Good Clinical Practice Research Articles

Effect of Tiotropium on eye findings in the treatment of chronic obstructive pulmonary disease

BackgroundChronic obstructive pulmonary disease (COPD) is a persistent, chronic inflammatory disease of the lungs. Tiotropium, used in the treatment of COPD, is a muscarinic receptor antagonist that provides long-acting bronchodilation. Our study aimed to investigate the effects of Tiotropium on anterior chamber parameters.MethodsThe study was conducted as an observational cross-sectional and prospectively between October 2023 and April 2024. Patients were examined in three groups: Group 1 consisted of untreated COPD patients; Group 2 consisted of healthy volunteers similar age and gender, and Group 3 included COPD patients receiving Tiotropium 18 mcg via HandiHaler. Anterior chamber parameters, intraocular pressure values, and photopic-mesopic pupil diameters were measured at the initial visit for Group 1 and Group 2 patients, and at the third month of treatment for Group 3 patients.ResultsThirty-six patients were included in each group in the study. No significant differences were observed in ocular findings between the patient and control groups. In COPD patients receiving Tiotropium, narrowing of angle parameters, an increase in photopic-mesopic pupil diameters, and intraocular pressure were observed at the third month of treatment.ConclusionThis study is the first research that investigate the effects of Tiotropium on anterior chamber parameters, pupil diameters, and intraocular pressure in COPD treatment. In conclusion, patients with COPD receiving Tiotropium therapy for three months showed narrowing in angle parameters, an increase in intraocular pressure, and photopic-mesopic pupil diameter; however, no patients developed drug-induced acute angle closure glaucoma.Trial registrationAn independent ethics committee approved the study (Giresun EAH KEAK 2023/180 and 9.10.2023/02) which was performed in accordance with the Declaration of Helsinki, Guidelines for Good Clinical Practice. The study was conducted as prospectively, observational case–control. The Clinical Trial Number obtained for the study is NCT06525051 and was taken on 2024–07-29.

Challenging behaviour, the application of restrictive measures and psychotropic drug prescription in people with intellectual disabilities

BackgroundPrescribing of psychotropic drugs (PDs) and applying restrictive measures are both frequently used in managing challenging behaviour of people with intellectual disabilities (ID), which is not always according to guidelines or good clinical practice. AimsThis study aimed to investigate the potential triangular relationship between challenging behaviour, the application of restrictive measures and PD prescription. Methods and proceduresIn this cross-sectional study, data on challenging behaviour, PD prescription and restrictive measures were collected. We defined and compared four mutually exclusive groups of participants. Outcomes and resultsChallenging behaviour in the group in whom one or more PD were prescribed as a restrictive measures (PDRM) was more severe than in the other three groups. More severe challenging behaviour, a higher number of antipsychotics, antidepressants and anxiolytics/hypnotics prescriptions, a lower dosage, and more application of domotics as restrictive measure was shown in the PDRM compared to the group in whom PDs were prescribed according to guidelines (PDNRM). Conclusions and implicationsWe did not find indications for a triangular relationship of challenging behaviour, the application of restrictive measures and PD prescriptions. Future longitudinal research is needed to better understand this complex relationship and should investigate the indication and the effect of treatment. What this paper adds?This study is a first exploration of the potential triangular relationship between symptoms of challenging behaviour, psychotropic drug (PD) prescription, and the application of restrictive measures. Prescribing PDs and applying restrictive measures are two interventions which are commonly used to manage challenging behaviour in people with intellectual disabilities. Both have been subject of research separately in recent years. However, it is conceivable that the PD prescription in treatments for challenging behaviour could be a substitute for another form of a restrictive measure, for example a physical or mechanical restraint. For this purpose, we defined and compared four mutually exclusive groups of participants. We found no indication for this triangular relationship. On the other hand, we found the highest severity of challenging behaviour in the group who used PDs as restrictive measure next to other restrictive measures. Our results may suggest that both prescribing PDs and applying non-pharmacological restrictive measures are used simultaneously in managing challenging behaviour, are not sufficiently implemented or effective.

