Clinical trial NCT02317718: Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome
Official title: Serum Vitamin D Level in Subfertile Women and Its Association With Ovarian Reserve and IVF Outcome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: VITAMIN D Disorders
Keywords: serum vitamin D levels
IVF
ovarian reserve
25 OHD3
pregnancy outcome
Lead sponsor: Fakih IVF Fertility Center
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IVF between 20-42 years of age

Brief 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. 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 14 days post oocyte retrieval
Secondary outcomes:
measure: AMH (antimullerian hormone) Levels
timeFrame: day 2-3 of the index cycle
measure: AFC (antral follicle count)
timeFrame: DAY 2-3 OF INDEX CYCLE
measure: Number of oocytes retreived
timeFrame: Two weeks from the last menstrual period
Other outcomes:
Locations:
city: Abudhabi
country: United Arab Emirates
facility: Fakihivf Fertiity Center
state: Abu Dhabi
Study officials:
References:
citation: 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.
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.
citation: 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.