An interventional study of Standard Treatment for PCOS-Induced Infertility and Counselling-Integrated Standard Care for PCOS-Induced Infertility in Infertility and Poly Cystic Ovary Syndrome, sponsored by Universiti Sains Malaysia. Completed at 4 sites in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and is associated with metabolic, reproductive and mental health complications. Its prevalence has been reported to be between 5% and 15% in different studies, showcasing its significant impact on the reproductive health of Chinese women. A holistic approach to PCOS treatment that integrates physical, emotional, and mental health is lacking in China. The integration of counseling and personalized care into existing healthcare frameworks may have economic implications on patients with PCOS-induced infertility.
This study aimed to compare the effectiveness of the counselling, personalized care, and counseling-personalized care-integrated interventions versus the current module on the clinical outcomes over six months among patients of PCOS-induced infertility. The primary outcomes are menstrual cycle, hormonal parameters, metabolic parameters, and biochemical pregnancy. The secondary outcomes include anxiety and depression, sleep quality, and patient satisfaction. This study also explored the perceived challenges and barriers among patients with PCOS-induced infertility and healthcare providers involved in counseling-personalized care-integrated interventions in China.
The mixed-method sequential interpretative design was applied. The quantitative component involved a non-randomized controlled trial. A total of 192 patients were recruited by convenient sampling from reproductive medicine centers of four hospitals in Shandong Province. One hospital implemented each module. Data has been collected through a review of medical records and questionnaires. Descriptive statistical and repeated measure analysis of variance has been applied using SPSS version 28.0. The qualitative component involved the phenomenological approach of in-depth interviews of patients and healthcare providers involved in the counseling-personalized care-integrated interventions. Approximately 36 respondents were invited for online interviews via purposive sampling. A thematic analysis has been performed using Nvivo version 14.
The following documents have been approved for use in the study.
1. Research Proposal
In addition to the above mentioned documents, the following technical documents were included in the review on which this approval was based:
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 192 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Women of reproductive age with PCOS-induced infertility in the four above-mentioned hospitals, with the following inclusion, exclusion, and withdrawal criteria:
Inclusion Criteria:
Exclusion Criteria:
Withdrawal Criteria:
Participants receive standard clinical treatment for PCOS-induced infertility following Chinese clinical guidelines. Interventions include lifestyle management, routine medication guidance, laparoscopic ovarian puncture (for eligible patients), and traditional Chinese medicine care (acupuncture, cupping, moxibustion). No additional psychological counselling or personalized care is provided.
Behavioral: Standard Treatment for PCOS-Induced Infertility
This arm is based on the standard treatment (same as STI arm) and adds structured psychological counseling. Interventions include cathartic therapy, cognitive behavioral reconstruction, relaxation training, and positive reinforcement for patients with elevated SAS/SDS scores, provided by professional mental health personnel.
Behavioral: Standard Treatment for PCOS-Induced Infertility · Behavioral: Counselling-Integrated Standard Care for PCOS-Induced Infertility
Participants receive the same standard treatment as the STI group plus individualized personalized care, including tailored diet plans, exercise prescription and regular follow-up.
Behavioral: Standard Treatment for PCOS-Induced Infertility · Behavioral: Personalized Care-Integrated Intervention (PII)
Participants receive the same standard treatment as the STI group, combined with both psychological counselling and individualized personalized care.
Behavioral: Standard Treatment for PCOS-Induced Infertility · Behavioral: Integrated Counselling & Personalized Care for PCOS-Induced Infertility
Standard clinical care for women with PCOS-related infertility following Chinese clinical guidelines. It includes lifestyle guidance, hormone-regulating medication, laparoscopic ovarian puncture for eligible patients, and traditional Chinese medicine care (acupuncture, cupping, moxibustion).
Structured psychological counselling, stress management training and emotional support for infertile women with PCOS, delivered by trained reproductive nursing staff.
Individualized care plan based on patients' metabolic status, menstrual characteristics and fertility goals, including tailored diet prescription, personalized exercise scheme and regular follow-up.
Integrated intervention combining structured psychological counselling and individualized personalized care, simultaneously addressing psychological distress and self-management of metabolic and reproductive health.
Biochemical pregnancy rate
The proportion of participants with biochemical pregnancy. Biochemical pregnancy is defined as a positive serum β-hCG result above the institutional reference threshold for pregnancy.
