VITAMIN D Disorders Clinical Trial
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 .
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 42 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Arab Emirates | Fakihivf Fertiity Center | Abudhabi | Abu Dhabi |
| Lead Sponsor | Collaborator |
|---|---|
| Fakih IVF Fertility Center |
United Arab Emirates,
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.201 — View Citation
Paffoni A, Ferrari S, Viganò 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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical pregnancy rate | 14 days post oocyte retrieval | No | |
| Secondary | AMH (antimullerian hormone) Levels | day 2-3 of the index cycle | No | |
| Secondary | AFC (antral follicle count) | DAY 2-3 OF INDEX CYCLE | No | |
| Secondary | Number of oocytes retreived | Two weeks from the last menstrual period | No |