Impact of Vitamine D Status on in Vitro Fertilization Outcomes

Withdrawn

• Conditions: Infertility
• Interventions: Biological: vitamin D estimation

• Registration Number: NCT05048511
• Lead Sponsor: Nantes University Hospital

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-01-01
• Study Completion: 2016-01-01
• Study First Submitted: 2016-05-09
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-17
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	vitamin D estimation	Women with sufficient vitamin D level, when 25(OH)D \>20 ng/ml
Deficient	vitamin D estimation	women deficiency vitamin D level, when 25(OH)D \<20 ng/ml

Primary Outcome Measures

Name	Time	Method
Laboratory pregnancy	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	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	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 Outcome Measures

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