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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02361710
• Other study ID #: BHC24120209
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2015
• Last updated: January 27, 2016
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: Bahceci Clinic
• Contact: cem celik
• Phone: +905324205365
• Email: cemcel[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Turkey	Bahceci Fulya IVF Center	Istanbul	Fulya

Sponsors (1)

Lead Sponsor	Collaborator
Bahceci Clinic

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	The presence of intrauterine gestational sac at 7 weeks of gestation	4 weeks after embryo transfer	No
Secondary	implantation rates	number of gestational sacs per transferred embryo.	3 weeks after embryo transfer	No
Secondary	ongoing pregnancy rates	Pregnancy that had completed =20 weeks of gestation	18 weeks after embryo transfer	No