Serum Vitamin D Level and Its Association With Ovarian Reserve and IVF Outcome

• Conditions: VITAMIN D Disorders
• Interventions: Other: monitor reproductive outcome

• Registration Number: NCT02317718
• Lead Sponsor: Fakih IVF Fertility Center

Brief Summary

Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .

The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Detailed Description

Vitamin D has a major play in bone and calcium metabolism. Vitamin D deficiency (below 20 ng/ml) has also been linked to adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. Recent data from retrospective and prospective trials have demonstrated contradictive results concerning the role of vitamin D in female reproduction and IVF outcome. Some studies have found that women deficient in vitamin D had lower ovarian reserve and significantly lower clinical pregnancy rates when compared to patients who were sufficient levels in vitamin D. Some studies also demonstrated that serum 25-OH-D3 levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age. It may also have a role to play in endocrine dysfunction and abnormal folliculogenesis in polycystic ovaries .

The aim of this prospective cohort study including infertile women undergoing IVF treatment is to investigate the association between serum 25-OH- D3 levels and parametres of ovarian reserve (AMH, antral follicle count, number of oocytes collected) and clinical pregnancy and miscarriage rates .

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-11
• Last Update Submitted: 2014-12-11
• Study First Posted: 2014-12-16
• Last Update Posted: 2014-12-16
• Primary Completion: 2015-06
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Subfertile women,
• Indication for IVF,
• 20-42 yrs of age.

Exclusion Criteria

• Women on therapeutic supplementation for Vitamin D Deficiency,
• Recurrent high order implantation failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal vitamin D levels group	monitor reproductive outcome	MORE THAN 20 NG/ML VITAMIN D LEVELS
Deficient Vitamin D GROUP	monitor reproductive outcome	LESS THAN 20 NG/ML LEVELS

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	14 days post oocyte retrieval

Secondary Outcome Measures

Name	Time	Method
Number of oocytes retreived	Two weeks from the last menstrual period
AMH (antimullerian hormone) Levels	day 2-3 of the index cycle
AFC (antral follicle count)	DAY 2-3 OF INDEX CYCLE

Trial Locations

Locations (1)

Fakihivf Fertiity Center; 🇦🇪 Abudhabi, Abu Dhabi, United Arab Emirates