InfertilityNCT01999608
Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients
An observational study of Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The role of vitamin D deficiency in female reproduction remains controversial. Early retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two retrospective studies postulated that vitamin D deficiency… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- How many people
- 283 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to Jun 2015
- 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: Infertile women 18-43 years old undergoing IVF/ICSI
Who may be able to join
- infertile women less than 42 years old, undergoing their first treatment cycle in our institution
Who cannot join
- vitamin D supplements, taking medication for systematic disease or having potential iatrogenic (e.g. ovarian surgery, gonadotoxic therapy) or known genetic cause of ovarian loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients. A Cross-sectional Analysis
The role of vitamin D deficiency in female reproduction remains controversial. Early retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium.
Taking into account that knock-out experiments have shown that vitamin D receptor null mice not only experience uterine hypoplasia but also impaired folliculogenesis, it might be hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian reserve. This may be further supported by previous reports demonstrating that serum 25-OH Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age.
The aim of this study is to examine through a large set of prospectively recruited infertile women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).
- Conditions
- Infertility
- Keywords
- Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D deficient patients | Serum 25-OH Vitamin D levels <20ng/L | |
| Vitamin D sufficient patients | Serum 25-OH Vitamin D levels ≥20ng/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimullerian hormone values in relation to vitamin D status
On the day of the preliminary testing (irrespective of the day of the menstrual cycle) patients will have their serum 25-OH-vitamin D and antimullerian hormone levels determined. 25-OH-vitamin D and antimullerian hormone levels will be measured in samples retrieved on the same day
Measured: Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)
Antral follicle count in relation to vitamin D status
On the following cycle of the measurement of serum 25-OH-Vitamin D and AMH levels patient will have a transvaginal ultrasound to determine the antral follicle count (AFC)
Measured: 2nd-3rd day of the menstrual cycle following the determination of vitamin D levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel
- Investigators
- Nikolaos P. Polyzos, MD PhD, Principal investigator, Universitair Ziekenhuis BrusselArne Van de Vijver, MD, Principal investigator, UZBrussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999608
- Sponsor's protocol ID
- 2013/180
- Status last verified
- Jun 2016
- First submitted
- 18 Nov 2013
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ozkan S, Jindal S, Greenseid K, Shu J, Zeitlian G, Hickmon C, Pal L. Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertil Steril. 2010 Sep;94(4):1314-1319. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8.
PubMed 19589516Anifandis GM, Dafopoulos K, Messini CI, Chalvatzas N, Liakos N, Pournaras S, Messinis IE. Prognostic value of follicular fluid 25-OH vitamin D and glucose levels in the IVF outcome. Reprod Biol Endocrinol. 2010 Jul 28;8:91. doi: 10.1186/1477-7827-8-91.
PubMed 20667111Aleyasin A, Hosseini MA, Mahdavi A, Safdarian L, Fallahi P, Mohajeri MR, Abbasi M, Esfahani F. Predictive value of the level of vitamin D in follicular fluid on the outcome of assisted reproductive technology. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):132-7. doi: 10.1016/j.ejogrb.2011.07.006. Epub 2011 Aug 10.
PubMed 21835540Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.
PubMed 22914766Rudick BJ, Ingles SA, Chung K, Stanczyk FZ, Paulson RJ, Bendikson KA. Influence of vitamin D levels on in vitro fertilization outcomes in donor-recipient cycles. Fertil Steril. 2014 Feb;101(2):447-52. doi: 10.1016/j.fertnstert.2013.10.008. Epub 2013 Nov 5.
PubMed 24210230Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16.
PubMed 22508713Merhi ZO, Seifer DB, Weedon J, Adeyemi O, Holman S, Anastos K, Golub ET, Young M, Karim R, Greenblatt R, Minkoff H. Circulating vitamin D correlates with serum antimullerian hormone levels in late-reproductive-aged women: Women's Interagency HIV Study. Fertil Steril. 2012 Jul;98(1):228-34. doi: 10.1016/j.fertnstert.2012.03.029. Epub 2012 Apr 10.
PubMed 22494925Yoshizawa T, Handa Y, Uematsu Y, Takeda S, Sekine K, Yoshihara Y, Kawakami T, Arioka K, Sato H, Uchiyama Y, Masushige S, Fukamizu A, Matsumoto T, Kato S. Mice lacking the vitamin D receptor exhibit impaired bone formation, uterine hypoplasia and growth retardation after weaning. Nat Genet. 1997 Aug;16(4):391-6. doi: 10.1038/ng0897-391.
PubMed 9241280
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients. A Cross-sectional Analysis
- ClinicalTrials.gov ID
- NCT01999608
- Acronym / sponsor ID
- 2013/180
- Conditions
- Infertility
- Keywords
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Dec 2013 (estimated)
- 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.
The role of vitamin D deficiency in female reproduction remains controversial. Early retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium.
Taking into account that knock-out experiments have shown that vitamin D receptor null mice not only experience uterine hypoplasia but also impaired folliculogenesis, it might be hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian reserve. This may be further supported by previous reports demonstrating that serum 25-OH Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age.
The aim of this study is to examine through a large set of prospectively recruited infertile women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficient patients | – | –Serum 25-OH Vitamin D levels <20ng/L |
| Vitamin D sufficient patients | – | –Serum 25-OH Vitamin D levels ≥20ng/L |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women 18-43 years old undergoing IVF/ICSI
Key inclusion criteria (1 listed)
- infertile women less than 42 years old, undergoing their first treatment cycle in our institution
Key exclusion criteria (1 listed)
- vitamin D supplements, taking medication for systematic disease or having potential iatrogenic (e.g. ovarian surgery, gonadotoxic therapy) or known genetic cause of ovarian loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antimullerian hormone values in relation to vitamin D status
Time frame: Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)
On the day of the preliminary testing (irrespective of the day of the menstrual cycle) patients will have their serum 25-OH-vitamin D and antimullerian hormone levels determined. 25-OH-vitamin D and antimullerian hormone levels will be measured in samples retrieved on the same day
Antral follicle count in relation to vitamin D status
Time frame: 2nd-3rd day of the menstrual cycle following the determination of vitamin D levels
On the following cycle of the measurement of serum 25-OH-Vitamin D and AMH levels patient will have a transvaginal ultrasound to determine the antral follicle count (AFC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Background: PubMed 19589516Ozkan S, Jindal S, Greenseid K, Shu J, Zeitlian G, Hickmon C, Pal L. Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertil Steril. 2010 Sep;94(4):1314-1319. doi: 10.1016/j.fertnstert.2009.05.019. Epub 2009 Jul 8.
- Background: PubMed 20667111Anifandis GM, Dafopoulos K, Messini CI, Chalvatzas N, Liakos N, Pournaras S, Messinis IE. Prognostic value of follicular fluid 25-OH vitamin D and glucose levels in the IVF outcome. Reprod Biol Endocrinol. 2010 Jul 28;8:91. doi: 10.1186/1477-7827-8-91.
- Background: PubMed 21835540Aleyasin A, Hosseini MA, Mahdavi A, Safdarian L, Fallahi P, Mohajeri MR, Abbasi M, Esfahani F. Predictive value of the level of vitamin D in follicular fluid on the outcome of assisted reproductive technology. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):132-7. doi: 10.1016/j.ejogrb.2011.07.006. Epub 2011 Aug 10.
- Background: PubMed 22914766Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.
- Background: PubMed 24210230Rudick BJ, Ingles SA, Chung K, Stanczyk FZ, Paulson RJ, Bendikson KA. Influence of vitamin D levels on in vitro fertilization outcomes in donor-recipient cycles. Fertil Steril. 2014 Feb;101(2):447-52. doi: 10.1016/j.fertnstert.2013.10.008. Epub 2013 Nov 5.
- Background: PubMed 22508713Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16.
- Background: PubMed 22494925Merhi ZO, Seifer DB, Weedon J, Adeyemi O, Holman S, Anastos K, Golub ET, Young M, Karim R, Greenblatt R, Minkoff H. Circulating vitamin D correlates with serum antimullerian hormone levels in late-reproductive-aged women: Women's Interagency HIV Study. Fertil Steril. 2012 Jul;98(1):228-34. doi: 10.1016/j.fertnstert.2012.03.029. Epub 2012 Apr 10.
- Background: PubMed 9241280Yoshizawa T, Handa Y, Uematsu Y, Takeda S, Sekine K, Yoshihara Y, Kawakami T, Arioka K, Sato H, Uchiyama Y, Masushige S, Fukamizu A, Matsumoto T, Kato S. Mice lacking the vitamin D receptor exhibit impaired bone formation, uterine hypoplasia and growth retardation after weaning. Nat Genet. 1997 Aug;16(4):391-6. doi: 10.1038/ng0897-391.
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.
Nikolaos P. Polyzos, MD PhD principal investigator
Universitair Ziekenhuis Brussel
Arne Van de Vijver, MD principal investigator
UZBrussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antimullerian hormone values in relation to vitamin D status (time frame: Between 0-28 days prior to having their 1st ultrasound scan for the determination of antral follicle count (AFC)). The study lists 2 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 NCT01999608, which also lists 8 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 2 Jun 2016.