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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: â‘ 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. â‘¡ After embryo transfer and pregnancy, follow-up on the outcome of childbirth, and follow-up on the offspring until one year after birth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expectant treatment | No Intervention | The POl patients undergo transvaginal ultrasound to observe follicular growth every 1-2 weeks, with a monitoring period of 3 months. | |
| In vitro fertilization - Embryo transfer | Other | Embryo vitrification and freezing were performed after fertilization of oocytes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human chorionic gonadotropin | Drug | The POI patients receive a single intramuscular injection of 10,000 units of human chorionic gonadotropin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| focilles | Bilateral ovarian follicles were monitored by ultrasound | Interval of 1-2 weeks after HCG injection |
| Measure | Description | Time Frame |
|---|---|---|
| sex hormone | chemiluminescence method | Interval of 1-2 weeks after HCG injection |
| Oocyte | Stereo microscope | After the egg retrieval operation, the eggs are picked up and observed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Chen, Master | Contact | 13868903230 | 30395478@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Chen, Master | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36229897 | Result | Xiao Y, Peng X, Peng Y, Zhang C, Liu W, Yang W, Dou X, Jiang Y, Wang Y, Yang S, Xiang W, Wu T, Li J. Macrophage-derived extracellular vesicles regulate follicular activation and improve ovarian function in old mice by modulating local environment. Clin Transl Med. 2022 Oct;12(10):e1071. doi: 10.1002/ctm2.1071. | |
| 9683349 | Result |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| Embryo | Stereo microscope | 3-5 days after In vitro fertilization |
| Pregnancy outcome | Ultrasonic | One month after embryo transfer |
| The health of the offspring | Telephone follow-up | One year after birth |
| Cha KY, Chian RC. Maturation in vitro of immature human oocytes for clinical use. Hum Reprod Update. 1998 Mar-Apr;4(2):103-20. doi: 10.1093/humupd/4.2.103. |
| 37441160 | Result | Chian RC, Li JH, Lim JH, Yoshida H. IVM of human immature oocytes for infertility treatment and fertility preservation. Reprod Med Biol. 2023 Jul 11;22(1):e12524. doi: 10.1002/rmb2.12524. eCollection 2023 Jan-Dec. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |