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| Name | Class |
|---|---|
| Ren Ji Hospital of Shanghai Jiao Tong University | UNKNOWN |
| Women's Hospital of Zhejiang University | UNKNOWN |
| Shengjing Hospital | OTHER |
| Nanjing Medical University |
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To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.
To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes and to determine whether either starting metformin pretreatment before ovarian stimulation (aiming at improving the quality of oocyte/embryo) or starting before frozen embryo transfer (FET) (aiming at improving the receptivity of endometrium) could increase the chance of a healthy live birth compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin-Metformin Group | Experimental | Metformin pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by metformin pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer. |
|
| Metformin-Placebo Group | Experimental | Metformin pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by placebo pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer. |
|
| Placebo-Metformin Group | Experimental | Placebo pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by metformin pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer. |
|
| Placebo-Placebo Group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin pretreatment before ovarian stimulation | Drug | The enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval. |
| Measure | Description | Time Frame |
|---|---|---|
| healthy live birth | defined as a singleton live birth at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly. | From the date of randomization until delivery after the first embryo transfer, up to 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMI | change in body mass index (BMI) from baseline to the establishment of clinical pregnancy. | From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks |
| Change in fasting glucose level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi-Jiang Chen, Professor | Contact | +0086 531 85651190 | chenzijiang@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zi-Jiang Chen, Professor | Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong University | Recruiting | Jinan | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31574092 | Background | Wei Y, Xu Q, Yang H, Yang Y, Wang L, Chen H, Anderson C, Liu X, Song G, Li Q, Wang Q, Shen H, Zhang Y, Yan D, Peng Z, He Y, Wang Y, Zhang Y, Zhang H, Ma X. Preconception diabetes mellitus and adverse pregnancy outcomes in over 6.4 million women: A population-based cohort study in China. PLoS Med. 2019 Oct 1;16(10):e1002926. doi: 10.1371/journal.pmed.1002926. eCollection 2019 Oct. | |
| 16782722 |
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Deidentified participant data
6 months after publication
The data of this study are available on request from the corresponding author
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| OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| West China Second University Hospital | OTHER |
| Henan Provincial Maternal and Child Health Care Hospital | OTHER |
| Qingdao women's and children's Hospital | UNKNOWN |
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Placebo pretreatment before ovarian stimulation till oocyte retrieval and cryopreservation of all embryos, and followed by placebo pretreatment before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer. |
|
|
| Placebo pretreatment before ovarian stimulation | Drug | The enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks prior to ovarian stimulation till oocyte retrieval. |
|
|
| Metformin pretreatment before endometrial preparation for frozen embryo transfer | Drug | After oocyte retrieval, the enrolled patients will be prescribed metformin 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer. |
|
|
| Placebo pretreatment before endometrial preparation for frozen embryo transfer | Drug | After oocyte retrieval, the enrolled patients will be prescribed placebo 850mg twice daily for at least 4 weeks before endometrial preparation for frozen embryo transfer and till the establishment of clinical pregnancy (7-8 weeks gestation) after the first frozen embryo transfer. |
|
|
change in fasting glucose level from baseline to the establishment of clinical pregnancy. |
| From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks |
| Change in fasting insulin level | change in fasting insulin level from baseline to the establishment of clinical pregnancy. | From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks |
| Change in 2-h levels of glucose after 75-g OGTT | change in 2-h levels of glucose after 75-g OGTT from baseline to the establishment of clinical pregnancy. | From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks |
| Change in 2-h levels of insulin after 75-g OGTT | change in 2-h levels of insulin after 75-g OGTT from baseline to the establishment of clinical pregnancy. | From the date of randomization until the establishment of clinical pregnancy after the first embryo transfer, up to 26 weeks |
| Days of ovarian stimulation | the duration of ovarian stimulation by exogenous gonadotropin | From the date of randomization until the day of oocyte retrieved, up to 12 weeks |
