Women Diagnosed With InfertilityNCT06559904
The Effect of the Mediterranean Diet on Fatty Acids in Biological Fluids of Women Undergoing Infertility Treatment
A study testing Mediterranean diet in people with Women Diagnosed With Infertility, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of the Mediterranean diet, which is accepted as one of the adequate and balanced nutrition models today, as well as serum and follicular fluid fatty acid profile and implantation success in women with an age range of 19-40 (years) before infertility treatment. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Women Diagnosed With Infertility
- What is being tested?
- Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 2 Nov 2023
- Phase
- Interventional
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with infertility Women between the ages of 19-40 Women with BMI <30 kg/m² women undergoing assisted reproductive treatment in which updated oocytes and semen be used Women undergoing assisted reproductive treatment (ART), IUI or one of the first 3 IVF/ICSI treatments (number of ART treatments ≤ 3)
Who cannot join
- Women diagnosed with chronic diseases other than infertility Women who smoke and drink alcohol Women on ART who will use frozen eggs or semen Women with BMI >30 kg/m2 at the first measurement Women experiencing communication breakdown/timeout, becoming pregnant, difficulty adhering to a diet program or ART while the intervention is ongoing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dıetary Interventıon in Adherence With The Medıterranean Dıet on Fatty Acid Parameters in Blood and Follicular Fluid Samples and Implantation Success in Women Undergoing Infertility Treatment
The aim of this study was to examine the effect of the Mediterranean diet, which is accepted as one of the adequate and balanced nutrition models today, as well as serum and follicular fluid fatty acid profile and implantation success in women with an age range of 19-40 (years) before infertility treatment. The study was conducted as a prospective and case-control study with a total of 32 volunteer women, 16 in the intervention group and 16 in the control group, who applied to Gazi University Hospital between February 2021 and February 2022.
- Conditions
- Women Diagnosed With Infertility
- Being tested
- Mediterranean diet
- Keywords
- Fatty acids, Folicular Fluid, Implantation, Infertility, Mediterranean Diet, Ratio of ω6/ω3fatty acid
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
The 'Mediterranean Diet Education Document', prepared by the researcher, which includes general information about the characteristics of the Mediterranean diet and the portion sizes that should be followed daily and weekly, and information on how often, how much and when to consume food groups, was provided as a diet education, and information was provided on how to record three-day food consumption.
A nutrition education compatible with the Mediterranean diet, organized by the researcher according to the individual's daily needs, was provided and a sample menu was explained to the individual face to face.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Other | Mediterranean diet was applied to this group according to the needs of the individuals. The explanation was made through the Mediterranean diet training document and sample menu prepared by the researcher. The individuals were asked to apply this diet for 12 weeks. The individuals' compliance with the diet was evaluated with food consumption records in 4-week periods. Blood samples were taken from the individuals at the beginning of the treatment as biological material and at the end, blood samples and follicle fluid samples were collected according to the adjuvant treatment. Fatty acid analyses were performed with gas chromatography. Receives: Other: Mediterranean diet |
| Control group | No intervention | This group did not receive any intervention. Food consumption records, blood samples and follicular fluid samples were taken only once from individuals who came for IVF treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
first meeting
using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days
Measured: through study completion, an average of 1 year
second meeting
An explanation of the individual Mediterranean diet
Measured: through study completion, an average of 1 year
third and forth meeting
recording three-day food intake evaluate adherence to the Mediterranean diet using anthropometric measurements
Measured: through study completion, an average of 1 year
fifth meeting
using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days, collecting follicular fluid samples
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
analysis of blood and follicular fluid samples
Fatty acid analyses of the collected samples were performed by gas chromatography-flame ionization detector (GC-FID) at Gazi University Faculty of Pharmacy.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Feb 2020
- Primary completion1 Feb 2022
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Diagnosed With 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- First, the intervention group was created in the study and the study was completed, then the control group was studied. 5 interviews were conducted with the women in the intervention group and the average time between the first and last interviews was 15.03±1.59 weeks. 2 interviews were conducted with the women included in the control group and the time between these interviews was 1.41±0.53 weeks.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Özge CEMALİ, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559904
- Sponsor's protocol ID
- 47/2020-06
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dıetary Interventıon in Adherence With The Medıterranean Dıet on Fatty Acid Parameters in Blood and Follicular Fluid Samples and Implantation Success in Women Undergoing Infertility Treatment
- ClinicalTrials.gov ID
- NCT06559904
- Acronym / sponsor ID
- 47/2020-06
- Conditions
- Women Diagnosed With Infertility
- Keywords
- Fatty acids, Folicular Fluid, Implantation, Infertility, Mediterranean Diet, Ratio of ω6/ω3fatty acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 19 Aug 2024 (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.
