Ongoing Pregnancy RateNCT02361827
The Effect of Vitamin D on in Vitro Fertilization Outcome
An observational study of Ongoing Pregnancy Rate and Vitamin D, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Ongoing Pregnancy Rate, Vitamin D, in Vitro Fertilization
- What is being tested?
- Embryo transfer
- Type of treatment
- Surgery or procedure
- How many people
- 688 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2024
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients whose IVF cycles were cancelled due to ovarian hyperstimulation syndrome were also excluded);.
Who may be able to join
- age between 21-40 years old
- basal FSH hormone level less than 10 mIU/mL
- the first cycle of IVF treatment with standard long protocol
- both ovarian present and normal uterus.
Who cannot join
- Important data missing
- Gametes donation cycles
- Anyone that does not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: The Effect of Vitamin D on in Vitro Fertilization Outcome, a Prospective Observational Study
To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Thus, here the investigators carry this prospective observational cohort study to demonstrate the relationship between vitamin D level and IVF outcome.
Read the detailed description
Vitamin D level is measured before the commence of IVF cycle. According to Vitamin D level, patients are divided into 3 groups: A, Deficient, <20 ng/mL; B, Insufficient, 20-29.9 ng/mL; C, Replete, >30 ng/mL.
Ongoing pregnancy rate are compared among these three groups after controlling age, number of embryos transferred, ect.
In addition, Vitamin D level is also meassured before embryo transfer in FET cycles with PGT treatment. The effect of Vitamin D on IVF outcome is detected in patients transferred with Euploid embryos.
- Conditions
- Ongoing Pregnancy Rate, Vitamin D, in Vitro Fertilization
- Being tested
- Embryo transfer
- Keywords
- Vitamin D, IVF outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transferProcedure or surgery
For patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst.
| Study group | Role | What they receive |
|---|---|---|
| A1, Vitamin D deficient | Vitamin D level before cycle < 20 ng/mL. Receives: Procedure: Embryo transfer | |
| B1, Vitamin D insufficient | Vitamin D level before cycle 20-29.9 ng/mL Receives: Procedure: Embryo transfer | |
| C1, Vitamin D replete | Vitamin D level before cycle > 30 ng/mL Receives: Procedure: Embryo transfer | |
| A2, Vitamin D deficient | Vitamin D level before ET < 20 ng/mL (FET with Euploid embryos) Receives: Procedure: Embryo transfer | |
| B2, Vitamin D insufficient | Vitamin D level before ET 20-29.9 ng/mL (FET with Euploid embryos) Receives: Procedure: Embryo transfer | |
| C2, Vitamin D replete | Vitamin D level before ET > 30 ng/mL (FET with Euploid embryos) Receives: Procedure: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
Measured: 12 weeks after embryo transfer
Secondary outcomes (1)
Ectopic pregnancy rate
Ectopic pregnancy is defined as serum HCG positive, yet with no gestational sac present inside uterine cavity
Measured: 35 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study start1 Jan 2018
- Primary completion1 Sep 2022
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ongoing Pregnancy RateStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Luoyang maternal and child hospital
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Zhiqin Bu, MD, PhD, Principal investigator, Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361827
- Sponsor's protocol ID
- RMCZZU-Vitamin D
- Status last verified
- May 2026
- First submitted
- 8 Feb 2015
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Franasiak JM, Molinaro TA, Dubell EK, Scott KL, Ruiz AR, Forman EJ, Werner MD, Hong KH, Scott RT Jr. Vitamin D levels do not affect IVF outcomes following the transfer of euploid blastocysts. Am J Obstet Gynecol. 2015 Mar;212(3):315.e1-6. doi: 10.1016/j.ajog.2014.09.029. Epub 2014 Oct 11.
PubMed 25265402Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fertil Steril. 2014 Dec;102(6):1608-12. doi: 10.1016/j.fertnstert.2014.08.030. Epub 2014 Sep 23.
PubMed 25256926Paffoni A, Ferrari S, Vigano P, Pagliardini L, Papaleo E, Candiani M, Tirelli A, Fedele L, Somigliana E. Vitamin D deficiency and infertility: insights from in vitro fertilization cycles. J Clin Endocrinol Metab. 2014 Nov;99(11):E2372-6. doi: 10.1210/jc.2014-1802. Epub 2014 Aug 14.
PubMed 25121462Rudick BJ, Ingles SA, Chung K, Stanczyk FZ, Paulson RJ, Bendikson KA. Influence of vitamin D levels on in vitro fertilization outcomes in donor-recipient cycles. Fertil Steril. 2014 Feb;101(2):447-52. doi: 10.1016/j.fertnstert.2013.10.008. Epub 2013 Nov 5.
PubMed 24210230Wang K, Dong F, Ma S, Bu Z. The association between Vitamin D deficiency and clinical pregnancy rate in IVF patients with different age. Front Endocrinol (Lausanne). 2025 Jan 3;15:1485238. doi: 10.3389/fendo.2024.1485238. eCollection 2024.
PubMed 39829955
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D on in Vitro Fertilization Outcome, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02361827
- Acronym / sponsor ID
- RMCZZU-Vitamin D
- Conditions
- Ongoing Pregnancy Rate, Vitamin D, in Vitro Fertilization
- Keywords
- Vitamin D, IVF outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 688 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Luoyang maternal and child hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Feb 2015 (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.
