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Laparoscopic Ovarian Cortical Intracorporeal Activation Technology for the Treatment of Premature Ovarian Insufficiency (POI)/Premature Ovarian Failure (POF): A Multicenter Clinical Trial

Laparoscopic Ovarian Cortical Intracorporeal Activation Technology for the Treatment of Premature Ovarian Insufficiency (POI)/Premature Ovarian Failure (POF): A Multicenter Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038459
Enrollment
Unknown
Registered
2020-09-23
Start date
2020-12-09
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

premature ovarian insufficiency (POI)/ premature ovarian failure (POF)

Interventions

Intervention group:laparoscopic in vivo activation of ovarian cortex

Sponsors

Guangdong Second Provincial General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Premature ovarian failure (POF): (1) Less than 40 years old; (2) Primary or secondary amenorrhea > for 4 months; (3) FSH > 40IU/L at least once; (4) Accompanied by hot flashes, sweating, mood swings and other estrogen reduction symptoms of menopause; (5) Good function of heart, liver, kidney and blood coagulation, no history of internal and surgical diseases or malignant tumors; (6) The chromosomes are normal and there are no genetic diseases; (7) The patient and/her family members voluntarily participate in the trial and sign the informed consent form. They have fertility requirements and plan to perform Assisted Reproduction Technology. 2. Patients with premature ovarian insufficiency (POI): (1) Less than 40 years old; (2) The number of basic follicles in the ovarian was less than 4, and 25U/L<= FSH <= 40 IU/L, at least one test result (3) No oocytes were obtained in previous IVF cycles or no embryos were available although oocytes were obtained; (4) Good function of heart, liver, kidney and blood coagulation, no history of internal and surgical diseases or malignant tumors; (5) The chromosomes are normal and there are no genetic diseases; (6) The patient and her family members voluntarily participate in the trial and sign the informed consent form. They have fertility requirements and plan to perform Assisted Reproduction Technology.

Exclusion criteria

Exclusion criteria: 1. Definite chromosomal abnormalities or serious genetic diseases; 2. Contraindications to laparoscopic surgery; 3. Pregnant or nursing patients; 4. Participated in other clinical trials in the last 3 months; 5. Lack of legal capacity or limited legal capacity; 6. Any other conditions in which the investigator considers it is inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
clinical pregnancy rate;Cumulative live birth rate;Ovarian reserve function recovery rate (At any time point post-treatment, serum Anti-Müllerian Hormone (AMH) levels increase from baseline AND baseline Antral Follicle Count (AFC) increases by >= 1);

Secondary

MeasureTime frame
Perimenopausal symptom score;

Countries

China

Contacts

Public ContactOu Xianghong

Guangdong Second Provincial General Hospital

ouxianghong2003@163.com+86 139 2516 7065

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026