Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)

January 27, 2016 updated by: C CELİK, Bahceci Clinic

Comparing the Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the last decade there have been growing evidence about Vitamin D receptors and their role in female genital tract. But these studies are yet not well designed and the results should be interpreted cautiously. Although some of these studies advocating the Vitamin D deficiency as an negative circumstance on pregnancy rates some of the others don't agree. According to contradictory results understanding the actual role of those receptors needs more observation.

Latest retrospective analyse postulated that, vitamin D deficiency in fresh single embryo transfer cycles may reduce pregnancy rates mediated by endometrium or ovarian reserve and stimulation characteristics.

For this reason the investigators aimed to explore the effect of serum Vitamin D levels on pregnancy rates in infertile population undergoing frozen embryo transfer.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fulya
      • Istanbul, Fulya, Turkey, 34800
        • Recruiting
        • Bahceci Fulya IVF Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 18 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,

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
comparison of groups according to their serum vitamin D levels on frozen embryo transfer day
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
comparison of groups according to their serum vitamin D levels on frozen embryo transfer day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 4 weeks after embryo transfer
The presence of intrauterine gestational sac at 7 weeks of gestation
4 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rates
Time Frame: 3 weeks after embryo transfer
number of gestational sacs per transferred embryo.
3 weeks after embryo transfer
ongoing pregnancy rates
Time Frame: 18 weeks after embryo transfer
Pregnancy that had completed ≥20 weeks of gestation
18 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahceci Clinic

Investigators

  • Study Director: mustafa bahceci, Bahceci Fulya IVF Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

February 8, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (ESTIMATE)

February 12, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BHC24120209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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