VITAMIN D DisordersNCT02317718
Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome
An observational study of VITAMIN D Disorders, run by Fakih IVF Fertility Center at 1 site in United Arab Emirates.
Trial summary
Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- VITAMIN D Disorders
- What is being tested?
- monitor reproductive outcome
- How many people
- 500 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Dec 2014to Jul 2015
- How long will I take part?
- 6 Months
- 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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing IVF between 20-42 years of age
Who may be able to join
- Subfertile women,
- Indication for IVF,
- 20-42 yrs of age.
Who cannot join
- Women on therapeutic supplementation for Vitamin D Deficiency,
- Recurrent high order implantation failure
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Fakihivf Fertiity Center
Abu Dhabi, Abu Dhabi Emirate, 31453
MONIKA CHAWLA, MD, 97124444107
About this study
Official title: Serum Vitamin D Level in Subfertile Women and Its Association With Ovarian Reserve and IVF Outcome.
Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .
The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .
Read the detailed description
Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .
The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .
- Conditions
- VITAMIN D Disorders
- Being tested
- monitor reproductive outcome
- Keywords
- serum vitamin D levels, IVF, ovarian reserve, 25 OHD3, pregnancy outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitor reproductive outcomeOther
| Study group | Role | What they receive |
|---|---|---|
| Normal vitamin D levels group | MORE THAN 20 NG/ML VITAMIN D LEVELS Receives: Other: monitor reproductive outcome | |
| Deficient Vitamin D GROUP | LESS THAN 20 NG/ML LEVELS Receives: Other: monitor reproductive outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 14 days post oocyte retrieval
Secondary outcomes (3)
AMH (antimullerian hormone) Levels
Measured: day 2-3 of the index cycle
AFC (antral follicle count)
Measured: DAY 2-3 OF INDEX CYCLE
Number of oocytes retreived
Measured: Two weeks from the last menstrual period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for VITAMIN D DisordersStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fakih IVF Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, monika chawla, Fakih IVF Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317718
- Sponsor's protocol ID
- VitD Study
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paffoni A, Ferrari S, Vigano P, Pagliardini L, Papaleo E, Candiani M, Tirelli A, Fedele L, Somigliana E. Vitamin D deficiency and infertility: insights from in vitro fertilization cycles. J Clin Endocrinol Metab. 2014 Nov;99(11):E2372-6. doi: 10.1210/jc.2014-1802. Epub 2014 Aug 14.
PubMed 25121462Polyzos NP, Anckaert E, Guzman L, Schiettecatte J, Van Landuyt L, Camus M, Smitz J, Tournaye H. Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Hum Reprod. 2014 Sep;29(9):2032-40. doi: 10.1093/humrep/deu156. Epub 2014 Jun 20.
PubMed 24951484Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fertil Steril. 2014 Dec;102(6):1608-12. doi: 10.1016/j.fertnstert.2014.08.030. Epub 2014 Sep 23.
PubMed 25256926
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Vitamin D Level in Subfertile Women and Its Association With Ovarian Reserve and IVF Outcome.
- ClinicalTrials.gov ID
- NCT02317718
- Acronym / sponsor ID
- VitD Study
- Conditions
- VITAMIN D Disorders
- Keywords
- serum vitamin D levels, IVF, ovarian reserve, 25 OHD3, pregnancy outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fakih IVF Fertility CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 16 Dec 2014 (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.
Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .
The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .
Detailed description
Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .
The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal vitamin D levels group | – | Other: monitor reproductive outcomeMORE THAN 20 NG/ML VITAMIN D LEVELS |
| Deficient Vitamin D GROUP | – | Other: monitor reproductive outcomeLESS THAN 20 NG/ML LEVELS |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing IVF between 20-42 years of age
Key inclusion criteria (3 listed)
- Subfertile women,
- Indication for IVF,
- 20-42 yrs of age.
Key exclusion criteria (2 listed)
- Women on therapeutic supplementation for Vitamin D Deficiency,
- Recurrent high order implantation failure
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 |
|---|---|---|
| monitor reproductive outcome | Other | Deficient Vitamin D GROUP, Normal vitamin D levels group |
Primary outcome
Clinical pregnancy rate
Time frame: 14 days post oocyte retrieval
3 secondary outcomes
AMH (antimullerian hormone) Levels
Time frame: day 2-3 of the index cycle
AFC (antral follicle count)
Time frame: DAY 2-3 OF INDEX CYCLE
Number of oocytes retreived
Time frame: Two weeks from the last menstrual period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Background: PubMed 25121462Paffoni A, Ferrari S, Vigano P, Pagliardini L, Papaleo E, Candiani M, Tirelli A, Fedele L, Somigliana E. Vitamin D deficiency and infertility: insights from in vitro fertilization cycles. J Clin Endocrinol Metab. 2014 Nov;99(11):E2372-6. doi: 10.1210/jc.2014-1802. Epub 2014 Aug 14.
- Background: PubMed 24951484Polyzos NP, Anckaert E, Guzman L, Schiettecatte J, Van Landuyt L, Camus M, Smitz J, Tournaye H. Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Hum Reprod. 2014 Sep;29(9):2032-40. doi: 10.1093/humrep/deu156. Epub 2014 Jun 20.
- Results publication: PubMed 25256926Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fertil Steril. 2014 Dec;102(6):1608-12. doi: 10.1016/j.fertnstert.2014.08.030. Epub 2014 Sep 23.
- Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Fertil Steril. 2014 Dec;102(6):1608-12.Link provided by the sponsor.
- Vitamin D Deficiency and Infertility: Insights From in vitro Fertilization Cycles. Paffoni A, Ferrari S, Viganò P, Pagliardini L, Papaleo E, Candiani M, Tirelli A, Fedele L, Somigliana E. J Clin Endocrinol Metab. 2014 NLink provided by the sponsor.
- Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Polyzos NP1, Anckaert E2, Guzman L3,Link provided by the sponsor.
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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.
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 VITAMIN D Disorders, run by Fakih IVF Fertility Center at 1 site in United Arab Emirates.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2014. 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 United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 14 days post oocyte retrieval). 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 NCT02317718, which also lists 3 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 16 Dec 2014.