Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial (Delivery)

Karolinska University Hospital

Status and phase: Unknown; Phase 3

Conditions: Pregnancy Complication

Treatments: Dietary Supplement: Ergocalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01019785

Delivery2009

Details and patient eligibility

About

During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All women initiating IVF treatment

Exclusion criteria

• Women that have entered the study before

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

High dose Vitamin D

Active Comparator group

Treatment:

Dietary Supplement: Ergocalciferol

Dietary Supplement: Ergocalciferol

Low dose Vitamin D

Sham Comparator group

Treatment:

Dietary Supplement: Ergocalciferol

Dietary Supplement: Ergocalciferol