To date, several studies have been done to explore the relationship between Vitamin D level and IVF outcome; however, the results are controversial. Sample sizes in these studies mentioned above were relatively small. In addition, there are no prospective cohort studies in this field. Thus, here the investigators carry this prospective observational cohort study to demonstrate the relationship between vitamin D level and IVF outcome.
Detailed description
Vitamin D level is measured before the commence of IVF cycle. According to Vitamin D level, patients are divided into 3 groups: A, Deficient, <20 ng/mL; B, Insufficient, 20-29.9 ng/mL; C, Replete, >30 ng/mL.
Ongoing pregnancy rate are compared among these three groups after controlling age, number of embryos transferred, ect.
In addition, Vitamin D level is also meassured before embryo transfer in FET cycles with PGT treatment. The effect of Vitamin D on IVF outcome is detected in patients transferred with Euploid embryos.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1, Vitamin D deficient | – | Procedure: Embryo transferVitamin D level before cycle < 20 ng/mL. |
| B1, Vitamin D insufficient | – | Procedure: Embryo transferVitamin D level before cycle 20-29.9 ng/mL |
| C1, Vitamin D replete | – | Procedure: Embryo transferVitamin D level before cycle > 30 ng/mL |
| A2, Vitamin D deficient | – | Procedure: Embryo transferVitamin D level before ET < 20 ng/mL (FET with Euploid embryos) |
| B2, Vitamin D insufficient | – | Procedure: Embryo transferVitamin D level before ET 20-29.9 ng/mL (FET with Euploid embryos) |
| C2, Vitamin D replete | – | Procedure: Embryo transferVitamin D level before ET > 30 ng/mL (FET with Euploid embryos) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients whose IVF cycles were cancelled due to ovarian hyperstimulation syndrome were also excluded);.
Key inclusion criteria (4 listed)
- age between 21-40 years old
- basal FSH hormone level less than 10 mIU/mL
- the first cycle of IVF treatment with standard long protocol
- both ovarian present and normal uterus.
Key exclusion criteria (3 listed)
- Important data missing
- Gametes donation cycles
- Anyone that does not meet the inclusion criteria
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 |
|---|---|---|
| Embryo transferFor patients in each group after oocyte retrieval, they will have embryo transferred 3 or 5 days after oocyte retrieval. For FET cycles, they will have ET with an euploid blastocyst. | Procedure or surgery | A1, Vitamin D deficient, A2, Vitamin D deficient, B1, Vitamin D insufficient, B2, Vitamin D insufficient, C1, Vitamin D replete, C2, Vitamin D replete |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer
12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
1 secondary outcome
Ectopic pregnancy rate
Time frame: 35 days after embryo transfer
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 27 May 2026.
- Background: PubMed 25265402Franasiak JM, Molinaro TA, Dubell EK, Scott KL, Ruiz AR, Forman EJ, Werner MD, Hong KH, Scott RT Jr. Vitamin D levels do not affect IVF outcomes following the transfer of euploid blastocysts. Am J Obstet Gynecol. 2015 Mar;212(3):315.e1-6. doi: 10.1016/j.ajog.2014.09.029. Epub 2014 Oct 11.
- Background: PubMed 25256926Fabris A, Pacheco A, Cruz M, Puente JM, Fatemi H, Garcia-Velasco JA. Impact of circulating levels of total and bioavailable serum vitamin D on pregnancy rate in egg donation recipients. Fertil Steril. 2014 Dec;102(6):1608-12. doi: 10.1016/j.fertnstert.2014.08.030. Epub 2014 Sep 23.
- Background: PubMed 25121462Paffoni A, Ferrari S, Vigano P, Pagliardini L, Papaleo E, Candiani M, Tirelli A, Fedele L, Somigliana E. Vitamin D deficiency and infertility: insights from in vitro fertilization cycles. J Clin Endocrinol Metab. 2014 Nov;99(11):E2372-6. doi: 10.1210/jc.2014-1802. Epub 2014 Aug 14.
- Background: PubMed 24210230Rudick BJ, Ingles SA, Chung K, Stanczyk FZ, Paulson RJ, Bendikson KA. Influence of vitamin D levels on in vitro fertilization outcomes in donor-recipient cycles. Fertil Steril. 2014 Feb;101(2):447-52. doi: 10.1016/j.fertnstert.2013.10.008. Epub 2013 Nov 5.
- Results publication: PubMed 39829955Wang K, Dong F, Ma S, Bu Z. The association between Vitamin D deficiency and clinical pregnancy rate in IVF patients with different age. Front Endocrinol (Lausanne). 2025 Jan 3;15:1485238. doi: 10.3389/fendo.2024.1485238. eCollection 2024.
Related trials for Ongoing Pregnancy Rate
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Not yet recruiting
Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
Recruiting
Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient
Acute Kidney Injury, Continuous Renal Replacement Therapy
Recruiting
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.
Hyaluronan-EnRiched Medium, Randomized Controlled Trial
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.
Zhiqin Bu, MD, PhD principal investigator
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ongoing Pregnancy Rate and Vitamin D, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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 4 inclusion and 3 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 27 May 2026. 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 China. 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.
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?
Ongoing pregnancy rate (time frame: 12 weeks after embryo transfer). 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 NCT02361827, which also lists 5 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 27 May 2026.