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Clinical Trials/NCT05048511
NCT05048511WithdrawnNot Applicable

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

Nantes University Hospital0 sitesStarted: January 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Laboratory pregnancy

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 42 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Laboratory pregnancy

Time Frame: 4 weeks to 9 month

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

Clinical pregnancy

Time Frame: 4 weeks to 9 month

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

Live birth

Time Frame: 4 weeks to 9 month

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

Secondary Outcomes

  • The relationship between serum vitamin D levels and the ovarian reserve marker AMH(day 3)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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