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Clinical trial of nicotinamide combined with estrogen and progesterone on primary ovarian insufficiency

Clinical trial of nicotinamide combined with estrogen and progesterone on primary ovarian insufficiency

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035390
Enrollment
Unknown
Registered
2020-08-09
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

primary ovarian insufficiency

Interventions

The control group:estrogen-progesterone replacement
Experimental group 1:nicotinamide
Experimental group 2:estrogen-progesterone replacement combined with nicotinamide

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Under 40 years of age; 2. Have established regular menstrual cycle, oligomenorrhea / amenorrhea >=4 months; 3. FSH (Follicle-Stimulating Hormone) > 25 IU/mL; 4. Subclinical stage of POI, FSH level is 15-25U/L.

Exclusion criteria

Exclusion criteria: 1. Secondary ovarian insufficiency (e.g.hypothalamic cause); 2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome); 3. History of previous malignant or ovarian tumors, history of ovarian therapy; 4. Polycystic ovarian syndrome; 5. Congenital uterine anomalies; 6. Severe endometriosis; 7. Autoimmune disease, history of severe familial genetic disease, etc; 8. HIV+, hepatitis B, C; 9. History of serious drug allergy or allergic constitution; 10. Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease.

Design outcomes

Primary

MeasureTime frame
Follicle-stimulating hormone;

Secondary

MeasureTime frame
Pregnancy rate;Anti-Mullerian Hormone (AMH) serum level;Number of Antral follicle development;Estradiol (E2) serum level;Ovarian volume;Luteinizing hormone;

Countries

China

Contacts

Public ContactShaohua Xu

Shanghai First Maternity and Infant Hospital

xushaohua@tongji.edu.cn+86 021-20261066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026