PregnancyNCT02361710
Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)
An observational study of Pregnancy, run by Bahceci Clinic at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is determining the affects of serum vitamin D levels to implantation and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- frozen embryo transfer
- Type of treatment
- Surgery or procedure
- How many people
- 200 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women undergoing a frozen ET with 1 Day 5 (blastocyst stage) embryo
Who may be able to join
- 18 years to 35 years age, a frozen ET with 1 Day 5 (blastocyst stage) embryo
- Infertile women undergoing ICSI (intracytoplasmic sperm injection) cycle
- Factors affecting fertility are Tubal
- Unexplained or ovulatory disturbances,
Who cannot join
- Need to do Preimplantation Genetic Diagnosis
- Presence of endometriosis and adenomyosis
- Severe male factor infertility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahceci Fulya IVF Center
Istanbul, Fulya, 34800
cem celik, +905324205365, cemcel@yahoo.com
kubra n boynukalin, +905336412040, kboynukalin@gmail.com
About this study
Official title: Comparing the Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)
The aim of this study is determining the affects of serum vitamin D levels to implantation and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer. Two groups will be identified according to the serum vitamin D levels on eFET transfer day and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared between those groups
Read the detailed description
In the last decade there have been growing evidence about Vitamin D receptors and their role in female genital tract. But these studies are yet not well designed and the results should be interpreted cautiously. Although some of these studies advocating the Vitamin D deficiency as an negative circumstance on pregnancy rates some of the others don't agree. According to contradictory results understanding the actual role of those receptors needs more observation.
Latest retrospective analyse postulated that, vitamin D deficiency in fresh single embryo transfer cycles may reduce pregnancy rates mediated by endometrium or ovarian reserve and stimulation characteristics.
For this reason the investigators aimed to explore the effect of serum Vitamin D levels on pregnancy rates in infertile population undergoing frozen embryo transfer.
- Conditions
- Pregnancy
- Being tested
- frozen embryo transfer
- Keywords
- Vitamin D, pregnancy rate, eFET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frozen embryo transferProcedure or surgery
comparison of groups according to their serum vitamin D levels on frozen embryo transfer day
| Study group | Role | What they receive |
|---|---|---|
| vitamin D deficient patients | Serum 25- (hydroxide) OH Vitamin D levels <20ng/L undergoing Frozen embryo transfer (Vitamin D levels are measured on the day of embryo transfer) Receives: Procedure: frozen embryo transfer | |
| vitamin D sufficient patients | Serum 25- (hydroxide) OH Vitamin D levels >20ng/L undergoing Frozen embryo transfer (Vitamin D levels are measured on the day of embryo transfer) Receives: Procedure: frozen embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
The presence of intrauterine gestational sac at 7 weeks of gestation
Measured: 4 weeks after embryo transfer
Secondary outcomes (2)
implantation rates
number of gestational sacs per transferred embryo.
Measured: 3 weeks after embryo transfer
ongoing pregnancy rates
Pregnancy that had completed ≥20 weeks of gestation
Measured: 18 weeks 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 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 PregnancyStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahceci Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C CELİK, Bahceci Clinic
- Investigators
- mustafa bahceci, Study director, bahceci Fulya IVF center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361710
- Sponsor's protocol ID
- BHC24120209
- Status last verified
- Jan 2016
- First submitted
- 8 Feb 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.
PubMed 22914766
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
- Comparing the Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)
- ClinicalTrials.gov ID
- NCT02361710
- Acronym / sponsor ID
- BHC24120209
- Conditions
- Pregnancy
- Keywords
- Vitamin D, pregnancy rate, eFET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 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
- 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.
The aim of this study is determining the affects of serum vitamin D levels to implantation and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer. Two groups will be identified according to the serum vitamin D levels on eFET transfer day and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared between those groups
Detailed description
In the last decade there have been growing evidence about Vitamin D receptors and their role in female genital tract. But these studies are yet not well designed and the results should be interpreted cautiously. Although some of these studies advocating the Vitamin D deficiency as an negative circumstance on pregnancy rates some of the others don't agree. According to contradictory results understanding the actual role of those receptors needs more observation.
Latest retrospective analyse postulated that, vitamin D deficiency in fresh single embryo transfer cycles may reduce pregnancy rates mediated by endometrium or ovarian reserve and stimulation characteristics.
For this reason the investigators aimed to explore the effect of serum Vitamin D levels on pregnancy rates in infertile population undergoing frozen embryo transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D deficient patients | – | Procedure: frozen embryo transferSerum 25- (hydroxide) OH Vitamin D levels <20ng/L undergoing Frozen embryo transfer (Vitamin D levels are measured on the day of embryo transfer) |
| vitamin D sufficient patients | – | Procedure: frozen embryo transferSerum 25- (hydroxide) OH Vitamin D levels >20ng/L undergoing Frozen embryo transfer (Vitamin D levels are measured on the day of embryo transfer) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women undergoing a frozen ET with 1 Day 5 (blastocyst stage) embryo
Key inclusion criteria (4 listed)
- 18 years to 35 years age, a frozen ET with 1 Day 5 (blastocyst stage) embryo
- Infertile women undergoing ICSI (intracytoplasmic sperm injection) cycle
- Factors affecting fertility are Tubal
- Unexplained or ovulatory disturbances,
Key exclusion criteria (3 listed)
- Need to do Preimplantation Genetic Diagnosis
- Presence of endometriosis and adenomyosis
- Severe male factor infertility
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 |
|---|---|---|
| frozen embryo transfercomparison of groups according to their serum vitamin D levels on frozen embryo transfer day | Procedure or surgery | vitamin D deficient patients, vitamin D sufficient patients |
Primary outcome
clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
The presence of intrauterine gestational sac at 7 weeks of gestation
2 secondary outcomes
implantation rates
Time frame: 3 weeks after embryo transfer
ongoing pregnancy rates
Time frame: 18 weeks after embryo transfer
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 22914766Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.
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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.
mustafa bahceci study director
bahceci Fulya IVF center
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 Pregnancy, 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 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: 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?
clinical pregnancy rate (time frame: 4 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 NCT02361710, 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.