Clinical trial NCT02341365: Vitamin D Influence on Oocyte Donation
Official title: Impact of Vitamin D Levels on Ovarian Reserve and Ovarian Response to Controlled Stimulation in Egg Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Phosphate, Calcium and Vitamin D Metabolism
Female Infertility Due to Diminished Ovarian Reserve
Hormonal Requirement
Reproductive Disorder
Keywords: Egg donation
vitaminD
ovarian reserve
ovarian stimulation
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 269
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oocytes' donors who underwent ovarian stimulation cycles in our clinic from June 2013 to April 2014

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of oocytes retrieved
timeFrame: 2 months
Secondary outcomes:
measure: implantation rate
timeFrame: 2 months
measure: pregnancy rate
timeFrame: 2 months
measure: AFC
timeFrame: 2 months
measure: number of mature oocytes
timeFrame: 2 months
measure: AMH
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: IVI Madrid
name: Juan Antonio García Velasco, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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