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Multicenter randomized controlled clinical study protocol for the treatment of ovarian reserve insufficiency in Jinfeng pills

Multicenter randomized controlled clinical study protocol for the treatment of ovarian reserve insufficiency in Jinfeng pills

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001068
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decline in ovarian reserve function

Interventions

Traditional Chinese medicine trial group:Jinfeng Pill + Fenmotone Analogue
control group:Fenmotone + Jinfeng Pill Mock

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Females aged 18-45 years (2) Meet the DOR diagnostic criteria (at least 2 of the following): 1) Basal FSH =10 < 25 IU/L for at least two menstrual cycles (day 2~4 of the menstrual cycle) 2)AMH <1.1 ng/mL 3) AFC (antral follicle count) < 5 (3) Traditional Chinese medicine syndrome differentiation is kidney essence deficiency syndrome (4) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) History of ovarian surgery, radiotherapy or chemotherapy, or known chromosomal abnormalities (such as Turner syndrome). 2) Patients with severe underlying medical conditions (such as liver or kidney dysfunction, a history of thrombosis, breast cancer, or other contraindications to HRT). 3) Those who have taken hormonal medications or drugs that affect ovarian function within the past 3 months, except dydrogesterone tablets. 4) Pregnant or breastfeeding women. 5) Individuals who are allergic to the components of the study drug. 6) Patients who are also taking other medications intended to enhance ovarian reserve function, such as vitamin E or coenzyme Q10. 7) Patients with intellectual disabilities or mental health conditions. 8) Individuals who have other contraindications to the use of estrogen or who, in the judgment of the study investigators, are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Follicle-stimulating hormone (Days 2 to 5 of the menstrual cycle);

Secondary

MeasureTime frame
anti-Müllerian hormone;antral follicle count((Days 2 to 5 of menstruation));Follicle-stimulating hormone/luteinizing hormone(Days 2 to 5 of menstruation);Estradiol;Volume of both ovaries;ovulation rate;pregnancy rate;Traditional Chinese Medicine syndrome scoring system;Kupperman score;Anxiety and Depression Scale;Menopause-Specific Quality of Life Questionnaire;

Countries

China

Contacts

Public ContactCAO Qi

Obstetrics & Gynecology Hospital of Fudan University

qicao@fudan.edu.cn13918168038

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026