NCT02361710

Brief Summary

The aim of this study is determining the affects of serum vitamin D levels to implantation and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer. Two groups will be identified according to the serum vitamin D levels on eFET transfer day and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared between those groups

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

February 8, 2015

Last Update Submit

January 27, 2016

Conditions

Keywords

Vitamin Dpregnancy rateeFET

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    The presence of intrauterine gestational sac at 7 weeks of gestation

    4 weeks after embryo transfer

Secondary Outcomes (2)

  • implantation rates

    3 weeks after embryo transfer

  • ongoing pregnancy rates

    18 weeks after embryo transfer

Study Arms (2)

vitamin D deficient patients

Serum 25- (hydroxide) OH Vitamin D levels \<20ng/L undergoing Frozen embryo transfer (Vitamin D levels are measured on the day of embryo transfer)

Procedure: frozen embryo transfer

vitamin D sufficient patients

Serum 25- (hydroxide) OH Vitamin D levels \>20ng/L undergoing Frozen embryo transfer (Vitamin D levels are measured on the day of embryo transfer)

Procedure: frozen embryo transfer

Interventions

comparison of groups according to their serum vitamin D levels on frozen embryo transfer day

vitamin D deficient patientsvitamin D sufficient patients

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Infertile women undergoing a frozen ET with 1 Day 5 (blastocyst stage) embryo

You may qualify if:

  • years to 35 years age, a frozen ET with 1 Day 5 (blastocyst stage) embryo
  • Infertile women undergoing ICSI (intracytoplasmic sperm injection) cycle
  • Factors affecting fertility are Tubal
  • Unexplained or ovulatory disturbances,

You may not qualify if:

  • Need to do Preimplantation Genetic Diagnosis
  • Presence of endometriosis and adenomyosis
  • Severe male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceci Fulya IVF Center

Istanbul, Fulya, 34800, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.

    PMID: 22914766BACKGROUND

Study Officials

  • mustafa bahceci

    bahceci Fulya IVF center

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2015

First Posted

February 12, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations