Clinical trial NCT05091203: Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
Official title: Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Role of Vitamin D in IVF for Better Outcome
Keywords: ICSI- Vitamin D- BMP-15 protein
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Determine the level of Vitamin D in serum and follicular fluid in ng/ml
timeFrame: Stimulated Cycle a bout one month
measure: Determine the level of BMP-15 in follicular fluid
timeFrame: Stimulated Cycle within one month
Secondary outcomes:
measure: To find if there is a correlation between serum and follicular fluid level of Vitamin D in the same patient.
timeFrame: Stimulated Cycle within one month
measure: 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
timeFrame: Stimulated Cycle within one month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: