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

NCT01019785 | Unknown Phase 3 DMC

• 1 other identifier: Delivery2009
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Complication

Keywords

Pregnancy rate (pos test, live fetus at 12 weeks, baby home); Pregnancy complication (Pregnancy hypertension, SGA, diab); Thrombin generation

Outcome Measures

Primary Outcomes (1)

• Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate

  4 weeks to 9 month

Secondary Outcomes (1)

• Pregnancy complications (pregnancy hypertension, SGA, diabetes)

  9 months

Study Arms (2)

High dose Vitamin D

ACTIVE COMPARATOR

Dietary Supplement: Ergocalciferol

Low dose Vitamin D

SHAM COMPARATOR

Dietary Supplement: Ergocalciferol

Interventions

Ergocalciferol DIETARY_SUPPLEMENT

100 000 U drops is given once

Also known as: Made by the Swedish APOTEKET

High dose Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women initiating IVF treatment

You may not qualify if:

• Women that have entered the study before

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

IVF Unit Karolinska University Hospital, Huddinge

Huddinge, 14186, Sweden

Location

Related Publications (3)

• Epstein E, Lindqvist PG, Geppert B, Olsson H. A population-based cohort study on sun habits and endometrial cancer. Br J Cancer. 2009 Aug 4;101(3):537-40. doi: 10.1038/sj.bjc.6605149. Epub 2009 Jun 23.

  PMID: 19550419 BACKGROUND

• Lindqvist PG, Epstein E, Olsson H. Does an active sun exposure habit lower the risk of venous thrombotic events? A D-lightful hypothesis. J Thromb Haemost. 2009 Apr;7(4):605-10. doi: 10.1111/j.1538-7836.2009.03312.x.

  PMID: 19335448 BACKGROUND

• Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.

  PMID: 32851663 DERIVED

MeSH Terms

Conditions

Pregnancy Complications; Hypertension, Pregnancy-Induced

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

SE (1)