Impact of Vitamine D Status on in Vitro Fertilization Outcomes

NCT05048511 | Withdrawn

• 1 other identifier: RC16_0122
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility

Keywords

Vitamin D, 25(OH)D; in vitro fertilization; AMH; infertility; clinical pregnancy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The relationship between serum vitamin D levels and the ovarian reserve marker AMH

  day 3

Study Arms (2)

Normal

Women with sufficient vitamin D level, when 25(OH)D \>20 ng/ml

Biological: vitamin D estimation

Deficient

women deficiency vitamin D level, when 25(OH)D \<20 ng/ml

Biological: vitamin D estimation

Interventions

vitamin D estimation BIOLOGICAL

Serum samples to estimate vitamin D status were collected on the sixth day of stimulation

Deficient; Normal

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Related Publications (7)

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

  PMID: 17634462 BACKGROUND

• 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.

  PMID: 18694980 BACKGROUND

• 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.

  PMID: 7400847 BACKGROUND

• 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.

  PMID: 16720713 BACKGROUND

• 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.

  PMID: 16957024 BACKGROUND

• 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.

  PMID: 24628555 BACKGROUND

• 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.

  PMID: 22047005 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Sophie DUBOURDIEU, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: September 17, 2021
• Study Start: January 1, 2016
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 27, 2021

Record last verified: 2021-09