The Genetic Role of Vitamin D Supplementation on Assisted Reproductive Technologies

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05091203
• Collaborator: (none)
• Enrollment: 75
• Arms: 2
• Anticipated Duration (Months): 3.9

Study Details

Study Description

Brief Summary

Studying the genetic 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.

Condition or Disease	Intervention/Treatment	Phase
Role of Vitamin D in IVF for Better Outcome	Drug: Vitamin D	N/A

Detailed Description

1. NintyNinety 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 from day 20 of the preceding cycle till the day of HCG administration for preparation of ICSI.

2. 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.

3. HCG and Vitamin D will be given when one or more of the growing follicles reaching 17 mm of diameter or more.

4. 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.

5. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Genetic Role of Vitamin D Supplementation on Assisted Reproductive Technologies
• Anticipated Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Mar 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Determine the level of Vitamin D in serum and follicular fluid in ng/ml [Stimulated Cycle a bout one month]

   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

2. Determine the level of BMP-15 in follicular fluid [Stimulated Cycle within one month]

   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

Secondary Outcome Measures

1. To find if there is a correlation between serum and follicular fluid level of Vitamin D in the same patient. [Stimulated Cycle within one month]

   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

2. 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 [Stimulated Cycle within one month]

   Determin the relation between vitamin D supplementation and other hormones

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age is between 20-40 years old.

2. Non PCOS patient.

3. With no previous or current evidence of OHSS (number of oocyte between 5-15 oocytes)

4. Normal Prolactin level.

5. No other endocrinological abnormality including thyroid disorder or diabetes.

6. Within normal ovarian reserve AMH(1-3) ng/ml No evidence of endometriosis.

7. 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:

1. Women older than 35 years of age or younger than 20 years old

2. Women with polycystic ovary syndrome PCOS (as defined according to the Rotterdam criteria)

3. Women who were diagnosed to have endometriosis within the last 1 year.

4. Women with ovarian hyper stimulation syndrome (OHSS).

5. Sever male factor infertility with immotile sperm which may affect embryo development

6. poor responder patient .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radwa Adel Hanafy, Principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05091203
• Other Study ID Numbers: Vitamin D and IVF
• First Posted: Oct 25, 2021
• Last Update Posted: Oct 25, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Radwa Adel Hanafy, Principle investigator, Assiut University: ICSI- Vitamin D- BMP-15 protein
• Additional relevant MeSH terms: Vitamin D

Study Results

No Results Posted as of Oct 25, 2021