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

Study Overview
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Procedure: frozen embryo transfer


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vitamin D deficient patients<br>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<br>* comparison of groups according to their serum vitamin D levels on frozen embryo transfer day<br>|
| vitamin D sufficient patients<br>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<br>* comparison of groups according to their serum vitamin D levels on frozen embryo transfer day<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, pregnancy rate, eFET