Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes

Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01419743

Enrollment

102

Registered

2011-08-18

Start date

2011-08-31

Completion date

2014-01-31

Last updated

2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Vitamin D Deficiency

Keywords

Vitamin D deficiency, Supplementation, Infertility, Clinical pregnancy rates

Brief summary

Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

Detailed description

The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

Inclusion criteria

* Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles

Exclusion criteria

* Infertile women aged \> 38 undergoing fresh invitro fertilization cycles * Patients undergoing frozen embryo transfers * Patients undergoing donor-egg cycles * Patients who have a contraindication to receiving Vitamin D (e.g. patients with history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or lymphoma)

Design outcomes

Primary

Measure	Time frame	Description
Clinical pregnancy rate	assessed at conclusion of the study (~ 1 yr)	Serum hCG will be drawn per routine IVF protocol (\ 10 days after embryo transfer). Patients will have a repeat bHCG drawn 48hrs if they have a positive result from the first bHCG test. Clinical pregnancy will be defined as ultrasound documentation of fetal heart tones.

Countries

United States

Outcome results