Time frame: 6 months after the start of intervention
Menstrual cycle regularity
Proportion of participants with regular menstrual cycles, defined as cycle length between 21 and 35 days. Cycle length is calculated from the first day of one menstruation to the first day of the subsequent menstruation.
Time frame: 6 months after the start of intervention
Serum testosterone level
Serum testosterone level detected by standard biochemical laboratory assay.
Time frame: 6 months after the start of intervention
Serum estradiol level
Serum estradiol level detected by standard biochemical laboratory assay.
Time frame: 6 months after the start of intervention
Serum progesterone level
Serum progesterone level detected by standard biochemical laboratory assay.
Time frame: 6 months after the start of intervention
Serum luteinizing hormone (LH) level
Serum luteinizing hormone level detected by standard biochemical laboratory assay.
Time frame: 6 months after the start of intervention
Serum follicle-stimulating hormone (FSH) level
Serum follicle-stimulating hormone concentration detected by standard biochemical laboratory assay.
Time frame: 6 months after the start of intervention
Body mass index (BMI)
Body mass index (BMI, unit: kg/m²), calculated as weight in kilograms divided by height in meters squared.
Time frame: 6 months after the start of intervention
Anxiety score assessed by Self-Rating Anxiety Scale (SAS)
Anxiety is assessed by the validated Chinese version of the Self-Rating Anxiety Scale (SAS); higher scores indicate more severe anxiety symptoms.
Time frame: 6 months after the start of intervention
Depression score measured by Self-Rating Depression Scale (SDS)
Depression is assessed by the validated Chinese version of the Self-Rating Depression Scale (SDS); higher scores indicate more severe depressive symptoms.
Time frame: 6 months after the start of intervention
Sleep quality score measured by Self-Rating Scale of Sleep (SRSS)
Sleep quality is assessed by the Chinese Self-Rating Scale of Sleep (SRSS), a validated 10-item self-report scale; higher total scores indicate worse sleep disturbance.
Time frame: 6 months after the start of intervention
Life satisfaction score measured by Satisfaction with Life Scale (SWLS)
Subjective life satisfaction is evaluated using the validated Satisfaction with Life Scale (SWLS); higher scores reflect greater life satisfaction.
Time frame: 6 months after the start of intervention
Patient satisfaction score measured by Short-form Patient Satisfaction Questionnaire (PSQ-18)
Patient satisfaction is assessed using the Chinese adapted version of PSQ-18; higher scores represent higher satisfaction with healthcare services.
Time frame: 6 months after the start of intervention
To explore the challenges and barriers faced by the patients undergoing counselling personalized care integrated intervention.
Phase 2 qualitative study. Phenomenological in-depth semi-structured interviews will be conducted among PCOS-induced infertility patients. Data will be transcribed verbatim and analysed via thematic analysis (Braun \& Clarke framework) assisted by NVivo 15.
Time frame: At the completion of the 6-month intervention
To explore the challenges and barriers faced by the healthcare providers who provide counselling-personalized care integrated intervention to the studied patients.Focuse onGynecologists, counselors and therapists.
Phase 2 qualitative study. Phenomenological in-depth semi-structured interviews will be conducted among PCOS-induced infertility patients. Data will be transcribed verbatim and analysed via thematic analysis (Braun \& Clarke framework) assisted by NVivo 15.
Time frame: At the completion of the 6-month intervention
Themes of challenges and barriers from focus group discussions among healthcare providers
Phase 2 qualitative study. Focus group discussions will be performed among healthcare providers delivering counselling-personalized care integrated intervention. Data will be transcribed verbatim and analysed via thematic analysis (Braun \& Clarke framework) assisted by NVivo 15.
Time frame: At the completion of the 6-month intervention
Plan to share: Undecided — This study will NOT share individual participant data (IPD). The dataset contains sensitive reproductive, medical and psychological information from women with PCOS-related infertility. Restriction of IPD sharing is approved by JEPeM-USM ethics committee and consistent with the Declaration of Helsinki, GCP, local privacy regulations and the signed informed consent. The study protocol does not include an IPD-sharing plan to prevent unauthorised access and misuse of participants' sensitive health information. Aggregated study results will be presented in publications.
Ran from May 2025 to primary completion in May 2026, 11 months.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 11 months is below that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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