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

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.

Study Overview

• Status: Completed
• Conditions: Role of Vitamin D in IVF for Better Outcome
• Intervention / Treatment: Drug: Vitamin D

Detailed Description

1. 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.
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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ICSI- Vitamin D- BMP-15 protein
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: Vitamin D and IVF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No