Role of Vitamin D in IVF for Better OutcomeNCT05091203
Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
A study testing Vitamin D in people with Role of Vitamin D in IVF for Better Outcome, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Role of Vitamin D in IVF for Better Outcome
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- 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.
- Being tested
- Vitamin D
- Keywords
- ICSI- Vitamin D- BMP-15 protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
To investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | Control group in which vitamin D was not administrated. Receives: Drug: Vitamin D |
| Study group | Active comparator | Study group in which Vitamin D was administered Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Stimulated Cycle within one month
Secondary outcomes (2)
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
Measured: 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
Measured: Stimulated Cycle within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Nov 2022
- Primary completion31 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Vitamin D in IVF for Better OutcomeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Adel Hanafy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091203
- Sponsor's protocol ID
- Vitamin D and IVF
- Status last verified
- Jan 2024
- First submitted
- 2 Oct 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D as a Prognostic Marker on Assisted Reproductive Technologies Outcomes.
- ClinicalTrials.gov ID
- NCT05091203
- Acronym / sponsor ID
- Vitamin D and IVF
- Keywords
- ICSI- Vitamin D- BMP-15 protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Drug: Vitamin DControl group in which vitamin D was not administrated. |
| Study group | Active comparator | Drug: Vitamin DStudy group in which Vitamin D was administered |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DTo investigate role of vitamin D in follicular maturation and number of mature follicles which help in the success of IVF procedure | Drug | Study group, control |
Primary outcome
Determine the level of Vitamin D in serum and follicular fluid in ng/ml
Time frame: 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
Determine the level of BMP-15 in follicular fluid
Time frame: 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
2 secondary outcomes
To find if there is a correlation between serum and follicular fluid level of Vitamin D in the same patient.
Time frame: 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
Time frame: Stimulated Cycle within one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Role of Vitamin D in IVF for Better Outcome, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the level of Vitamin D in serum and follicular fluid in ng/ml (time frame: Stimulated Cycle a bout one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.