Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-01 @ 8:04 PM
Study NCT ID:
NCT05091203
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2021-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: