A Phase 1 interventional study of human chorionic gonadotropin in Premature Ovarian Insufficiency, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Not yet recruiting. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Phase 1, Interventional, and Treatment
This project aims to activate dormant follicles in patients with premature ovarian insufficiency by injecting human chorionic gonadotropin (hCG) to explore the feasibility of a treatment plan that stimulates the growth of dormant follicles, not visible to the naked eye, to antral follicles visible under ultrasound, without visible follicle growth. The project also seeks to enable patients to conceive offspring carrying their own genetic material through in vitro fertilization (IVF) technology.
Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
The HCG group received a single intramuscular injection of 10,000 units of HCG. One to two weeks after the injection, transvaginal ultrasound was performed to observe follicular growth, with a monitoring period of 3 months (based on the fact that it takes humans 85 days to develop from a secondary follicle to a mature follicle). If no follicular growth was observed within 3 months, the observation was abandoned. If follicular growth was observed, gonadotropins were used or not used based on follicular development to promote growth or antagonists were used to prevent premature follicular release. When the follicle reached ≥18mm and estradiol reached ≥150pg/ml, recombinant human chorionic gonadotropin (rhCG) 250ug and triptorelin 0.1mg were co-administered to trigger ovulation. Oocyte retrieval was performed 36 hours after triggering. If embryos were obtained, they were cryopreserved for later frozen-thawed embryo transfer (FET) assistance in conception.
The control group underwent transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months. If no follicular growth was observed within 3 months, the observation was abandoned. If follicular growth was observed, gonadotropins were used or not used based on follicular development to promote growth or antagonists were used to prevent premature follicular release. When the follicle reached ≥18mm and estradiol reached ≥150pg/ml, rhCG 250ug and triptorelin 0.1mg were co-administered to trigger ovulation. Oocyte retrieval was performed 36 hours after triggering. If embryos were obtained, they were cryopreserved for later FET assistance in conception.
Follow-up Plan: ① Within 3 months after HCG administration, patients return to the center every 1-2 weeks for ultrasound and hormone testing, and return to the hospital promptly if any discomfort occurs during this period. ② After embryo transfer and pregnancy, follow-up on the outcome of childbirth, and follow-up on the offspring until one year after birth.
Exclusion Criteria:
The POl patients undergo transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months.
Embryo vitrification and freezing were performed after fertilization of oocytes.
Drug: human chorionic gonadotropin
The POI patients receive a single intramuscular injection of 10,000 units of human chorionic gonadotropin.
Also known as: HCG
focilles
Bilateral ovarian follicles were monitored by ultrasound
Time frame: Interval of 1-2 weeks after HCG injection
sex hormone
chemiluminescence method
Time frame: Interval of 1-2 weeks after HCG injection
Oocyte
Stereo microscope
Time frame: After the egg retrieval operation, the eggs are picked up and observed
Embryo
Stereo microscope
Time frame: 3-5 days after In vitro fertilization
Pregnancy outcome
Ultrasonic
Time frame: One month after embryo transfer
The health of the offspring
Telephone follow-up
Time frame: One year after birth
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine