Vitamin D DeficiencyNCT03305510
Vitamin D Deficiency of Couples and Infertility
An observational study of Vitamin D Deficiency and Infertility, run by Tongji Hospital.
Trial summary
Between March 2016 and March 2017, we performed a large retrospective, non-interventional, single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and reproductive capacity . Read more about this study
- Who is it for?
- Ages 20 to 42 years
- Conditions the study is for
- Vitamin D Deficiency, Infertility, Couples
- What is being tested?
- vitamin D is below 20ng/ml
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 1 Jun 2017
- Phase
- Observational
- 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 42 years
- All sexes
- No healthy volunteers
- Adult
Study population: non-interventional, single-center cohort study and measured 25(OH) D plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.
Who may be able to join
- couples who underwent IVF/ICSI.
Who cannot join
- sperm or egg donation, PGD or PGS,TESA or PESA, ovum frozen ,no oocyte for fertilization.
About this study
Official title: Prospective Cohort Study About Vitamin D Deficiency of Couples and Infertility
Between March 2016 and March 2017, we performed a large retrospective, non-interventional, single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and reproductive capacity .
Read the detailed description
Before conducting ovarian stimulation, all couples must conduct preoperative routine examination such as routine blood test, blood group examination and infectious disease examination. We collected 2ml remaining blood from the examination by use of sodium heparin, which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry.
All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.
- Conditions
- Vitamin D Deficiency, Infertility, Couples, In-vitro Fertilization
- Being tested
- vitamin D is below 20ng/ml
- Medical subject headings
- Vitamin D Deficiency, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D is below 20ng/mlDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D deficiency | The level of vitamin D is below 20ng/ml. Receives: Diagnostic Test: vitamin D is below 20ng/ml | |
| Vitamin D insufficient | The level of vitamin D is between 20ng/ml and 30ng/ml. | |
| Vitamin D sufficient | The level of vitamin D is above 30ng/ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate
Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.
Measured: the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Jiang, Tongji Hospital
- Investigators
- Kun Qian, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305510
- Sponsor's protocol ID
- Reproductive center of Tongji
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jiang L, Yang J, Song J, Hu Y, Qian K. Normal fertilisation rates and serum 25-OHD levels among couples undergoing in-vitro fertilisation: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Jun 5;20(1):346. doi: 10.1186/s12884-020-02959-z.
PubMed 32503520
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study About Vitamin D Deficiency of Couples and Infertility
- ClinicalTrials.gov ID
- NCT03305510
- Acronym / sponsor ID
- Reproductive center of Tongji
- Conditions
- Vitamin D Deficiency, Infertility, Couples, In-vitro Fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 10 Oct 2017 (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.
Between March 2016 and March 2017, we performed a large retrospective, non-interventional, single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and reproductive capacity .
Detailed description
Before conducting ovarian stimulation, all couples must conduct preoperative routine examination such as routine blood test, blood group examination and infectious disease examination. We collected 2ml remaining blood from the examination by use of sodium heparin, which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry.
All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficiency | – | Diagnostic Test: vitamin D is below 20ng/mlThe level of vitamin D is below 20ng/ml. |
| Vitamin D insufficient | – | –The level of vitamin D is between 20ng/ml and 30ng/ml. |
| Vitamin D sufficient | – | –The level of vitamin D is above 30ng/ml. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- non-interventional, single-center cohort study and measured 25(OH) D plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.
Key inclusion criteria (1 listed)
- couples who underwent IVF/ICSI.
Key exclusion criteria (1 listed)
- sperm or egg donation, PGD or PGS,TESA or PESA, ovum frozen ,no oocyte for fertilization.
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 D is below 20ng/ml | Diagnostic test | Vitamin D deficiency |
Primary outcome
fertilization rate
Time frame: the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination
Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.
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 10 Oct 2017.
- Derived from this study: PubMed 32503520Jiang L, Yang J, Song J, Hu Y, Qian K. Normal fertilisation rates and serum 25-OHD levels among couples undergoing in-vitro fertilisation: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Jun 5;20(1):346. doi: 10.1186/s12884-020-02959-z.
- Individual participant dataSharing planned: Undecided
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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.
Kun Qian, Doctor study chair
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Infertility, run by Tongji Hospital.
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: finished, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
fertilization rate (time frame: the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination). 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 NCT03305510, which also lists 1 linked publication.
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 10 Oct 2017.