Vitamin D Influence on Oocyte Donation

Reproductive Disorder Clinical Trial

Official title:

Impact of Vitamin D Levels on Ovarian Reserve and Ovarian Response to Controlled Stimulation in Egg Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341365
• Other study ID #: 1406-MAD-035-JG
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: January 16, 2015
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: CEIC Puerta hierro
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Other:
• vitamin D,AMH, AFC, reproductive outcome egg recipients
observational study of 269 donnors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of oocytes retrieved		2 months	Yes
Secondary	implantation rate		2 months	Yes
Secondary	pregnancy rate		2 months	Yes
Secondary	AFC		2 months	Yes
Secondary	number of mature oocytes		2 months	Yes
Secondary	AMH		2 months	Yes