Lessons from enriching Tanzania’s clinical research ethics clinical trials oversight and pharmacovigilance through the ASCEND project

Engaging in clinical trials in Africa not only enhances researchers' comprehension of local health concerns but also plays a crucial role in tackling global health challenges. In Tanzania, there has been a surge of clinical research for the past 10 years indicating a need to improve ethical and clinical trial regulatory capacity. Several initiatives to address the clinical trial regulatory and ethics challenges have been done. Lessons from such initiatives are important to inform evidence-based decision-making for sustainability. The ASCEND project with the theme of “Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the Next Level: Fostering Medicine Quality, Safety and Good Clinical Practice (GCP) on Clinical Trials” was implemented in Tanzania Mainland and Zanzibar from November 2020 to December 2023. A thorough review of the project implementation reports and on deliverables was conducted to identify the lessons learned. Inductive content analysis was used to analyze the information. A total of seven lessons were deduced from the reviewed documents. These include capacity building through training on clinical trials review and approval process, research ethics and GCP inspection which cannot be overlooked; engaging the community in reporting adverse drug events is worth considering; digitalization of electronic systems enhances clinical trial control and creates a dynamic regulatory ecosystem; compliance to requirements for clinical trials conduct is enhanced by training of early and mid-career researchers; networking and broad stakeholders’ engagement and participation in ethics and regulations governing clinical trials is a cornerstone for strengthening collaboration between researchers and regulators; the need for electronic systems for monitoring and evaluation of the project is inevitable and the need for adhering to project timelines is crucial for successful implementation of the project. Sustainability is the take-home message from the ASCEND project and should inform stakeholders for future improvement. Continuous investment and advancement in research ethics and regulatory oversight across Africa should be prioritized.

An Example of a Clinical Research Ethics Committee in Türkiye: Types of Studies Analysed, Their Phases and Investigators.

Clinical studies are reviewed by clinical research ethics committees (CRECs) in order to ensure that they are conducted within the framework of good clinical practice and that the rights of volunteers are respected. Research type, department, status, scope, principal investigator's characteristics and CREC decisions were all evaluated. A total of 1044 research applications were found to have been submitted. In addition, 14.6% of the applications were clinical trials and 48.8% were retrospective studies. Of all the researchers, 50.4% of them were found to have indicated an incorrect type of research. The very low number of interventional clinical trials suggests that researchers tended to be hesitant about conducting such trials or did not have the means to do so. The fact that the applications were often submitted by indicating a wrong type of research method also signifies the investigators' lack of knowledge in this regard.

Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

In alignment with the ICH guideline for Good Clinical Practice [ICH E6(R2)], quality tolerance limit (QTL) monitoring has become a standard component of risk-based monitoring of clinical trials by sponsor companies. Parameters that are candidates for QTL monitoring are critical to participant safety and quality of trial results. Breaching the QTL of a given parameter could indicate systematic issues with the trial that could impact participant safety or compromise the reliability of trial results. Methods for QTL monitoring should detect potential QTL breaches as early as possible while limiting the rate of false alarms. Early detection allows for the implementation of remedial actions that can prevent a QTL breach at the end of the trial. We demonstrate that statistically based methods that account for the expected value and variability of the data generating process outperform simple methods based on fixed thresholds with respect to important operating characteristics. We also propose a Bayesian method for QTL monitoring and an extension that allows for the incorporation of partial information, demonstrating its potential to outperform frequentist methods originating from the statistical process control literature.

"Food for Thought": Improving Cognition in People With Schizophrenia.

