Trial · NCT07906756
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biochemical pregnancy rate | 6 months after the start of intervention | 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. |
| Primary | Menstrual cycle regularity | 6 months after the start of intervention | 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. |
| Primary | Serum testosterone level | 6 months after the start of intervention | Serum testosterone level detected by standard biochemical laboratory assay. |
| Primary | Serum estradiol level | 6 months after the start of intervention | Serum estradiol level detected by standard biochemical laboratory assay. |
| Primary | Serum progesterone level | 6 months after the start of intervention | Serum progesterone level detected by standard biochemical laboratory assay. |
| Primary | Serum luteinizing hormone (LH) level | 6 months after the start of intervention | Serum luteinizing hormone level detected by standard biochemical laboratory assay. |
| Primary | Serum follicle-stimulating hormone (FSH) level | 6 months after the start of intervention | Serum follicle-stimulating hormone concentration detected by standard biochemical laboratory assay. |
| Primary | Body mass index (BMI) | 6 months after the start of intervention | Body mass index (BMI, unit: kg/m²), calculated as weight in kilograms divided by height in meters squared. |
| Secondary | Anxiety score assessed by Self-Rating Anxiety Scale (SAS) | 6 months after the start of intervention | Anxiety is assessed by the validated Chinese version of the Self-Rating Anxiety Scale (SAS); higher scores indicate more severe anxiety symptoms. |
| Secondary | Depression score measured by Self-Rating Depression Scale (SDS) | 6 months after the start of intervention | Depression is assessed by the validated Chinese version of the Self-Rating Depression Scale (SDS); higher scores indicate more severe depressive symptoms. |
| Secondary | Sleep quality score measured by Self-Rating Scale of Sleep (SRSS) | 6 months after the start of intervention | 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. |
| Secondary | Life satisfaction score measured by Satisfaction with Life Scale (SWLS) | 6 months after the start of intervention | Subjective life satisfaction is evaluated using the validated Satisfaction with Life Scale (SWLS); higher scores reflect greater life satisfaction. |
| Secondary | Patient satisfaction score measured by Short-form Patient Satisfaction Questionnaire (PSQ-18) | 6 months after the start of intervention | Patient satisfaction is assessed using the Chinese adapted version of PSQ-18; higher scores represent higher satisfaction with healthcare services. |
| Other | To explore the challenges and barriers faced by the patients undergoing counselling personalized care integrated intervention. | At the completion of the 6-month 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. |
| Other | 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. | At the completion of the 6-month 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. |
| Other | Themes of challenges and barriers from focus group discussions among healthcare providers | At the completion of the 6-month intervention | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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