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

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Northwestern University

Status

Terminated

Conditions

Infertility
Vitamin D Deficiency

Study type

Observational

Funder types

Other

Identifiers

NCT01419743
Moy 2011 Vit D

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

Female

Ages

18 to 38 years old

Volunteers

No 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)

Trial design

102 participants in 6 patient groups

patients with Vit D level of < 20ng/mL: Group 1
Description:
randomized to receive 400 IU of vitamin D per day
patients with Vit D levels <20ng/mL: Group 2
Description:
Randomized to receive 2000IU of Vitamin D per day
patients with vit D levels between 20-30 ng/mL: Group 3
Description:
Randomized to receiving placebo
patients with vit D levels between 20-30 ng/mL: Group 4
Description:
Randomized to receive 400IU of vitamin D per day
patients with vit D levels between 20-30 ng/mL: Group 5
Description:
Randomized to receive 2000IU of vitamin D per day
patients with vit D levels > 30ng/mL: Group 6
Description:
No treatment

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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