IVFOxidStressHRNCT05575739
Evaluation of the Relationship Between Oxidative Stress and Human Reproduction
An observational study of IVF and Pregnancy, run by Calla IVF Center at 1 site in Romania.
Trial summary
The aim of the study is to investigate the role of oxidative stress in female infertility and the relationship between the stress as it is illustrated by questionnaires, serum markers, follicular fluid markers, and ovarian response in assisted reproduction. Read more about this study
- Who is it for?
- Ages 20 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF, Pregnancy, Oxidative Stress
- What is being tested?
- Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )
- How many people
- 80 participants
- Where
- 1 siteRomania
- Study dates
- 14 Feb 2021to 14 Feb 2023
- 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 20 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Population is homogeneous. Study group are females that struggle with infertility.
Who may be able to join
- all patients with the Infertility diagnosis (trying to conceive for over 12 months having regular unprotected sexual intercourse) and having an ovarian puncture during an IVF procedure
Who cannot join
- patients that need sperm and egg donors
- patients that refuse being enrolled in the study
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Calla Ivf
Oradea, Bihor County
Anca Huniadi
About this study
Official title: Evaluation of the Relationship Between the Psychological Level of Stress, Serum Oxidative Stress, Follicular Fluid Oxidative Stress, Ovarian Hormones and Response to Gonadotropin Stimulation During IVF (in Vitro Fertilisation) Procedures.
The aim of the study is to investigate the role of oxidative stress in female infertility and the relationship between the stress as it is illustrated by questionnaires, serum markers, follicular fluid markers, and ovarian response in assisted reproduction.
Read the detailed description
The investigators included patients that underwent an in vitro fertilization procedure in CALLA IVF Clinic.
All the patients had at least one ovarian stimulation cycle. In day two of the menstrual cycle the patients had a blood test for serum FSH(follicular stimulant hormone) E2 (estradiol) LH(Luteinizing hormone) and P(progesterone) as well as an ultrasound to asses the antral follicular count(AFC). The same day(day 2) the stimulation protocol begins. These four parameters are tested few times during the stimulation. The average stimulation protocol is 11 days. When the serum levels of hormones and ultrasound measurements of follicles reach the needed values (E2>1000pg/mL and follicles over 17mm) the hCG trigger is received. Transvaginal ultrasound guided oocyte retrieval was performed at 34-36 hours later. ICSI (intracitoplasmatic sperm injection) was performed and the fertilization by the presence of two pronuclei was confirmed 16-20 hours after the injection.
Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.
The parameters that are being observed are: number of oocytes, fertilisation rate and number of embryos.
- Conditions
- IVF, Pregnancy, Oxidative Stress, Fertility Disorders
- Being tested
- Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )
- Keywords
- Oxidative Stress, In vitro fertilisation, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )Diagnostic test
Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.
| Study group | Role | What they receive |
|---|---|---|
| Male factor | Couples that have just the male factor as cause of infertility Receives: Diagnostic Test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins ) | |
| Other causes of infertility | diminished ovarian reserve polycystic ovarian syndrome unexplained infertility tubal factor Receives: Diagnostic Test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular fluid and serum: malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins on the day of ovarian puncture in in vitro fertilisation procedures.
The primary outcome of the study is to establish the correlation between the oxidative stress markers and the ovarian response and the IVF(in vitro fertilization) success (number of oocytes retrieved, mature oocytes, fertilization rate, blastulation rate).
Measured: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
Correlation between the levels of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) and the cause of infertility.
The values of malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins in patients going trough an IVF procedure and the way the are associated with the cause of infertility. If the values differ between the two groups and if they impact the outcome of the IVF procedure (number of oocytes retrieved, mature oocytes, fertilization rate, blastulation rate) in either group.
Measured: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
Secondary outcomes (3)
Questionnaire of psychological evaluation of perception of the day to day level of stress and the association with the levels of oxidative stress in the day of ovarian puncture.
Perceived stress questionnaire - having 3 levels of stress according to the points in each question.
Measured: 1-2 hours
Correlation between maternal age and ovarian reserve and the values of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) in the ovarian stimulation outcome.
The values of antimullerian hormone in ng/mL and the values of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) and the succes rate of the IVF procedure.
Measured: 18 months
Correlation between HOMA-IR value (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5), insulino-resistance and the body mass index, values of oxidative stress markers and ovarian stimulation outcome.
HOMA-IR value and body mass index in patients during the cycle of ovarian stimulation for IVF procedure.
Measured: Day 1 of ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start14 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion14 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calla IVF Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huniadi Anca Carmen, Calla IVF Center
- Investigators
- Anca Huniadi, Study chair, CALLA IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575739
- Sponsor's protocol ID
- CallaIVF
- Acronym
- OxidStressHR
- Status last verified
- Oct 2022
- First submitted
- 16 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between the Psychological Level of Stress, Serum Oxidative Stress, Follicular Fluid Oxidative Stress, Ovarian Hormones and Response to Gonadotropin Stimulation During IVF (in Vitro Fertilisation) Procedures.
