Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.

Study Overview
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Brief Summary
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Studying the effect of Vitamin D administration on assisted reproductive outcomes in women undergoing Intra Cytoplasmic Sperm Injection (ICSI) by giving a dose of vitamin D and determining the effect of this dose on both the quality embryos, implantation and ongoing pregnancy rate.

Detailed Description
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Ninty women will include in the study. All patients will be treated with gonadotropin releasing hormone (GnRH) agonist Decapeptyl 0.1 mg subcutenoussubcutaneous FeringFerring, Germany and vitamin D (D- Dep) from day 20 of the preceding cycle till the day of HCG administration for preparation of ICSI. Controlled ovarian hyper stimulation will be done with Gonal F recombinant FSH, starting from day 3 of the stimulation cycle according to the standard protocol of the center. The dose is calculated according to the ovarian reserve, age as the BMI. HCG and Vitamin D will be given when one or more of the growing follicles reaching 17 mm of diameter or more. Ovum pickup was done guided by the transvaginal ultrasonography 34-36 hours after HCG administration. Follicular fluid and blood sample were obtained at the time of ovum pickup for ICSI/IVF. This prospective randomized case control trial will include 90 women who will be allocated IVF/ICSI. They will be sub divided into a study and a control group; each group will include 45 women.

Official Title
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Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.

Conditions
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Role of Vitamin D in IVF for Better Outcome

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is between 20-40 years old. Non PCOS patient. With no previous or current evidence of OHSS (number of oocyte between 5-15 oocytes) Normal Prolactin level. No other endocrinological abnormality including thyroid disorder or diabetes. Within normal ovarian reserve AMH(1-3) ng/ml No evidence of endometriosis. No other medical or surgical diseases. 10-Careful history, general and local examination, abdominal and vaginal ultrasonography and basal haematological and chemical investigations were done to exclude any other abnormalities which can interfere with the result of the current study. Exclusion Criteria: Women older than 35 years of age or younger than 20 years old Women with polycystic ovary syndrome PCOS (as defined according to the Rotterdam criteria) Women who were diagnosed to have endometriosis within the last 1 year. Women with ovarian hyper stimulation syndrome (OHSS). Sever male factor infertility with immotile sperm which may affect embryo development poor responder patient .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control<br>Control group in which vitamin D was not administrated. | Drug: Vitamin D<br>* To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure<br>|
| Active Comparator: Study group<br>Study group in which Vitamin D was administered | Drug: Vitamin D<br>* To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the level of Vitamin D in serum and follicular fluid in ng/ml | Determine the level of Vitamin D in serum and follicular fluid in stimulated cycle for IVF/ICSI in normal responder women and comparison its level between study group (in which Vitamin D was administered) and control group ( in which vitamin D was not administrated) and its effect on oocyte quality by the use of ELISA test | Stimulated Cycle a bout one month | 
| Determine the level of BMP-15 in follicular fluid | 2- Determine the level of BMP-15 in follicular fluid in stimulated cycle for IVF/ICSI in normal responder women and comparison its level between study group(in which Vitamin D was administered) and control group ( in which vitamin D was not administrated) and its effect on oocyte quality by Western Plot test | Stimulated Cycle within one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find if there is a correlation between serum and follicular fluid level of Vitamin D in the same patient. | After supplementation of vitamin D we will specify if there is a relation between serum and follicular fluid level of vitamin D in the same patient | Stimulated Cycle within one month | 
| 4- To find if there is a relation between vitamin D and BMP 15 levels and other hormones like AMH, FSH, E2, TSH and prolactin | Determin the relation between vitamin D supplementation and other hormones | Stimulated Cycle within one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICSI- Vitamin D- BMP-15 protein