We have known that cognitive difficulties are related to functional outcomes in schizophrenia for many years. However, we have only paid attention to potential treatments relatively recently, so implementation has been slow. This is a narrative review describing the development of cognitive remediation treatments to improve cognitive skills and their effects on functioning. It also reviews the types of cognitive remediation with some evidence on their effects. Models of treatment have now been clarified and have led to a landmark paper by cognitive remediation experts around the world on the ingredients of cognitive remediation to produce the most benefit. This expert judgement on good clinical practice was justified by a large meta-analysis that supported the extra benefit of the four ingredients: an active therapist, massed practice of cognitive skills, the teaching of cognitive strategies and additional rehabilitation to transfer skills to real life. Although there is evidence of efficacy and of the beneficial therapy ingredients there is little implementation of cognitive remediation, so the establishment of cognitive remediation into mental health services needs an implementation pathway.

Serum immunoglobulin levels in group E of chronic obstructive pulmonary disease: insights for clinical management and immunoglobulin therapy strategies

ObjectiveThe study aimed to characterize serum immunoglobulin (Ig) concentrations and their relationship with clinical and paraclinical features in patients with COPD group E in the stable stage. Additionally, the study focused on evaluating the relationship between serum Ig levels and the risk of exacerbations over the next 12 months, thereby clarifying the role of serum Ig deficiency in affecting the future risk for these patients.MethodsA prospective observational study assessed IgG, IgA, IgM, and IgE levels in 67 COPD patients and 30 healthy controls at Military Hospital 103 from October 2017 to August 2020. Primary outcomes included Ig isotype levels in COPD patients, with secondary outcomes exploring differences compared to controls and associations with clinical variables.ResultsCOPD patients showed significantly lower IgG concentrations and higher IgA levels than controls. IgM and IgE levels did not differ significantly. Subgroup analysis revealed notable decreases in IgG1 and IgG3 concentrations, with 10.4% of patients exhibiting reduced IgG levels and 0.3% diagnosed with common variable immunodeficiency. No significant associations were found between Ig levels and exacerbation risk or clinical variables.ConclusionsSerum IgG and IgM concentrations were significantly reduced in COPD patients compared to normal individuals, with IgG1 and IgG3 concentrations notably low. Serum IgA levels were significantly higher in COPD patients compared with normal controls. However, no significant association was found between Ig concentrations, particularly serum IgG deficiency and its subclasses, with the frequency and risk of exacerbations during 12 months of longitudinal follow-up. Caution is warranted in the use of immunoglobulin therapy in the treatment of COPD patients.Trial registrationAn independent ethics committee approved the study (Ethics Committee of Military Hospital 103 (No. 57/2014/VMMU-IRB), which was performed in accordance with the Declaration of Helsinki, Guidelines for Good Clinical Practice.

Management of patients with neurological diseases considering post-pandemic coronavirus disease 2019 (COVID-19) related risks and dangers - An updated European Academy of Neurology consensus statement.

In October 2020, the European Academy of Neurology (EAN) consensus statement for management of patients with neurological diseases during the coronavirus disease 2019 (COVID-19) pandemic was published. Due to important changes and developments that have happened since then, the need has arisen to critically reassess the original recommendations and address new challenges. In step 1, the original items were critically reviewed by the EAN COVID-19 Task Force. In addition, new recommendations were defined. In step 2, an online survey with the recommendations forged in step 1 was sent to the Managing Groups of all Scientific and Coordinating Panels of EAN. In step 3, the final set of recommendations was made. In step 1, out of the original 36 recommendations, 18 were judged still relevant. They were edited to reflect the advances in knowledge and practice. In addition, 21 new recommendations were formulated to address the new knowledge and challenges. In step 2, out of the 39 recommendations sent for the survey, nine were approved as they were, whilst suggestions for improvement were given for the rest. In step 3, the recommendations were further edited, and some new items were formed to accommodate the participants' suggestions, resulting in a final set of 41 recommendations. This revision of the 2020 EAN Statement provides updated comprehensive and structured guidance on good clinical practice in people with neurological disease faced with SARS-CoV-2 infection. It now covers the issues from the more recent domains of COVID-19-related care, vaccine complications and post-COVID-19 conditions.