- ClinicalTrials.gov ID
- NCT05575739
- Acronym / sponsor ID
- OxidStressHR / CallaIVF
- Conditions
- IVF, Pregnancy, Oxidative Stress, Fertility Disorders
- Keywords
- Oxidative Stress, In vitro fertilisation, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Calla IVF CenterUniversity, hospital or other
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 14 Feb 2023 (estimated)
- First posted
- 12 Oct 2022 (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 the study is to investigate the role of oxidative stress in female infertility and the relationship between the stress as it is illustrated by questionnaires, serum markers, follicular fluid markers, and ovarian response in assisted reproduction.
Detailed description
The investigators included patients that underwent an in vitro fertilization procedure in CALLA IVF Clinic.
All the patients had at least one ovarian stimulation cycle. In day two of the menstrual cycle the patients had a blood test for serum FSH(follicular stimulant hormone) E2 (estradiol) LH(Luteinizing hormone) and P(progesterone) as well as an ultrasound to asses the antral follicular count(AFC). The same day(day 2) the stimulation protocol begins. These four parameters are tested few times during the stimulation. The average stimulation protocol is 11 days. When the serum levels of hormones and ultrasound measurements of follicles reach the needed values (E2>1000pg/mL and follicles over 17mm) the hCG trigger is received. Transvaginal ultrasound guided oocyte retrieval was performed at 34-36 hours later. ICSI (intracitoplasmatic sperm injection) was performed and the fertilization by the presence of two pronuclei was confirmed 16-20 hours after the injection.
Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve.
The parameters that are being observed are: number of oocytes, fertilisation rate and number of embryos.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male factor | – | Diagnostic Test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )Couples that have just the male factor as cause of infertility |
| Other causes of infertility | – | Diagnostic Test: Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )diminished ovarian reserve polycystic ovarian syndrome unexplained infertility tubal factor |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Population is homogeneous. Study group are females that struggle with infertility.
Key inclusion criteria (1 listed)
- all patients with the Infertility diagnosis (trying to conceive for over 12 months having regular unprotected sexual intercourse) and having an ovarian puncture during an IVF procedure
Key exclusion criteria (2 listed)
- patients that need sperm and egg donors
- patients that refuse being enrolled in the study
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 |
|---|---|---|
| Measurement of oxidative stress levels (Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins )Follicular fluid and serum were obtained within 1 hour of oocyte recovery. Considerable care was taken to pool follicular fluid uncontaminated with blood. The samples were processed by centrifuge and 1-mL aliquots stored ar -80ºC until assay. Malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonylated proteins were measured from follicular fluid and plasma according to manufacturer's protocol. This assay has been described as highly sensitive. Data were expressed as millimoles per liter from the reference curve. | Diagnostic test | Male factor, Other causes of infertility |
Primary outcome
Follicular fluid and serum: malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins on the day of ovarian puncture in in vitro fertilisation procedures.
Time frame: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
The primary outcome of the study is to establish the correlation between the oxidative stress markers and the ovarian response and the IVF(in vitro fertilization) success (number of oocytes retrieved, mature oocytes, fertilization rate, blastulation rate).
Correlation between the levels of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) and the cause of infertility.
Time frame: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)
The values of malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins in patients going trough an IVF procedure and the way the are associated with the cause of infertility. If the values differ between the two groups and if they impact the outcome of the IVF procedure (number of oocytes retrieved, mature oocytes, fertilization rate, blastulation rate) in either group.
3 secondary outcomes
Questionnaire of psychological evaluation of perception of the day to day level of stress and the association with the levels of oxidative stress in the day of ovarian puncture.
Time frame: 1-2 hours
Correlation between maternal age and ovarian reserve and the values of oxidative stress markers (malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins) in the ovarian stimulation outcome.
Time frame: 18 months
Correlation between HOMA-IR value (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5), insulino-resistance and the body mass index, values of oxidative stress markers and ovarian stimulation outcome.
Time frame: Day 1 of ovarian stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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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.
Anca Huniadi study chair
CALLA IVF
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 IVF and Pregnancy, run by Calla IVF Center at 1 site in Romania.
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 2 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 12 Oct 2022. 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 Romania. 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 Ioana Alexandra Zaha (+040722639827, drzahaioana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular fluid and serum: malondialdehide, glutathione disulphate, total antioxidant capacity, superoxide dismutase and carbonated proteins on the day of ovarian puncture in in vitro fertilisation procedures. (time frame: 7 days (from ovulation trigger to day 5 embryo, meaning blastocyst)). The study lists 2 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 12 Oct 2022.