Pregnancy ComplicationPhase 3DeliveryNCT01019785
Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial
A Phase 3 study testing Ergocalciferol in people with Pregnancy Complication, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Complication
- What is being tested?
- Ergocalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2009to Nov 2011
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women initiating IVF treatment
Who cannot join
- Women that have entered the study before
Trial locations and contacts
1 site in 1 country.
About this study
During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation
- Conditions
- Pregnancy Complication
- Being tested
- Ergocalciferol
- Keywords
- Pregnancy rate (pos test, live fetus at 12 weeks, baby home), Pregnancy complication (Pregnancy hypertension, SGA, diab), Thrombin generation
- Medical subject headings
- Pregnancy Complications, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDietary supplement
Also called Made by the Swedish APOTEKET
100 000 U drops is given once
ErgocalciferolDietary supplement
500 U drops given once
| Study group | Role | What they receive |
|---|---|---|
| High dose Vitamin D | Active comparator | Not described Receives: Dietary Supplement: Ergocalciferol |
| Low dose Vitamin D | Sham comparator | Not described Receives: Dietary Supplement: Ergocalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate
Measured: 4 weeks to 9 month
Secondary outcomes (1)
Pregnancy complications (pregnancy hypertension, SGA, diabetes)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019785
- Sponsor's protocol ID
- Delivery2009
- Acronym
- Delivery
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Epstein E, Lindqvist PG, Geppert B, Olsson H. A population-based cohort study on sun habits and endometrial cancer. Br J Cancer. 2009 Aug 4;101(3):537-40. doi: 10.1038/sj.bjc.6605149. Epub 2009 Jun 23.
PubMed 19550419Lindqvist PG, Epstein E, Olsson H. Does an active sun exposure habit lower the risk of venous thrombotic events? A D-lightful hypothesis. J Thromb Haemost. 2009 Apr;7(4):605-10. doi: 10.1111/j.1538-7836.2009.03312.x.
PubMed 19335448Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.
PubMed 32851663
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01019785
- Acronym / sponsor ID
- Delivery / Delivery2009
- Conditions
- Pregnancy Complication
- Keywords
- Pregnancy rate (pos test, live fetus at 12 weeks, baby home), Pregnancy complication (Pregnancy hypertension, SGA, diab), Thrombin generation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (estimated)
- First posted
- 25 Nov 2009 (estimated)
- 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.
During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Vitamin D | Active comparator | Dietary Supplement: Ergocalciferol |
| Low dose Vitamin D | Sham comparator | Dietary Supplement: Ergocalciferol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women initiating IVF treatment
Key exclusion criteria (1 listed)
- Women that have entered the study before
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 |
|---|---|---|
| ErgocalciferolAlso: Made by the Swedish APOTEKET100 000 U drops is given once | Dietary supplement | High dose Vitamin D |
| Ergocalciferol500 U drops given once | Dietary supplement | Low dose Vitamin D |
Primary outcome
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate
Time frame: 4 weeks to 9 month
1 secondary outcome
Pregnancy complications (pregnancy hypertension, SGA, diabetes)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- Background: PubMed 19550419Epstein E, Lindqvist PG, Geppert B, Olsson H. A population-based cohort study on sun habits and endometrial cancer. Br J Cancer. 2009 Aug 4;101(3):537-40. doi: 10.1038/sj.bjc.6605149. Epub 2009 Jun 23.
- Background: PubMed 19335448Lindqvist PG, Epstein E, Olsson H. Does an active sun exposure habit lower the risk of venous thrombotic events? A D-lightful hypothesis. J Thromb Haemost. 2009 Apr;7(4):605-10. doi: 10.1111/j.1538-7836.2009.03312.x.
- Derived from this study: PubMed 32851663Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.
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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.
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 Phase 3 study testing Ergocalciferol in people with Pregnancy Complication, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Nov 2009. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate (time frame: 4 weeks to 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01019785, which also lists 3 linked publications.
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 25 Nov 2009.