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

NCT ID: NCT02361710

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

frozen embryo transfer

Intervention Type PROCEDURE

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)

frozen embryo transfer

Intervention Type PROCEDURE

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

Interventions

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frozen embryo transfer

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bahceci Clinic

OTHER

Sponsor Role lead

Responsible Party

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C CELİK

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mustafa bahceci

Role: STUDY_DIRECTOR

bahceci Fulya IVF center

Locations

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Bahceci Fulya IVF Center

Istanbul, Fulya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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cem celik

Role: CONTACT

+905324205365

kubra n boynukalin

Role: CONTACT

+905336412040

Facility Contacts

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cem celik

Role: primary

+905324205365

kubra n boynukalin

Role: backup

+905336412040

References

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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.

Reference Type BACKGROUND
PMID: 22914766 (View on PubMed)

Other Identifiers

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BHC24120209

Identifier Type: -

Identifier Source: org_study_id

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