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InfertilityCPII-PCOS-INCT07906756

The Effectiveness of CPII for Infertility Induced by PCOS in China

A study testing Standard Treatment for PCOS-Induced Infertility, Personalized Care-Integrated Intervention (PII) and Integrated Counselling & Personalized Care for PCOS-Induced Infertility in people with Infertility and Poly Cystic Ovary Syndrome, run by Universiti Sains Malaysia at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Poly Cystic Ovary Syndrome
What is being tested?
Standard Treatment for PCOS-Induced Infertility, Personalized Care-Integrated Intervention (PII) and Integrated Counselling & Personalized Care for PCOS-Induced Infertility
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
4 sitesChina
Study dates
11 May 2025to 11 May 2026
Phase
Interventional
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women of reproductive age with PCOS-induced infertility in the four above-mentioned hospitals, with the following inclusion, exclusion, and withdrawal criteria:
  • Confirmed PCOS diagnosis by a physician per Rotterdam standards (antral follicle count (AFC) ≥12, or ovarian volume ≥10 ml; latest update raises AFC threshold to 20 follicles); significant metabolic risks include higher incidence of abnormal blood glucose and metabolic syndrome (Kim et al., 2020).
  • Documented infertility (failure to conceive after 12 months of regular attempts).
  • Aged 18-45 years (PCOS is most common in this group, where women are in a crucial pregnancy-planning stage with important physical and psychological development; extreme ages may cause greater fertility differences).

Who cannot join

  • Other infertility causes (fallopian tube obstruction, male factor infertility), severe comorbidities, or systemic diseases.
  • Severe or uncontrolled systemic diseases (cardiovascular, renal, liver diseases, or uncontrolled diabetes).
  • Gynecological conditions (endometriosis, untreated thyroid disorders, or significant hormonal imbalances).
  • Prior specific infertility treatments (e.g., in vitro fertilization (IVF), ovulation induction).
  • Obesity or underweight.
  • Simultaneous participation in other clinical trials/studies.
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  • Current pregnancy.
  • Severe psychiatric disorders or cognitive impairments.
  • Taking non-PCOS-related medications (hormonal treatments, hypoglycemic, antihypertensive, anti-anxiety, or antidepressant drugs).
  • Withdrawal Criteria:
  • Ineligibility or failure to meet criteria.
  • Non-compliance with treatment protocol.
  • Serious adverse effects or health risks.
  • Personal reasons or inability to continue.
  • Pregnancy.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The Gynecology Department , Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Reproductive Medicine Department, Jining Medical College Affiliated Hospital

    Jining, Shandong, 272000

  • Taibai Lake Hospital of the Affiliated Hospital ofJining Medical College

    Jining, Shandong, 272000

  • The Gynecology Department ,Tengzhou Central People's Hospital

    Tengzhou, Shandong, 277500

Other trials in China

About this study

Official title: The Effectiveness of Counselling and Personalized Care-Integrated Interventions for Infertility Induced by Polycystic Ovary Syndrome in China

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.

Read the detailed description

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:

  1. Patient Information Sheet and Consent Form (English version) - Phase 1
  2. Patient Information Sheet and Consent Form (Malay version) - Phase 1
  3. Patient Information Sheet and Consent Form (English version) - Phase 2
  4. Patient Information Sheet and Consent Form (Malay version) - Phase 2
  5. Participant Information Sheet and Consent Form (English version) - Phase 2
  6. Participant Information Sheet and Consent Form (Malay version) - Phase 2
  7. Case Report Form
  8. Scoring system for SAS
  9. Scoring system for SDS
  10. Scoring system for SRSS
  11. Scoring system for SWLS
  12. Scoring system for PSQ-18
  13. Interview outline for patients
  14. Interview outline for health care providers
Being tested
Standard Treatment for PCOS-Induced Infertility, Counselling-Integrated Standard Care for PCOS-Induced Infertility, Personalized Care-Integrated Intervention (PII), Integrated Counselling & Personalized Care for PCOS-Induced Infertility
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Treatment for PCOS-Induced InfertilityBehavioural

    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).

  • Counselling-Integrated Standard Care for PCOS-Induced InfertilityBehavioural

    Structured psychological counselling, stress management training and emotional support for infertile women with PCOS, delivered by trained reproductive nursing staff.

  • Personalized Care-Integrated Intervention (PII)Behavioural

    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 Counselling & Personalized Care for PCOS-Induced InfertilityBehavioural

    Integrated intervention combining structured psychological counselling and individualized personalized care, simultaneously addressing psychological distress and self-management of metabolic and reproductive health.

Study groups in NCT07906756
Study groupRoleWhat they receive
Standard Treatment Intervention (STI)Active comparatorParticipants 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.
Receives: Behavioral: Standard Treatment for PCOS-Induced Infertility
Counselling-Integrated Intervention Arm for PCOS-Induced InfertilityExperimentalThis 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.
Receives: Behavioral: Standard Treatment for PCOS-Induced Infertility; Behavioral: Counselling-Integrated Standard Care for PCOS-Induced Infertility
Personalized Care-Integrated Intervention (PII)ExperimentalParticipants receive the same standard treatment as the STI group plus individualized personalized care, including tailored diet plans, exercise prescription and regular follow-up.
Receives: Behavioral: Standard Treatment for PCOS-Induced Infertility; Behavioral: Personalized Care-Integrated Intervention (PII)
Counseling and personalized care-integrated intervention (CPII)ExperimentalParticipants receive the same standard treatment as the STI group, combined with both psychological counselling and individualized personalized care.
Receives: Behavioral: Standard Treatment for PCOS-Induced Infertility; Behavioral: Integrated Counselling & Personalized Care for PCOS-Induced Infertility

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after the start of intervention

  2. 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.

    Measured: 6 months after the start of intervention

  3. Serum testosterone level

    Serum testosterone level detected by standard biochemical laboratory assay.

    Measured: 6 months after the start of intervention

  4. Serum estradiol level

    Serum estradiol level detected by standard biochemical laboratory assay.

    Measured: 6 months after the start of intervention

  5. Serum progesterone level

    Serum progesterone level detected by standard biochemical laboratory assay.

    Measured: 6 months after the start of intervention

  6. Serum luteinizing hormone (LH) level

    Serum luteinizing hormone level detected by standard biochemical laboratory assay.

    Measured: 6 months after the start of intervention

  7. Serum follicle-stimulating hormone (FSH) level

    Serum follicle-stimulating hormone concentration detected by standard biochemical laboratory assay.

    Measured: 6 months after the start of intervention

  8. Body mass index (BMI)

    Body mass index (BMI, unit: kg/m²), calculated as weight in kilograms divided by height in meters squared.

    Measured: 6 months after the start of intervention

Secondary outcomes (5)

  1. 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.

    Measured: 6 months after the start of intervention

  2. 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.

    Measured: 6 months after the start of intervention

  3. 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.

    Measured: 6 months after the start of intervention

  4. 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.

    Measured: 6 months after the start of intervention

  5. 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.

    Measured: 6 months after the start of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start11 May 2025
  3. Primary completion10 May 2026
  4. Study completion11 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07906756
Sponsor's protocol ID
USM/JEPeM/KK/24100900
Other IDs
USM/JEPeM/KK/24100900
Acronym
CPII-PCOS-I
Status last verified
Oct 2026
First submitted
25 Feb 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Standard Treatment for PCOS-Induced Infertility, Personalized Care-Integrated Intervention (PII) and Integrated Counselling & Personalized Care for PCOS-Induced Infertility in people with Infertility and Poly Cystic Ovary Syndrome, run by Universiti Sains Malaysia at 4 sites in China.

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 4 inclusion and 15 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: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical pregnancy rate (time frame: 6 months after the start of intervention). The study lists 8 primary outcomes in all. 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 NCT07906756.

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 30 Oct 2026.

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