The aim of this study was to examine the effect of the Mediterranean diet, which is accepted as one of the adequate and balanced nutrition models today, as well as serum and follicular fluid fatty acid profile and implantation success in women with an age range of 19-40 (years) before infertility treatment. The study was conducted as a prospective and case-control study with a total of 32 volunteer women, 16 in the intervention group and 16 in the control group, who applied to Gazi University Hospital between February 2021 and February 2022.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First, the intervention group was created in the study and the study was completed, then the control group was studied. 5 interviews were conducted with the women in the intervention group and the average time between the first and last interviews was 15.03±1.59 weeks. 2 interviews were conducted with the women included in the control group and the time between these interviews was 1.41±0.53 weeks.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Other | Other: Mediterranean dietMediterranean diet was applied to this group according to the needs of the individuals. The explanation was made through the Mediterranean diet training document and sample menu prepared by the researcher. The individuals were asked to apply this diet for 12 weeks. The individuals' compliance with the diet was evaluated with food consumption records in 4-week periods. Blood samples were taken from the individuals at the beginning of the treatment as biological material and at the end, blood samples and follicle fluid samples were collected according to the adjuvant treatment. Fatty acid analyses were performed with gas chromatography. |
| Control group | No intervention | –This group did not receive any intervention. Food consumption records, blood samples and follicular fluid samples were taken only once from individuals who came for IVF treatment. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed with infertility Women between the ages of 19-40 Women with BMI <30 kg/m² women undergoing assisted reproductive treatment in which updated oocytes and semen be used Women undergoing assisted reproductive treatment (ART), IUI or one of the first 3 IVF/ICSI treatments (number of ART treatments ≤ 3)
Key exclusion criteria (1 listed)
- Women diagnosed with chronic diseases other than infertility Women who smoke and drink alcohol Women on ART who will use frozen eggs or semen Women with BMI >30 kg/m2 at the first measurement Women experiencing communication breakdown/timeout, becoming pregnant, difficulty adhering to a diet program or ART while the intervention is ongoing
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 |
|---|---|---|
| Mediterranean dietThe 'Mediterranean Diet Education Document', prepared by the researcher, which includes general information about the characteristics of the Mediterranean diet and the portion sizes that should be followed daily and weekly, and information on how often, how much and when to consume food groups, was provided as a diet education, and information was provided on how to record three-day food consumption. A nutrition education compatible with the Mediterranean diet, organized by the researcher according to the individual's daily needs, was provided and a sample menu was explained to the individual face to face. | Other | Mediterranean diet |
Primary outcome
first meeting
Time frame: through study completion, an average of 1 year
using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days
second meeting
Time frame: through study completion, an average of 1 year
An explanation of the individual Mediterranean diet
third and forth meeting
Time frame: through study completion, an average of 1 year
recording three-day food intake evaluate adherence to the Mediterranean diet using anthropometric measurements
fifth meeting
Time frame: through study completion, an average of 1 year
using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days, collecting follicular fluid samples
1 secondary outcome
analysis of blood and follicular fluid samples
Time frame: through study completion, an average of 1 year
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 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet in people with Women Diagnosed With Infertility, run by Trakya University 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: finished, as of the sponsor's last update on 19 Aug 2024. 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?
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?
first meeting (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2024.