
- normal karyotype
Exclusion Criteria:
- current or past exposure to radiation or hazardous chemical substances,
- history of drug use,
- family history of hereditary chromosomal diseases,
- sexually transmitted diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Numbers of oocytes retrieved
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
implantation rate
Time Frame: 2 months
|
2 months
|
pregnancy rate
Time Frame: 2 months
|
2 months
|
AFC
Time Frame: 2 months
|
2 months
|
number of mature oocytes
Time Frame: 2 months
|
2 months
|
AMH
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juan Antonio García Velasco, Professor, IVI Madrid
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holick MF et al. Endocrine Society. Evaluation, treatment, prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1911-1930 Rudick B et al. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012;27:3321-7 Polyzos NP et al. Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Hum Reprod. 2014;29:2032-40 Franasiak JM et al. Vitamin D levels do not affect IVF outcomes following the transfer of euploid blastocysts. Am J Obstet Gynecol 2014;211:x.ex-x.ex Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fertil Steril. 2014. Irani M, Merhi Z. Role of vitamin D in ovarian physiology and its implication in reproduction: a systematic review. Fertil Steril. 2014 ;102:460-468
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 7, 2014
First Submitted That Met QC Criteria
January 16, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 16, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1406-MAD-035-JG
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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