Clinical trial NCT05048511: Impact of Vitamine D Status on in Vitro Fertilization Outcomes
Official title: Evaluation of the Impact of Vitamine D Status on in Vitro Fertilization Outcomes in a Large Population of Infertile Women.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Keywords: Vitamin D, 25(OH)D
in vitro fertilization
AMH
infertility
clinical pregnancy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Laboratory pregnancy
timeFrame: 4 weeks to 9 month
measure: Clinical pregnancy
timeFrame: 4 weeks to 9 month
measure: Live birth
timeFrame: 4 weeks to 9 month
Secondary outcomes:
measure: The relationship between serum vitamin D levels and the ovarian reserve marker AMH
timeFrame: day 3
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Sophie DUBOURDIEU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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