Vitamin D Influence on Oocyte Donation

NCT ID: NCT02341365

Last Updated: 2015-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

269 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Disorder of Phosphate, Calcium and Vitamin D Metabolism Female Infertility Due to Diminished Ovarian Reserve Hormonal Requirement Reproductive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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vitamin D,AMH, AFC, reproductive outcome egg recipients

observational study of 269 donnors

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Antonio GarcĂ­a Velasco, Professor

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

References

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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

Reference Type RESULT

Other Identifiers

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1406-MAD-035-JG

Identifier Type: -

Identifier Source: org_study_id

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