The Role of Quality Assurance in Clinical Trials: Safeguarding Data Integrity and Compliance.

Clinical trials, which investigate the effects of drugs in humans, aim to determine safety and efficacy while identifying adverse reactions. Data consistency and subject safety are crucial factors that determine the quality of clinical trials, necessitating overall quality management. There is a growing emphasis on implementing quality systems during the planning stages of clinical trials. Regulatory frameworks have evolved to ensure patient protection and data reliability, underscoring the need for systematic quality management in health research. A clinical trial quality management plan (CTQMP) is essential to describe the tools and methods used to ensure study quality. Globalization has led to an increase in conducting clinical trials in developing nations, presenting challenges due to procedural and ethical disparities. To manage these complexities, outsourcing trial management has become common. Adherence to good clinical practice (GCP) principles, as defined by the International Conference on Harmonization (ICH), is critical for safeguarding participant rights and ensuring credible data. Quality by design (QbD) and quality risk management are now central to clinical trial management, as advocated by the FDA. Technological advancements and robust protocols further enhance trial processes. Effective QA activities, including monitoring and data management, are vital for maintaining compliance, participant safety, and data integrity, highlighting the indispensable role of QA in clinical trial success.

RecurIndex-Guided postoperative radiotherapy with or without Avoidance of Irradiation of regional Nodes in 1–3 node-positive breast cancer (RIGAIN): a study protocol for a multicentre, open-label, randomised controlled prospective, phase III trial

IntroductionPostoperative radiotherapy in patients with breast cancer with one to three lymph node metastases, particularly within the pT1–2N1M0 cohort with a low clinical risk of local–regional recurrence (LRR), has incited...

Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project

BackgroundIt is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal products (CTIMPs), investigators must immediately report to the sponsor any serious adverse event (SAE) that occurs in a site for which they are responsible. It is therefore expected that sponsors provide systems for timely review and reporting should a SAE be classified as a suspected unexpected serious adverse reaction (SUSAR). Challenges arise when data related to adverse events (AEs) needs to be re-entered for SAEs; this can be prone to error and may delay reporting. Additionally, recognising what has changed from an initial SAE report when an investigator responds to queries raised can cause errors.MethodA multi-disciplinary working group came together from a UK academic clinical trials unit (CTU) to establish if an electronic system could be created in the unit’s open-source EDC system—REDCap, to manage SAEs in an efficient way.ResultsA module has been created in REDCap to facilitate electronic SAE reporting: enabling an AE form to automatically trigger an SAE form for any AE which is also a SAE, prepopulating relevant fields of the SAE form, reducing the risk of delay and error when entering data into the SAE form. The system has also been developed with an embedded code to allow for instant visual recognition of any data updated following reporting to allow the sponsor to immediately review and resolve SAEs in a timely manner, complying with UK regulatory reporting. This functionality ‘The eSAE Project’ is now an active project for all of our new trials where data collection is undertaken using the REDCap system.ConclusionThe eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.

Assessing predictors of adequate individual buprenorphine maintenance dosage for the treatment of opioid use disorder: Listening to the patient

ObjectiveDose optimization plays a key role in determining clinical outcomes in patients on opioid agonist treatment (OAT). The objective of this study was to identify the variables independently associated with buprenorphine/naloxone (B/N) dose adequacy in patients with opiate use disorder (OUD). MethodCross-sectional study of a convenience sample of patients with OUD treated with B/N (n = 315) in four regions in Spain. The Opiate Dosage Adequacy Scale (ODAS) was used to determine B/N dose adequacy. The ODAS evaluate the six components of the “dose adequacy” construct, as follows: continued use of heroin; narcotic blockade or crossed tolerance; objective opioid withdrawal symptoms (OWS); subjective OWS; craving for heroin; and overmedication. A binomial logistic regression analysis was performed to identify the variables associated with the condition “ODAS Adequate B/N dose”. Participants completed a battery of instruments to assess sociodemographic, substance use, clinical, and treatment variables. ResultsThe B/N dose was considered adequate in 231 of the 315 participants (73.3 %). Two variables, satisfaction with B/N as a medication (OR=5.764, 95 % CI=2.211-15.030) and patient-perceived participation in B/N dose decisions (OR=1.790, 95 % CI=1221-2623), were independently, significantly, and positively associated with the “ODAS Adequate B/N dose” condition. While the severity of heroin dependence was significantly associated with buprenorphine dose adequacy in the bivariate analyses, significance was lost in the full regression model. ConclusionSatisfaction with B/N as a medication and patient-perceived involvement in the dose decision are associated with clinician-assessed dose adequacy. In the context of good clinical practice, it is important to take into account both of these variables to individualize the prescribed dose through a shared decision-making process.

Emphasizing Patient-Centricity Through a Tailored Training Program to Empower Patients, Advocates, and Ethics Committees in Good Clinical Practice.

Good Clinical Practices (GCP) are essential for patient-centric research. The standard bioethics and GCP training emphasizing a "one-size-fits-all" approach may not adequately equip ethics committee members, especially the lay and social scientist members, towards their critical role in reviewing clinical trials and related documentation. This article explores a patient-centered, patient advocates-driven training program focused on raising awareness about research ethics and GCP among patients, advocates and ethics committee members. A patient advocates-driven program called Patient Advocates for Clinical Research (PACER) conducted trainings focused on GCP for patient-centric research for patients, advocates and ethics committee members. Pre- and post-workshop questionnaires were used to assess the participants' knowledge of GCP. The workshop was attended by 116 participants. Of these 91 consented to participate in questionnaire evaluation that assessed participants' knowledge on ethics committee (EC) functionality, research ethics and data confidentiality. Pre-workshop evaluations highlighted knowledge gaps. Only 16.5% were familiar with the primary ethical consideration for vulnerable populations and 69.2% were knowledgeable about data governance. Post-workshop evaluations demonstrated significant overall response improvement of 5.4% (𝜒2=13.890; p<0.001). The understanding of ethical considerations for vulnerable populations rose by 15.4% (p=0.007), and knowledge of data privacy regulations improved by 11.0% (p=0.041). The workshop under PACER initiative highlighted the knowledge gaps in understanding the EC functionality, research ethics and data confidentiality. The workshop effectively fostered participants' understanding of ethical research practices.

Good clinical practice in India: What a researcher should know?

Good clinical practice in India: What a researcher should know?

The Comparative Efficacy of Intravenous Ibuprofen 400 mg and 800 mg in Acute Mechanical Low Back Pain: A Prospective, Randomized, Double-Blind Clinical Study

Objective: This study aimed to compare the analgesic efficacy of intravenous (IV) ibuprofen at doses of 400 mg and 800 mg for acute mechanical low back pain. Methods: A Prospective, randomized, double-blind controlled clinical trial design was employed. Patients with moderate to severe acute low back pain were recruited from emergency departments. Ethical approval was obtained, and patients provided written consent. The study adhered to ethical guidelines and Good Clinical Practice principles. Results: Of the 144 patients, demographic characteristics were similar between groups. The 800 mg IV ibuprofen group demonstrated superior analgesic efficacy compared to the 400 mg group, with no significant adverse effects reported. Conclusion: The study concludes that the 800 mg IV dose of ibuprofen was more effective in providing analgesia control for patients with acute mechanical low back pain at all time intervals except for the 30th minute.

An Implementation Evaluation of the Smartphone-Enhanced Visual Inspection with Acetic Acid (SEVIA) Program for Cervical Cancer Prevention in Urban and Rural Tanzania.

