InfertilityDFIVNCT05048511
Impact of Vitamine D Status on in Vitro Fertilization Outcomes
An observational study of Infertility, run by Nantes University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- vitamin D estimation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Women for who the cycle was interrupted during ovarian stimulation or converted in intrauterine insemination.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- vitamin D estimation
- Keywords
- Vitamin D, 25(OH)D, in vitro fertilization, AMH, infertility, clinical pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D estimationBiological
Serum samples to estimate vitamin D status were collected on the sixth day of stimulation
| Study group | Role | What they receive |
|---|---|---|
| Normal | Women with sufficient vitamin D level, when 25(OH)D >20 ng/ml Receives: Biological: vitamin D estimation | |
| Deficient | women deficiency vitamin D level, when 25(OH)D <20 ng/ml Receives: Biological: vitamin D estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 4 weeks to 9 month
Secondary outcomes (1)
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.
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Jan 2016
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Why it stopped: The project was abandoned because of a lot of publications on the subject in the meantime and it was not considered relevant to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie DUBOURDIEU, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048511
- Sponsor's protocol ID
- RC16_0122
- Acronym
- DFIV
- Status last verified
- Sep 2021
- First submitted
- 9 May 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Bouillon 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.
PubMed 18694980Halloran 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.
PubMed 7400847Vigano 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.
PubMed 16720713Evans 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.
PubMed 16957024Merhi 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.
PubMed 24628555Grundmann 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.
PubMed 22047005
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Vitamine D Status on in Vitro Fertilization Outcomes in a Large Population of Infertile Women.
- ClinicalTrials.gov ID
- NCT05048511
- Acronym / sponsor ID
- DFIV / RC16_0122
- Conditions
- Infertility
- Keywords
- Vitamin D, 25(OH)D, in vitro fertilization, AMH, infertility, clinical pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The project was abandoned because of a lot of publications on the subject in the meantime and it was not considered relevant to continue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Biological: vitamin D estimationWomen with sufficient vitamin D level, when 25(OH)D >20 ng/ml |
| Deficient | – | Biological: vitamin D estimationwomen deficiency vitamin D level, when 25(OH)D <20 ng/ml |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women for who the cycle was interrupted during ovarian stimulation or converted in intrauterine insemination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D estimationSerum samples to estimate vitamin D status were collected on the sixth day of stimulation | Biological | Deficient, Normal |
Primary outcome
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
1 secondary outcome
The relationship between serum vitamin D levels and the ovarian reserve marker AMH
Time frame: day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Background: PubMed 18694980Bouillon 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.
- Background: PubMed 7400847Halloran 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.
- Background: PubMed 16720713Vigano 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.
- Background: PubMed 16957024Evans 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.
- Background: PubMed 24628555Merhi 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.
- Background: PubMed 22047005Grundmann 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.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie DUBOURDIEU, Dr principal investigator
Nantes University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Nantes University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory pregnancy (time frame: 4 weeks to 9 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05048511, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.