Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07409792
Eligibility Criteria:
1.Diagnostic Criteria for Infertility
The diagnosis is established in accordance with \*Obstetrics and Gynecology (10th Edition)\* and the \*Guidelines for Diagnosis and Treatment of Infertility (2019)\*. To be eligible, patients must meet the following criteria:
1. Be a woman of reproductive age, between 20 and 45 years old;
2. Have failed to achieve a clinical pregnancy after ≥12 months of regular, unprotected intercourse (or ≥6 months for women aged ≥35).
Furthermore, the indication for IVF-ET must be met by satisfying at least one of the following conditions:
1. Ovulatory factor infertility (e.g., hypothalamic amenorrhea or menstrual disorders, pituitary amenorrhea or menstrual disorders, ovarian amenorrhea or menstrual disorders, other endocrine disorders);
2. Pelvic factor infertility (e.g., congenital anomalies of the reproductive system, cervical factors, uterine disorders, tubal and/or peritoneal factors, endometriosis);
3. Male factor infertility (e.g., azoospermia, oligospermia, asthenospermia, teratospermia, isolated abnormal seminal plasma);
4. Unexplained infertility.
2\. Diagnostic Criteria for Anxiety State
Diagnosis is based on the diagnostic criteria for anxiety disorders as outlined in the \*Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\* and the \*International Classification of Diseases, Eleventh Revision (ICD-11)\*. Eligible patients must meet the following criteria:
1. Score ≥5 on the self-administered Generalized Anxiety Disorder 7-item (GAD-7) scale;
2. Exhibit significant anxiety symptoms: excessive worry not confined to specific circumstances, or disproportionate worry about various aspects of life;
3. Experience associated symptoms, such as: muscle tension or restlessness; symptoms of autonomic hyperactivity (e.g., frequent gastrointestinal symptoms like nausea or abdominal discomfort, palpitations, sweating, trembling, dry mouth); subjective feelings of tension, restlessness, difficulty concentrating, or irritability;
4. Symptoms persist for at least one month and are present most of the time;
5. The symptoms are not better explained by another mental disorder, are not attributable to the physiological effects of a substance or medication (or its withdrawal), and are not a manifestation of another medical condition;
6. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
3 Diagnostic Criteria for Insomnia Disorder Diagnosis is based on the diagnostic criteria for insomnia disorder as outlined in the \*Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the International Classification of Diseases, Eleventh Revision (ICD-11) 3. Eligible patients must meet the following criteria:
1. Score ≥8 on the self-administered Pittsburgh Sleep Quality Index (PSQI);
2. Report dissatisfaction with sleep quantity or quality, accompanied by one or more of the following symptoms: ① Difficulty initiating sleep (sleep latency \>30 minutes); ② Difficulty maintaining sleep, characterized by frequent awakenings or difficulty returning to sleep after awakenings (wake after sleep onset \>30 minutes); ③ Early morning awakening (waking \>30 minutes earlier than desired) with inability to return to sleep;
3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning;
4. The sleep difficulty occurs at least three nights per week and has been present for at least one month;
5. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder, mental disorder, or medical condition, and is not attributable to the physiological effects of a substance.
Inclusion Criteria:
* (1) Patients who meet the above diagnostic criteria and have undergone IVF-ET; (2) Female patients aged 20-45 years, with a BMI of 18-28 kg/m²; (3)The embryo to be transferred is a high-quality frozen-thawed embryo (either a Day-3 embryo with ≥8 cells, uniform blastomere size, and fragmentation rate \<10%, or a blastocyst with a grade of ≥3BB); (4) Willing to provide written informed consent and comply with luteal support therapy and follow-up.
Exclusion Criteria:
* (1) Unauthorized use of sedatives or anxiolytics during the treatment period; (2) Adherence to auricular point sticking therapy less than 80% (based on patient diary records); (3) Cancellation of the frozen embryo transfer cycle (e.g., due to endometrial transformation failure or sudden onset of ovarian hyperstimulation syndrome); (4) The participant voluntarily requests to withdraw from the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT07409792
Study Brief:
Protocol Section:
NCT07409792