The World Health Organization (WHO) recommends visual inspection with acetic acid (VIA) for cervical cancer screening (CCS) in lower-resource settings; however, quality varies widely, and it is difficult to maintain a well-trained cadre of providers. The Smartphone-Enhanced Visual Inspection with Acetic acid (SEVIA) program was designed to offer secure sharing of cervical images and real-time supportive supervision to health care workers, in order to improve the quality and accuracy of visual assessment of the cervix for treatment. The purpose of this evaluation was to document early learnings from patients, providers, and higher-level program stakeholders, on barriers and enablers to program implementation. From 9 September to 8 December 2016, observational activities and open-ended interviews were conducted with image reviewers (n = 5), providers (n = 17), community mobilizers (n = 14), patients (n = 21), supervisors (n = 4) and implementation partners (n = 5) involved with SEVIA. Sixty-six interviews were conducted at 14 facilities, in all five of the program regions Results SEVIA was found to be a highly regarded tool for the enhancement of CCS services in Northern Tanzania. Acceptability, adoption, appropriateness, feasibility, and coverage of the intervention were highly recognized. It appeared to be an effective means of improving good clinical practice among providers and fit seamlessly into existing roles and processes. Barriers to implementation included network connectivity issues, and community misconceptions and the adoption of CCS more generally. SEVIA is a practical and feasible mobile health intervention and tool that is easily integrated into the National CCS program to enhance the quality of care.

Intravenous ketamine for emergency department treatment of suicidal ideation in a paediatric population: protocol for a double-blind, randomised, placebo-controlled, parallel-arm pilot trial (KSI study)

IntroductionSuicidal ideation (SI) is a common and severe cause of morbidity in adolescents. Patients frequently present to the emergency department (ED) for care, yet there is no acute therapeutic intervention...

Research in an intercultural context: mediator-investigators of epidemiological health studies, bridges between two worlds.

ContextFrench Guiana is a French overseas department where very different linguistic, cultural and societal populations live together in a small area. Health issues and their specific epidemiological profiles call for research projects crossing several cultures. In this context, health mediators have a role to play in research. The aim of this study was to describe the perceptions, attitudes and opinions on research of mediators and researchers collaborating on research projects, and to describe the strengths and difficulties encountered during this cooperation.MethodsThe Inter-med project was conducted in French Guiana between February 2022 and April 2023 on the base of semi-directive interviews with mediators, or researchers, all working in health research in the intercultural context of French Guiana. The socio-demographic characteristics of the participants were described. An inductive thematic analysis was carried out on all the interviews, and word occurrence analysis on certain themes. The information was triangulated with field coordination notebooks from two epidemiological surveys conducted in French Guiana between 2021 and 2022.ResultsA total of 26 semi-structured interviews were conducted and 1,328 notebook pages analyzed. Mediation was described as an indispensable interface between the world of research and that of the population targeted by a survey. Mediators have a role to play at different stages of projects, in respect of good clinical practice, ethics and legislation. They act as interfaces between languages, concepts and representations. Their profession remains under-defined and under-dimensioned. The jobs offered are often precarious. Mediation work is emotionally costly, calls on soft skills and requires a combination of rigor and flexibility. All these aspects are implemented in the specific world of research, where there are common concepts and divergent perceptions. Researchers and mediators converge on a common goal: improving health.ConclusionThis study covers several aspects of the development and implementation of research projects. Respect for good clinical practice and people, transparency and data quality are redundant concerns, and this study touches on ethnocentrism, stigmatization and cultural representations. This study points out that the integration and recognition of mediators could be beneficial in research conducted in a cross-cultural context.

