Pregnancy OutcomeNCT04515134
Assessment of Follicular Fluid Level of Coenzyme Q10 in Women Undergoing ICSI
An observational study of Pregnancy Outcome, run by South Valley University at 1 site in Egypt.
Trial summary
The aim of this study to assess the follicular fluid level of coenzyme Q10 in women undergoing intracytoplasmic sperm injection (ICSI) and its impact on pregnancy outcome. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcome
- What is being tested?
- assessment of follicular level of coenzyme Q10 in the ovaries in females undergoing ICSI
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2021to 10 Sep 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This work will be conducted on normal and poor responder women undergoing ICSI procedure in ART unit in Obstetrics and Gynaecology department, South Valley University hospital female patient aged 20-42 years. poor responders have at least 2 of the following features: 1. advanced maternal age (40 years or more). 2. previous poor ovarian response (3 or less oocyte retrieved following stimulation). 3. abnormal ovarian reserve teseting (AFC 5-7 or AMH 0.5-1).
Who may be able to join
- Patient age 20-42 years.
- Normal and Poor responders women undergoing ICSI procedure.
Who cannot join
- Hyper responder patients as polycystic ovarian syndrome (PCOs) patients.
- Endocrine or metabolic diseases including hyperprolactinoma, hypothyroidism and hyperthyroidism, DM and adrenal disease
- Patients with severe male factor or Y chromosome abnormality.
- Patients with systemic disease such as chronic renal disease, chronic liver disease and systemic lupus disease.
- patients with uterine cavity pathology or abnormality (endometrial polyp, myoma, hyperplasia, congenital abnormality) detected by trasvaginal 3-dimentional ultrasound or office hysteroscopy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Mohamed Atef
Alexandria, aAlexandria, 21515
basam M Atef, brothere, +201000194343, basamatef89@gmail.com
MAI MO mahmoud, wife, +201069201049, maimokh1990@gmail.com
About this study
Official title: Follicular Fluid Coenzyme Q10 Level in Women Undergoing Intracytoplasmic Sperm Injection
The aim of this study to assess the follicular fluid level of coenzyme Q10 in women undergoing intracytoplasmic sperm injection (ICSI) and its impact on pregnancy outcome.
Read the detailed description
ICSI was first applied to human gametes in 1988, it was first used in cases of fertilization failure after standard IVF or when few sperm cells were available. The first pregnancies were reported in Belgium in 1992.It is a part of an in vitro fertilization (IVF) cycle and refers to a technique in which a single sperm is injected directly into the cytoplasm of a mature oocyte (Palermo et al.,1992).
Oocyte quality remains the most important issue during in vitro fertilization (IVF) cycles, it is affected mainly by age of woman and ovarian reserve (Trifunovic et al., 2004).
Oocyte maturation is a complex process including nuclear and cytoplasmic components. Mitochondria which is in the cytoplasm is the key regulator of energy production via oxidative phosphorylation process which is extremely important in oocyte maturation process. Any problem during oxidative phosphorylation might affect both the quality and DNA content of the oocytes (Ben-Meir et al., 2015).
Oxidative phosphorylation involves the action of the mitochondrial respiratory chain which consists of four complexes that are located in the inner mitochondrial membrane (May-Panloup et al., 2007). These are the NAD-linked dehydrogenase, Flavoproteins, Co-enzyme Q10, and cytochromes. Coenzyme Q10 (Ubiquinone) is structurally similar to vitamin E and vitamin K. It acts as a carrier of proton (H+) from flavoproteins to cytochrome (Bentinger et al., 2007).
Coenzyme Q10 is essential for stability and action of complex III (May-Panloup et al., 2007). It also participates in the transport of protons in the mitochondria to maintain the membrane potential and drive ATP formation through ATP synthetase so it has a critical role in cell growth and energy metabolism. One of the most important factors during oogenesis and oocyte maturation is energy consumption so CoQ10 was reported to improve development, hatching, cell proliferation, and ATP content of in vitro-produced bovine embryos (Gendelman et al., 2012; Stojkovic et al., 1999).
Coenzyme Q10 is a commonly used antioxidant supplement in multiple clinical conditions like diabetes, cancer, and cardiovascular diseases. Also, it was shown that Coenzyme Q10 improves sperm motility, semen quality, and pregnancy rate (Garrido-Maraver et al., 2014). Recently Bentov et al. reported that the use of coenzyme Q10 supplementation resulted in reduced aneuploidy and increased pregnancy rate however it is not clinically significant (Bentov et al., 2014).
