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

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ClinicalTrials.gov Identifier: NCT02361710
Recruitment Status : Unknown
Verified January 2016 by C CELİK, Bahceci Clinic.
Recruitment status was:  Recruiting
First Posted : February 12, 2015
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
C CELİK, Bahceci Clinic

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

Condition or disease Intervention/treatment
Pregnancy Procedure: frozen embryo transfer

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparing the Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)
Study Start Date : April 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 4 weeks after embryo transfer ]
    The presence of intrauterine gestational sac at 7 weeks of gestation


Secondary Outcome Measures :
  1. implantation rates [ Time Frame: 3 weeks after embryo transfer ]
    number of gestational sacs per transferred embryo.

  2. ongoing pregnancy rates [ Time Frame: 18 weeks after embryo transfer ]
    Pregnancy that had completed ≥20 weeks of gestation



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infertile women undergoing a frozen ET with 1 Day 5 (blastocyst stage) embryo
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361710


Contacts
Contact: cem celik +905324205365 cemcel@yahoo.com
Contact: kubra n boynukalin +905336412040 kboynukalin@gmail.com

Locations
Turkey
Bahceci Fulya IVF Center Recruiting
Istanbul, Fulya, Turkey, 34800
Contact: cem celik    +905324205365    cemcel@yahoo.com   
Contact: kubra n boynukalin    +905336412040    kboynukalin@gmail.com   
Sponsors and Collaborators
Bahceci Clinic
Investigators
Study Director: mustafa bahceci bahceci Fulya IVF center

Publications:
Responsible Party: C CELİK, Associate Professor, Bahceci Clinic
ClinicalTrials.gov Identifier: NCT02361710     History of Changes
Other Study ID Numbers: BHC24120209
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by C CELİK, Bahceci Clinic:
Vitamin D
pregnancy rate
eFET

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents