InfertilityNCT02365337
Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters
An observational study of Infertility, run by Bahceci Clinic at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is observing the relation between serum Vitamin D levels and morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor infertility. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2015to Jul 2016
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: participants will be recruited among infertile women who is seeking for IVF treatment and fullfilling the inclusion criteria.
Who may be able to join
- 18 years to 38 years age, 2 or less in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) attempt history, Unexplained or tubal factor infertility, Serum Follicle Stimulating Hormone (FSH) < 10, Antral Follicule Count (AFC)> 6-8
Who cannot join
- Male factor infertility, Presence of endometriosis or adenomyosis,Diminished ovarian reserve
Trial locations and contacts
1 site in 1 country.
kubra n boynukalin contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahceci Fulya IVF Center
Istanbul, Fulya, 34800
cem celik, +905324205365, cemcel@yahoo.com
n, kboynukalin@gmail.com
About this study
Official title: Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters in Women Undergoing Controlled Ovarian Hyperstimulation
The aim of this study is observing the relation between serum Vitamin D levels and morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as normal or low , and the influence of those levels in morphokinetic parameters of embryos will be identified.
Read the detailed description
Up to date there are few studies questioning the serum Vitamin D deficiency as a negative factor for pregnancy rates in women undergoing COH cycles and also are displaying different and inconclusive results. This dedicated negative affects may be mediated through endometrial and/or ovarial factors. In experimental animal models Vitamin D receptors have been found in endometrium and ovaries and deficient levels might have been a cause of impaired folliculogenesis. In one of human study Vitamin D has been suggested as a positive regulator of anti- Mullerian hormone (AMH) production. Therefore, we aimed to clarify the affects of Vitamin D on folliculogenesis, oogenesis and embryo quality in COH cycles by using time lapse monitoring.
- Conditions
- Infertility
- Keywords
- Vitamin D, time lapse monitoring, embryo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D levels < 20ng/ ml | Vitamin D levels < 20ng/ ml | |
| vitamin D levels>20ng/ ml | Vitamin D levels >20ng/ ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to 2 pronucleus (PN) membrane breakdown, first cleavage and 3, 4, 5, 6, 7, and 8 cells stages, morula and blastocyst stage (t2, t3, t4, t5, t6, t7, t8, t Morula (M), t Blastocyst (B) )
Measured: between 17 and 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
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 InfertilityStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahceci Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C CELİK, Bahceci Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365337
- Sponsor's protocol ID
- BHC19771981
- Status last verified
- Jan 2016
- First submitted
- 9 Feb 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16.
PubMed 22508713
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters in Women Undergoing Controlled Ovarian Hyperstimulation
- ClinicalTrials.gov ID
- NCT02365337
- Acronym / sponsor ID
- BHC19771981
- Conditions
- Infertility
- Keywords
- Vitamin D, time lapse monitoring, embryo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bahceci ClinicUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 18 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.
The aim of this study is observing the relation between serum Vitamin D levels and morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as normal or low , and the influence of those levels in morphokinetic parameters of embryos will be identified.
Detailed description
Up to date there are few studies questioning the serum Vitamin D deficiency as a negative factor for pregnancy rates in women undergoing COH cycles and also are displaying different and inconclusive results. This dedicated negative affects may be mediated through endometrial and/or ovarial factors. In experimental animal models Vitamin D receptors have been found in endometrium and ovaries and deficient levels might have been a cause of impaired folliculogenesis. In one of human study Vitamin D has been suggested as a positive regulator of anti- Mullerian hormone (AMH) production. Therefore, we aimed to clarify the affects of Vitamin D on folliculogenesis, oogenesis and embryo quality in COH cycles by using time lapse monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D levels < 20ng/ ml | – | –Vitamin D levels < 20ng/ ml |
| vitamin D levels>20ng/ ml | – | –Vitamin D levels >20ng/ ml |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- participants will be recruited among infertile women who is seeking for IVF treatment and fullfilling the inclusion criteria.
Key inclusion criteria (1 listed)
- 18 years to 38 years age, 2 or less in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) attempt history, Unexplained or tubal factor infertility, Serum Follicle Stimulating Hormone (FSH) < 10, Antral Follicule Count (AFC)> 6-8
Key exclusion criteria (1 listed)
- Male factor infertility, Presence of endometriosis or adenomyosis,Diminished ovarian reserve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
time to 2 pronucleus (PN) membrane breakdown, first cleavage and 3, 4, 5, 6, 7, and 8 cells stages, morula and blastocyst stage (t2, t3, t4, t5, t6, t7, t8, t Morula (M), t Blastocyst (B) )
Time frame: between 17 and 120 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Background: PubMed 22508713Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16.
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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.
kubra n boynukalin contact
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 Infertility, run by Bahceci Clinic 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 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 28 Jan 2016. 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.
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?
Contact cem celik (+905324205365, cemcel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to 2 pronucleus (PN) membrane breakdown, first cleavage and 3, 4, 5, 6, 7, and 8 cells stages, morula and blastocyst stage (t2, t3, t4, t5, t6, t7, t8, t Morula (M), t Blastocyst (B) ) (time frame: between 17 and 120 hours). 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 NCT02365337, 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 28 Jan 2016.