Several studies reported that pretreatment with CoQ10 could improve ovarian response to stimulation and embryological parameters in women with poor ovarian reserve in IVF-ICSI cycles, however their results are conflicting so further work is needed to determine whether there is an effect on clinical endpoints (Akarsu et al., 2017). In our study we will investigate the relationship between follicular fluid level of Coenzyme Q10 and clinical pregnancy rate (Xu et al., 2018).
- Conditions
- Pregnancy Outcome
- Being tested
- assessment of follicular level of coenzyme Q10 in the ovaries in females undergoing ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of follicular level of coenzyme Q10 in the ovaries in females undergoing ICSIDiagnostic test
human coenzyme Q10 (CoQ10) ELISA kit
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
clinical pregnancy rate following the intracytoplasmic sperm injection (ICSI) and its relation to follicular fluid coenzyme Q10.
Measured: baseline
Secondary outcomes (1)
implantation rate
Implantation rate and assessment of embroys quality according to Istanbul consensus for embryo quality assessment (Balban et al., 2011).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start14 Sep 2021
- Primary completion5 Aug 2022 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy OutcomeStudies 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
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Atef Mohamed, South Valley University
- Investigators
- mahmoud s mowad, MD, Study chair, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515134
- Sponsor's protocol ID
- follicular fluid Coenzyme Q10
- Status last verified
- May 2022
- First submitted
- 13 Aug 2020
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akarsu S, Gode F, Isik AZ, Dikmen ZG, Tekindal MA. The association between coenzyme Q10 concentrations in follicular fluid with embryo morphokinetics and pregnancy rate in assisted reproductive techniques. J Assist Reprod Genet. 2017 May;34(5):599-605. doi: 10.1007/s10815-017-0882-x. Epub 2017 Feb 9.
PubMed 28185121Ben-Meir A, Burstein E, Borrego-Alvarez A, Chong J, Wong E, Yavorska T, Naranian T, Chi M, Wang Y, Bentov Y, Alexis J, Meriano J, Sung HK, Gasser DL, Moley KH, Hekimi S, Casper RF, Jurisicova A. Coenzyme Q10 restores oocyte mitochondrial function and fertility during reproductive aging. Aging Cell. 2015 Oct;14(5):887-95. doi: 10.1111/acel.12368. Epub 2015 Jun 26.
PubMed 26111777Bentov Y, Hannam T, Jurisicova A, Esfandiari N, Casper RF. Coenzyme Q10 Supplementation and Oocyte Aneuploidy in Women Undergoing IVF-ICSI Treatment. Clin Med Insights Reprod Health. 2014 Jun 8;8:31-6. doi: 10.4137/CMRH.S14681. eCollection 2014.
PubMed 24987272Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.
PubMed 21502182
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Fluid Coenzyme Q10 Level in Women Undergoing Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT04515134
- Acronym / sponsor ID
- follicular fluid Coenzyme Q10
- Conditions
- Pregnancy Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 5 Aug 2022 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 17 Aug 2020 (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 to assess the follicular fluid level of coenzyme Q10 in women undergoing intracytoplasmic sperm injection (ICSI) and its impact on pregnancy outcome.
Detailed description
ICSI was first applied to human gametes in 1988, it was first used in cases of fertilization failure after standard IVF or when few sperm cells were available. The first pregnancies were reported in Belgium in 1992.It is a part of an in vitro fertilization (IVF) cycle and refers to a technique in which a single sperm is injected directly into the cytoplasm of a mature oocyte (Palermo et al.,1992).
Oocyte quality remains the most important issue during in vitro fertilization (IVF) cycles, it is affected mainly by age of woman and ovarian reserve (Trifunovic et al., 2004).
Oocyte maturation is a complex process including nuclear and cytoplasmic components. Mitochondria which is in the cytoplasm is the key regulator of energy production via oxidative phosphorylation process which is extremely important in oocyte maturation process. Any problem during oxidative phosphorylation might affect both the quality and DNA content of the oocytes (Ben-Meir et al., 2015).
Oxidative phosphorylation involves the action of the mitochondrial respiratory chain which consists of four complexes that are located in the inner mitochondrial membrane (May-Panloup et al., 2007). These are the NAD-linked dehydrogenase, Flavoproteins, Co-enzyme Q10, and cytochromes. Coenzyme Q10 (Ubiquinone) is structurally similar to vitamin E and vitamin K. It acts as a carrier of proton (H+) from flavoproteins to cytochrome (Bentinger et al., 2007).
Coenzyme Q10 is essential for stability and action of complex III (May-Panloup et al., 2007). It also participates in the transport of protons in the mitochondria to maintain the membrane potential and drive ATP formation through ATP synthetase so it has a critical role in cell growth and energy metabolism. One of the most important factors during oogenesis and oocyte maturation is energy consumption so CoQ10 was reported to improve development, hatching, cell proliferation, and ATP content of in vitro-produced bovine embryos (Gendelman et al., 2012; Stojkovic et al., 1999).
Coenzyme Q10 is a commonly used antioxidant supplement in multiple clinical conditions like diabetes, cancer, and cardiovascular diseases. Also, it was shown that Coenzyme Q10 improves sperm motility, semen quality, and pregnancy rate (Garrido-Maraver et al., 2014). Recently Bentov et al. reported that the use of coenzyme Q10 supplementation resulted in reduced aneuploidy and increased pregnancy rate however it is not clinically significant (Bentov et al., 2014).
Several studies reported that pretreatment with CoQ10 could improve ovarian response to stimulation and embryological parameters in women with poor ovarian reserve in IVF-ICSI cycles, however their results are conflicting so further work is needed to determine whether there is an effect on clinical endpoints (Akarsu et al., 2017). In our study we will investigate the relationship between follicular fluid level of Coenzyme Q10 and clinical pregnancy rate (Xu et al., 2018).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This work will be conducted on normal and poor responder women undergoing ICSI procedure in ART unit in Obstetrics and Gynaecology department, South Valley University hospital female patient aged 20-42 years. poor responders have at least 2 of the following features: 1. advanced maternal age (40 years or more). 2. previous poor ovarian response (3 or less oocyte retrieved following stimulation). 3. abnormal ovarian reserve teseting (AFC 5-7 or AMH 0.5-1).
Key inclusion criteria (2 listed)
- Patient age 20-42 years.
- Normal and Poor responders women undergoing ICSI procedure.
Key exclusion criteria (5 listed)
- Hyper responder patients as polycystic ovarian syndrome (PCOs) patients.
- Endocrine or metabolic diseases including hyperprolactinoma, hypothyroidism and hyperthyroidism, DM and adrenal disease
- Patients with severe male factor or Y chromosome abnormality.
- Patients with systemic disease such as chronic renal disease, chronic liver disease and systemic lupus disease.
- patients with uterine cavity pathology or abnormality (endometrial polyp, myoma, hyperplasia, congenital abnormality) detected by trasvaginal 3-dimentional ultrasound or office hysteroscopy.
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 |
|---|---|---|
| assessment of follicular level of coenzyme Q10 in the ovaries in females undergoing ICSIhuman coenzyme Q10 (CoQ10) ELISA kit | Diagnostic test | – |
Primary outcome
clinical pregnancy rate
Time frame: baseline
clinical pregnancy rate following the intracytoplasmic sperm injection (ICSI) and its relation to follicular fluid coenzyme Q10.
1 secondary outcome
implantation rate
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 28185121Akarsu S, Gode F, Isik AZ, Dikmen ZG, Tekindal MA. The association between coenzyme Q10 concentrations in follicular fluid with embryo morphokinetics and pregnancy rate in assisted reproductive techniques. J Assist Reprod Genet. 2017 May;34(5):599-605. doi: 10.1007/s10815-017-0882-x. Epub 2017 Feb 9.
- Background: PubMed 26111777Ben-Meir A, Burstein E, Borrego-Alvarez A, Chong J, Wong E, Yavorska T, Naranian T, Chi M, Wang Y, Bentov Y, Alexis J, Meriano J, Sung HK, Gasser DL, Moley KH, Hekimi S, Casper RF, Jurisicova A. Coenzyme Q10 restores oocyte mitochondrial function and fertility during reproductive aging. Aging Cell. 2015 Oct;14(5):887-95. doi: 10.1111/acel.12368. Epub 2015 Jun 26.
- Background: PubMed 24987272Bentov Y, Hannam T, Jurisicova A, Esfandiari N, Casper RF. Coenzyme Q10 Supplementation and Oocyte Aneuploidy in Women Undergoing IVF-ICSI Treatment. Clin Med Insights Reprod Health. 2014 Jun 8;8:31-6. doi: 10.4137/CMRH.S14681. eCollection 2014.
- Background: PubMed 21502182Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.
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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.
mahmoud s mowad, MD study chair
South Valley University
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 Outcome, run by South Valley University at 1 site in Egypt.
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 2 inclusion and 5 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 18 May 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 Egypt. 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 Mohamed Mohamed a Elzarka, MSCc (+201021164099, mohamedelzarka@med.svu.edu.eg), 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: baseline). 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 NCT04515134, which also lists 4 linked publications.
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 18 May 2022.