Vitamin D Supplementation on Assisted Reproduction Technology (ART) outcomes: arandomized clinical controlled trial and an investigation of the involved biological mechanisms

Phase 1

• Conditions: in vitro fertilization; MedDRA version: 20.0Level: PTClassification code 10056204Term: In vitro fertilisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2015-004233-27-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-22
• Study Completion: 2019-12-31
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 630

Inclusion Criteria

1) women with indication to IVF;
2) age 18-39 years
3) less then 3 previous IVF cycles
4) BMI 18-25.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 630
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) reduced ovarian reserve (AMH < 0.5 ug/l);
2) frozen/thawing cycles
3) surgical origin of spermatozoa;
4) chronical diseases.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the study aims at determining the potential benefits of vitamin D supplementation in improving clinical pregnancy rate in womenundergoing ART;Secondary Objective: to investigate wether vitamin D supplementation might improve clinical and embryological parameters such as: number of cancelled cycles, number of avaible oocytes, number of good quality embryos, units of FSHadministered per retrieved oocyte, implantation rate of transferred embryos. To investigate the effect of vitamin D supplementation on oocyte and endometrium quality at a molecular level through a comparative analysis between treated and untreated patients based on the analysis af cumulus cells, follicular and endometrial fluids.;Primary end point(s): clinical pregnancy rate per oocyte retrieval after the first embryo transfer.;Timepoint(s) of evaluation of this end point: 10 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): delivery rate and obstetric outcome ;Timepoint(s) of evaluation of this end point: 1 year after embryo transfer