Impact of Vitamine D Status on in Vitro Fertilization Outcomes (DFIV)

Evaluation of the Impact of Vitamine D Status on in Vitro Fertilization Outcomes in a Large Population of Infertile Women.

Non skeletal effect of vitamin D have been the focus of much interest in the past decade. During the last years, special attention has been given to the impact of vitamin D on human reproduction. Its receptor is expressed in most reproductive organs including hypothalamus, pituitary gland, uterus, ovary, mammary gland and the placenta. In vitro experiments suggest that vitamin D would be involved in regulated embryo-implantation. Concerning AMH, vitamin D seems to alters AMH signaling in human granulosa cells although their circulated levels are correlated in lated reproductive aged women. The results of precedents studies about the impact of vitamin D on IVF outcomes remain conflicting The aim of our study was to assess in a large unselected population of infertile women, the impact of vitamin D deficiency on IVF outcome and to examine the relationship between serum vitamin D levels and the ovarian reserve marker AMH.

Study Overview

• Status: Withdrawn
• Conditions: Infertility
• Intervention / Treatment: Biological: vitamin D estimation

Detailed Description

Vitamin D was measured on the sixth day of stimulation. According to vitamin D level, women were divided into 2 groups (deficiency when 25(OH)D <20 ng/ml and sufficient when 25(OH)D >20 ng/ml).

Pregnancy rates were compared among these two groups after controlling age, BMI, characteristics of ovarian stimulation, number of ovocytes obtains, etc.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

population of infertile women undergoing IVF/ICSI in the center of medical assistance for the procreation of the french hospital of Nantes between september 2010 and may 2011.

Description

Inclusion Criteria:

• Patients undergoing IVF/ICSI in the center of medical assistance for the procreation of the french hospital of Nantes between september 2010 and may 2011.

Exclusion Criteria:

• Women for who the cycle was interrupted during ovarian stimulation or converted in intrauterine insemination.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal; Women with sufficient vitamin D level, when 25(OH)D >20 ng/ml	Biological: vitamin D estimation; Serum samples to estimate vitamin D status were collected on the sixth day of stimulation
Deficient; women deficiency vitamin D level, when 25(OH)D <20 ng/ml	Biological: vitamin D estimation; Serum samples to estimate vitamin D status were collected on the sixth day of stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory pregnancy	Serum HCG was drawn 16 days after ovocyte tapping; Patient had a repeat bHCG drawn 48 hours if they have a positive result from the first bHCG; Clinical pregnancy was defined as ultrasound documentation of fetal heart tones at seven weeks of gestation	4 weeks to 9 month
Clinical pregnancy	Serum HCG was drawn 16 days after ovocyte tapping; Patient had a repeat bHCG drawn 48 hours if they have a positive result from the first bHCG; Clinical pregnancy was defined as ultrasound documentation of fetal heart tones at seven weeks of gestation	4 weeks to 9 month
Live birth	Serum HCG was drawn 16 days after ovocyte tapping; Patient had a repeat bHCG drawn 48 hours if they have a positive result from the first bHCG; Clinical pregnancy was defined as ultrasound documentation of fetal heart tones at seven weeks of gestation	4 weeks to 9 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between serum vitamin D levels and the ovarian reserve marker AMH	Serum AMH was drawn during hormonal examination on third day of natural cycle.	day 3

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Sophie DUBOURDIEU, Dr, Nantes University Hospital

Publications and helpful links

General Publications

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
• Halloran BP, DeLuca HF. Effect of vitamin D deficiency on fertility and reproductive capacity in the female rat. J Nutr. 1980 Aug;110(8):1573-80. doi: 10.1093/jn/110.8.1573.
• Bouillon R, Carmeliet G, Verlinden L, van Etten E, Verstuyf A, Luderer HF, Lieben L, Mathieu C, Demay M. Vitamin D and human health: lessons from vitamin D receptor null mice. Endocr Rev. 2008 Oct;29(6):726-76. doi: 10.1210/er.2008-0004. Epub 2008 Aug 11.
• Vigano P, Lattuada D, Mangioni S, Ermellino L, Vignali M, Caporizzo E, Panina-Bordignon P, Besozzi M, Di Blasio AM. Cycling and early pregnant endometrium as a site of regulated expression of the vitamin D system. J Mol Endocrinol. 2006 Jun;36(3):415-24. doi: 10.1677/jme.1.01946.
• Evans KN, Nguyen L, Chan J, Innes BA, Bulmer JN, Kilby MD, Hewison M. Effects of 25-hydroxyvitamin D3 and 1,25-dihydroxyvitamin D3 on cytokine production by human decidual cells. Biol Reprod. 2006 Dec;75(6):816-22. doi: 10.1095/biolreprod.106.054056. Epub 2006 Sep 6.
• Merhi Z, Doswell A, Krebs K, Cipolla M. Vitamin D alters genes involved in follicular development and steroidogenesis in human cumulus granulosa cells. J Clin Endocrinol Metab. 2014 Jun;99(6):E1137-45. doi: 10.1210/jc.2013-4161. Epub 2014 Mar 14.
• Grundmann M, von Versen-Hoynck F. Vitamin D - roles in women's reproductive health? Reprod Biol Endocrinol. 2011 Nov 2;9:146. doi: 10.1186/1477-7827-9-146.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: infertility; in vitro fertilization; AMH; clinical pregnancy; Vitamin D, 25(OH)D
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: RC16_0122