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

Vitamin D Supplementation on Assisted Reproduction Technology (ART) outcomes: a randomized clinical controlled trial and an investigation of the involved biological mechanisms - VITAMIND AND IN VITRO FERTILIZATION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004233-27-IT

Enrollment

630

Registered

2017-11-22

Start date

2016-06-23

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

in vitro fertilization MedDRA version: 20.0 Level: PT Classification code 10056204 Term: In vitro fertilisation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: DIBASE - 300.000 UI/ML SOLUZIONE INIETTABILE PER USO ORALE E INTRAMUSCOLARE 2 FIALE 1 ML Product Name: COLICALCIFEROLO-VITAMINA D3 Product Code: VITAMINA D Pharmaceutical Form: Oral sol

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Italy

Contacts

Public ContactU.O.S.D. CENTRO P.M.A.

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO

centrosterilita@policlinico.mi.it0255036582

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026