NCT02341365

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

November 7, 2014

Last Update Submit

January 16, 2015

Conditions

Keywords

Egg donationvitaminDovarian reserveovarian stimulation

Outcome Measures

Primary Outcomes (1)

  • Numbers of oocytes retrieved

    2 months

Secondary Outcomes (5)

  • implantation rate

    2 months

  • pregnancy rate

    2 months

  • AFC

    2 months

  • number of mature oocytes

    2 months

  • AMH

    2 months

Interventions

observational study of 269 donnors

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

oocytes' donors who underwent ovarian stimulation cycles in our clinic from June 2013 to April 2014

You may qualify if:

  • 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

You may not qualify if:

  • current or past exposure to radiation or hazardous chemical substances,
  • history of drug use,
  • family history of hereditary chromosomal diseases,
  • sexually transmitted diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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

    RESULT

Study Officials

  • Juan Antonio García Velasco, Professor

    IVI Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

January 19, 2015

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 19, 2015

Record last verified: 2015-01