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Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome

NCT ID: NCT02317718

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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VITAMIN D Disorders

Keywords

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serum vitamin D levels IVF ovarian reserve 25 OHD3 pregnancy outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal vitamin D levels group

MORE THAN 20 NG/ML VITAMIN D LEVELS

monitor reproductive outcome

Intervention Type OTHER

Deficient Vitamin D GROUP

LESS THAN 20 NG/ML LEVELS

monitor reproductive outcome

Intervention Type OTHER

Interventions

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monitor reproductive outcome

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subfertile women,
* Indication for IVF,
* 20-42 yrs of age.

Exclusion Criteria

* Women on therapeutic supplementation for Vitamin D Deficiency,
* Recurrent high order implantation failure
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fakih IVF Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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monika chawla

Specialist Reproductive Endocrinology and Infertility

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fakihivf Fertiity Center

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Facility Contacts

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MONIKA CHAWLA, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25121462 (View on PubMed)

Polyzos 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.

Reference Type BACKGROUND
PMID: 24951484 (View on PubMed)

Fabris 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.

Reference Type RESULT
PMID: 25256926 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/25265402

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.

http://www.ncbi.nlm.nih.gov/pubmed/25256926

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 N

http://www.ncbi.nlm.nih.gov/pubmed/24951484

Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Polyzos NP1, Anckaert E2, Guzman L3,

Other Identifiers

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VitD Study

Identifier Type: -

Identifier Source: org_study_id