Human Chorionic Gonadotropin
DrugThe POI patients receive a single intramuscular injection of 10,000 units of human chorionic gonadotropin.
Other names: HCG
NCT Number: NCT06754332
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.
Trial opening soon.
Get Notified20 year–39 year
Female
Interventional
Phase 1
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The POI patients receive a single intramuscular injection of 10,000 units of human chorionic gonadotropin.
Other names: HCG
Time frame: Interval of 1-2 weeks after HCG injection
Bilateral ovarian follicles were monitored by ultrasound
Time frame: Interval of 1-2 weeks after HCG injection
chemiluminescence method
Time frame: After the egg retrieval operation, the eggs are picked up and observed
Stereo microscope
Time frame: 3-5 days after In vitro fertilization
Stereo microscope
Time frame: One month after embryo transfer
Ultrasonic
Time frame: One year after birth
Telephone follow-up
Contact information is provided by the study sponsor or research team.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Other
The Research on the Role of Human Chorionic Gonadotropin (HCG) Activation in Vivo on the Dormant Follicles in Patients With Premature Ovarian Insufficiency (POI).
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