Questionnaire survey and analysis of drug clinical research implementation capabilities of breast cancer treatment departments in Chinese hospitals

BackgroundClinical research competence determines the quality of clinical research and the reliability of research findings. We aimed to explore the clinical research implementation capabilities of breast cancer treatment departments in China. MethodsThis was a department-based cross-sectional study conducted in the form of electronic questionnaires on the Wenjuanxing platform from 7th August to 31st August 2023 among hospitals from the first batch of breast cancer standardized diagnosis and treatment quality control pilot centers in China. ResultsA total of 127 questionnaires from 122 hospitals were ultimately included in the analysis. Medical personnel involved in the clinical research of 118 (92.9 %) departments received good clinical practice (GCP) training. The steps of the approval process from research initiation to completion lasted 2–4 weeks or longer. The majority of departments initiated or participated in 2 or fewer clinical research projects over the past year. Among the differences between different departments, the Department of Medical Oncology had a better qualification profile and process and greater number of initiated and participated clinical studies than did the Department of Surgical Oncology. For needs and problems, most of the departments were strongly willing to undertake clinical research and receive professional training; the most common problem in the process of conducting studies was patient recruitment. ConclusionsMost departments generally exhibited complete capabilities for implementing clinical research. Improvements in implementation efficiency, quality of research and patient recruitment are still needed. Professional training and communication, as well as the recommendation of clinical research, are required in future development.

P-609 Impact of low versus air oxygen tension on the oocyte maturation in PCOS women undergoing capacitation IVM: a sibling oocyte pilot study

Abstract Study question Does low or air oxygen tension improve the oocyte maturation rate in biphasic capacitation IVM (CAPA-IVM)? Summary answer Low oxygen tension resulted in a lower maturation rate and two-pronuclei fertilization rate compared with air oxygen tension in the CAPA-IVM culture. What is known already CAPA-IVM, with a pre-maturation step, improves the competence of oocytes matured in-vitro. The current CAPA-IVM culture condition is under air oxygen concentration. However, the impact of oxygen tension on in-vitro oocyte maturation needs to be better understood, and it remains uncertain whether the maturation process aligns with in-vivo conditions. Study design, size, duration A sibling oocyte pilot study of 416 cumulus-oocyte complexes (COCs) recruited from fifteen polycystic ovary syndrome (PCOS) women was performed at IVFMD, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Vietnam from November 2023 to January 2024. The study was approved by the Institutional Ethics Committee (22/23/DD-BVMD, dated October 12th, 2023) and conducted according to Good Clinical Practice and Declaration of Helsinki 2002 principles. All participants provided written informed consent. Participants/materials, setting, methods Women (18–37 years) diagnosed with PCOS undergoing CAPA-IVM were recruited. At collection, COCs from each woman were divided into two groups based on the oxygen tension used in the two steps of CAPA-IVM culture, low oxygen tension (5% O2, 6% CO2 at 37 °C) and air oxygen tension (20% O2, 6% CO2 at 37 °C). Embryos were cultured to blastocyst stage. Primary outcome was the oocyte maturation rate. Secondary outcomes were embryology outcomes. Main results and the role of chance A total of 416 COCs from fifteen eligible women were assigned to the low oxygen (207 COCs) and air oxygen tension (209 COCs) groups. Mean age and body max index were 29.0±2.5 years and 22.6±2.6, respectively. The maturation rate was significantly lower in the low oxygen group compared to the air oxygen group (54.1% vs. 66.5%, p = 0.01, respectively). The two-pronuclei fertilization rate per COC was significantly decreased in the low oxygen group compared to the air oxygen group (35.7% vs. 49.3%, p = 0.005, respectively). Rates of day-3 embryos, blastocyst formation rate, and good quality blastocyst rate were also lower but not significant in the low oxygen tension group as compared to the air oxygen tension group. Limitations, reasons for caution The study’s limitations include a relatively small sample size and a single ethnicity group. There was a lack of data on clinical outcomes after transferring embryos from the study. Wider implications of the findings Oocyte maturation rate and two-pronuclei fertilization rate were significantly lower when oxygen tension was reduced in the process of CAPA-IVM culture. Therefore, air oxygen tension should be considered as a standard for oocyte culture in the pre-maturation step of CAPA-IVM. Trial registration number NCT06087354