Disorder of Phosphate, Calcium and Vitamin D MetabolismNCT02341365
Vitamin D Influence on Oocyte Donation
An observational study of Disorder of Phosphate, Calcium and Vitamin D Metabolism and Female Infertility Due to Diminished Ovarian Reserve, run by IVI Madrid.
Trial summary
Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin D, ovarian reserve and ovarian response to controlled stimulation in egg donors. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Disorder of Phosphate, Calcium and Vitamin D Metabolism, Female Infertility Due to Diminished Ovarian Reserve, Hormonal Requirement
- What is being tested?
- vitamin D,AMH, AFC, reproductive outcome egg recipients
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 2015
- 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 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Study population: oocytes' donors who underwent ovarian stimulation cycles in our clinic from June 2013 to April 2014
Who may be able to join
- Caucasian race,
- between 18 and 34 years of age,
- all donors had normal menstrual cycles of 26-34 days,
- normal weight range (BMI 18- 25 Kg/m2),
- normal uterus and ovaries on transvaginal ultrasound (no signs of polycystic ovarian syndrome), and
- an antral follicle count (AFC) >10,
- normal karyotype
Who cannot join
- current or past exposure to radiation or hazardous chemical substances,
- history of drug use,
- family history of hereditary chromosomal diseases,
- sexually transmitted diseases
About this study
Official title: Impact of Vitamin D Levels on Ovarian Reserve and Ovarian Response to Controlled Stimulation in Egg Donors
Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin D, ovarian reserve and ovarian response to controlled stimulation in egg donors.
Read the detailed description
Design: Retrospective study. Setting: University affiliated private IVF center. Intervention: Serum analysis of vitamin D, bioavailable vitamin D, antimullerian hormone (AMH), antral follicular count (AFC), reproductive outcome of oocytes recipients Main outcome measure: AMH, AFC, number of oocytes retrieved and number of mature oocytes, pregnancy and implantation rate of donated oocytes'recipients.
- Conditions
- Disorder of Phosphate, Calcium and Vitamin D Metabolism, Female Infertility Due to Diminished Ovarian Reserve, Hormonal Requirement, Reproductive Disorder
- Being tested
- vitamin D,AMH, AFC, reproductive outcome egg recipients
- Keywords
- Egg donation, vitaminD, ovarian reserve, ovarian stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D,AMH, AFC, reproductive outcome egg recipientsOther
observational study of 269 donnors
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of oocytes retrieved
Measured: 2 months
Secondary outcomes (5)
implantation rate
Measured: 2 months
pregnancy rate
Measured: 2 months
AFC
Measured: 2 months
number of mature oocytes
Measured: 2 months
AMH
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionJan 2015
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 Disorder of Phosphate, Calcium and Vitamin D MetabolismStudies of the same condition, open and under way.
- 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
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Antonio García Velasco, Professor, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341365
- Sponsor's protocol ID
- 1406-MAD-035-JG
- Status last verified
- Jan 2015
- First submitted
- 7 Nov 2014
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Holick MF et al. Endocrine Society. Evaluation, treatment, prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1911-1930 Rudick B et al. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012;27:3321-7 Polyzos NP et al. Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Hum Reprod. 2014;29:2032-40 Franasiak JM et al. Vitamin D levels do not affect IVF outcomes following the transfer of euploid blastocysts. Am J Obstet Gynecol 2014;211:x.ex-x.ex Fabris 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. Irani M, Merhi Z. Role of vitamin D in ovarian physiology and its implication in reproduction: a systematic review. Fertil Steril. 2014 ;102:460-468
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Levels on Ovarian Reserve and Ovarian Response to Controlled Stimulation in Egg Donors
- ClinicalTrials.gov ID
- NCT02341365
- Acronym / sponsor ID
- 1406-MAD-035-JG
- Conditions
- Disorder of Phosphate, Calcium and Vitamin D Metabolism, Female Infertility Due to Diminished Ovarian Reserve, Hormonal Requirement, Reproductive Disorder
- Keywords
- Egg donation, vitaminD, ovarian reserve, ovarian stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 Jan 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.
Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin D, ovarian reserve and ovarian response to controlled stimulation in egg donors.
Detailed description
Design: Retrospective study. Setting: University affiliated private IVF center. Intervention: Serum analysis of vitamin D, bioavailable vitamin D, antimullerian hormone (AMH), antral follicular count (AFC), reproductive outcome of oocytes recipients Main outcome measure: AMH, AFC, number of oocytes retrieved and number of mature oocytes, pregnancy and implantation rate of donated oocytes'recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- oocytes' donors who underwent ovarian stimulation cycles in our clinic from June 2013 to April 2014
Key inclusion criteria (7 listed)
- Caucasian race,
- between 18 and 34 years of age,
- all donors had normal menstrual cycles of 26-34 days,
- normal weight range (BMI 18- 25 Kg/m2),
- normal uterus and ovaries on transvaginal ultrasound (no signs of polycystic ovarian syndrome), and
Key exclusion criteria (4 listed)
- current or past exposure to radiation or hazardous chemical substances,
- history of drug use,
- family history of hereditary chromosomal diseases,
- sexually transmitted diseases
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,AMH, AFC, reproductive outcome egg recipientsobservational study of 269 donnors | Other | – |
Primary outcome
Numbers of oocytes retrieved
Time frame: 2 months
5 secondary outcomes
implantation rate
Time frame: 2 months
pregnancy rate
Time frame: 2 months
AFC
Time frame: 2 months
number of mature oocytes
Time frame: 2 months
AMH
Time frame: 2 months
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 19 Jan 2015.
- Results publicationHolick MF et al. Endocrine Society. Evaluation, treatment, prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1911-1930 Rudick B et al. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012;27:3321-7 Polyzos NP et al. Vitamin D deficiency and pregnancy rates in women undergoing single embryo, blastocyst stage, transfer (SET) for IVF/ICSI. Hum Reprod. 2014;29:2032-40 Franasiak JM et al. Vitamin D levels do not affect IVF outcomes following the transfer of euploid blastocysts. Am J Obstet Gynecol 2014;211:x.ex-x.ex Fabris 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. Irani M, Merhi Z. Role of vitamin D in ovarian physiology and its implication in reproduction: a systematic review. Fertil Steril. 2014 ;102:460-468
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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.
Juan Antonio García Velasco, Professor principal investigator
IVI Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Phosphate, Calcium and Vitamin D Metabolism and Female Infertility Due to Diminished Ovarian Reserve, run by IVI Madrid.
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 7 inclusion and 4 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 19 Jan 2015. 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?
Numbers of oocytes retrieved (time frame: 2 months). 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 NCT02341365, 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 19 Jan 2015.