InfertilityPhase 4NCT03890458
The Effect of Vitamin D on Fertility
A Phase 4 study testing DEVIT-3 in people with Infertility and Infertility, Female, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles. Design: Experimental study with a pre- and post-test. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Infertility, Female, Vitamin D Deficiency
- What is being tested?
- DEVIT-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 30 Nov 2017
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old
- literate in Turkish
- voluntary participation
- primarily infertile
- had undergone controlled ovarian hyperstimulation and had a fresh ET
- vitamin D levels lower than 30ng/mL before infertility treatment
Who cannot join
- patients with uncorrected congenital or acquired uterine anomalies
- bone, parathyroid gland, kidney and liver disorders
- use of anticonvulsants/antacid drugs
- taking dietary supplements contain vitamin D
- secondary infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles
Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles.
Design: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the control group.
Read more
Intervention(s): At the beginning of the infertility treatment, the experimental group took vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile women includes regulation of a diet rich in vitamin D, educational and motivational interviews about insolation, and taking vitamin D orally.
Main Outcome Measure(s): 25(OH)D and beta HCG levels
- Being tested
- DEVIT-3
- Keywords
- vitamin D, vitamin D supplementation, infertility, D vitamin deficiency, infertile women, embryo transfer, pregnancy rate
- Medical subject headings
- Infertility, Infertility, Female, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEVIT-3Drug
The physicians gave the women in the experimental group vitamin D oral drops in an ampoule of 300,000 IU and a vial of 50,000 IU to take during the IVF treatment. Written and verbal information about how to take vitamin D was provided to the participants by the nurses. The women took 300,000 IU vitamin D orally for the first week. In the second week of the treatment, 50,000 IU vitamin D (15 drops/day) was used as maintenance dose until the pregnancy test day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: DEVIT-3 |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Vitamin D level
The vitamin D blood test was measured by the level of 25(OH)D.
Measured: The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest)
Blood Vitamin D level
The vitamin D blood test was measured by the level of 25(OH)D.
Measured: The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest)
Secondary outcomes (1)
Biochemical pregnancy
The pregnancy test was measured level of HCG in the blood.
Measured: HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Akdeniz 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gamze Teskereci, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890458
- Sponsor's protocol ID
- 02
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplements on Pregnancy Outcomes in Embriyo Transfer Cycles
- ClinicalTrials.gov ID
- NCT03890458
- Acronym / sponsor ID
- 02
- Keywords
- vitamin D, vitamin D supplementation, infertility, D vitamin deficiency, infertile women, embryo transfer, pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 26 Mar 2019 (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.
Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical pregnancy rate in embryo transfer cycles.
Design: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the control group.
Intervention(s): At the beginning of the infertility treatment, the experimental group took vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile women includes regulation of a diet rich in vitamin D, educational and motivational interviews about insolation, and taking vitamin D orally.
Main Outcome Measure(s): 25(OH)D and beta HCG levels
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DEVIT-3 |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-45 years old
- literate in Turkish
- voluntary participation
- primarily infertile
- had undergone controlled ovarian hyperstimulation and had a fresh ET
Key exclusion criteria (5 listed)
- patients with uncorrected congenital or acquired uterine anomalies
- bone, parathyroid gland, kidney and liver disorders
- use of anticonvulsants/antacid drugs
- taking dietary supplements contain vitamin D
- secondary infertility
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 |
|---|---|---|
| DEVIT-3The physicians gave the women in the experimental group vitamin D oral drops in an ampoule of 300,000 IU and a vial of 50,000 IU to take during the IVF treatment. Written and verbal information about how to take vitamin D was provided to the participants by the nurses. The women took 300,000 IU vitamin D orally for the first week. In the second week of the treatment, 50,000 IU vitamin D (15 drops/day) was used as maintenance dose until the pregnancy test day. | Drug | Experimental |
Primary outcome
Blood Vitamin D level
Time frame: The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest)
The vitamin D blood test was measured by the level of 25(OH)D.
Blood Vitamin D level
Time frame: The 25 (OH)D levels of the women were tested on the two weeks after embryo transfer. (Posttest)
The vitamin D blood test was measured by the level of 25(OH)D.
1 secondary outcome
Biochemical pregnancy
Time frame: HCG levels of the women were evaluated on the two weeks after embryo transfer (Post test)
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 26 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Gamze Teskereci principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEVIT-3 in people with Infertility and Infertility, Female, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 26 Mar 2019. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood Vitamin D level (time frame: The 25 (OH)D levels of the experimental group women were tested on the second or third day of their menstrual cycle. (Pretest)). 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 26 Mar 2019.