| Total dose of gonadotropins | the total dose of exogenous gonadotropin used during ovarian stimulation | From the date of randomization until the day of oocyte retrieved, up to 12 weeks |
| Peak estradiol level | the estradiol level on the day of hCG trigger | From the date of randomization until the day of oocyte retrieved, up to 12 weeks |
| Number of oocyte retrieved | the number of oocyte retrieved | From the date of randomization until the day of oocyte retrieved, up to 12 weeks |
| Number of good-score embryos | the number of good-score embryos | From the date of randomization until the third day after oocyte retrieval, up to 12 weeks |
| Number of euploid embryos | the number of euploid embryos | From the date of randomization until the initiation of endometrial preparation for frozen embryo transfer, up to 20 weeks |
| OHSS | ovarian hyperstimulation syndrome was defined according to the Golan criteria | From the day of oocyte retrieved until the initiation of endometrial preparation for the first frozen embryo transfer, up to 8 weeks |
| Clinical pregnancy | defined as the ultrasound confirmation of at least one intrauterine gestational sac | 30-35 days after the first frozen embryo transfer |
| Singleton or twin pregnancy | the number of intrauterine gestational sacs | 30-35 days after the first frozen embryo transfer |
| Pregnancy loss | defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy. | From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months |
| Live birth | defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation | From the date of randomization until delivery after the first embryo transfer, up to 16 months |
| Incidences of obstetric and neonatal complications | including gestational diabetes mellitus, pre-eclampsia, premature rupture of membrane, placenta previa, placental abruption, congenital anomalies, postpartum hemorrhage, stillbirth, neonatal respiratory distress syndrome, neonatal jaundice, neonatal infection, neonatal death. | From the establishment of clinically recognized pregnancy until six weeks after delivery after the first embryo transfer, up to 11 months |
| Gestational weight gain | maternal weight gain during pregnancy | at delivery |
| Birth weight | birth weight of the newborn at delivery | at delivery |
| LGA | defined as the birthweight above the 90th percentile for gestational age based on a sex-specific reference | at delivery |
| SGA | defined as the birthweight below the 10th percentile for gestational age based on a sex-specific reference | at delivery |
| LBW | the infant born weighing less than 2500g | at delivery |
| Macrosomia | the infant born weighing larger than 4000g | at delivery |
| Adverse events | adverse event (AE) and serious adverse event (SAE) | From the date of randomization until six weeks after delivery after the first embryo transfer, up to 18 months |
| Cumulative live birth | define as women achieving live birth after all the cycles of embryo transfer per oocyte retrieval that performed within one year after randomization. | From the date of randomization until delivery, up to 28 months |
| Background |
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| 32556707 | Background | Huang J, Lin J, Lu X, Cai R, Song N, Kuang Y. Delayed versus immediate frozen embryo transfer after oocyte retrieval: a systematic review and meta-analysis. J Assist Reprod Genet. 2020 Aug;37(8):1949-1957. doi: 10.1007/s10815-020-01857-9. Epub 2020 Jun 19. |
| 34506996 | Background | Yildiz S, Turkgeldi E, Kalafat E, Keles I, Gokyer D, Ata B. Do live birth rate and obstetric outcomes vary between immediate and delayed embryo transfers following freeze-all cycles? J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102224. doi: 10.1016/j.jogoh.2021.102224. Epub 2021 Sep 8. |
| 27986819 | Background | Lattes K, Checa MA, Vassena R, Brassesco M, Vernaeve V. There is no evidence that the time from egg retrieval to embryo transfer affects live birth rates in a freeze-all strategy. Hum Reprod. 2017 Feb;32(2):368-374. doi: 10.1093/humrep/dew306. Epub 2016 Dec 16. |
| 26806686 | Background | Santos-Ribeiro S, Siffain J, Polyzos NP, van de Vijver A, van Landuyt L, Stoop D, Tournaye H, Blockeel C. To delay or not to delay a frozen embryo transfer after a failed fresh embryo transfer attempt? Fertil Steril. 2016 May;105(5):1202-1207.e1. doi: 10.1016/j.fertnstert.2015.12.140. Epub 2016 Jan 21. |
| 27609984 | Background | Santos-Ribeiro S, Polyzos NP, Lan VT, Siffain J, Mackens S, Van Landuyt L, Tournaye H, Blockeel C. The effect of an immediate frozen embryo transfer following a freeze-all protocol: a retrospective analysis from two centres. Hum Reprod. 2016 Nov;31(11):2541-2548. doi: 10.1093/humrep/dew194. Epub 2016 Sep 8. |
| 34461950 | Background | Song JY, Dong FY, Li L, Zhang XX, Wang AJ, Zhang Y, Gao DD, Xiao JM, Sun ZG. Immediate versus delayed frozen embryo transfer in women following a failed IVF-ET attempt: a multicenter randomized controlled trial. Reprod Biol Endocrinol. 2021 Aug 30;19(1):131. doi: 10.1186/s12958-021-00819-9. |
| 33885131 | Background | Li H, Sun X, Yang J, Li L, Zhang W, Lu X, Chen J, Chen H, Yu M, Fu W, Peng X, Chen J, Ng EHY. Immediate versus delayed frozen embryo transfer in patients following a stimulated IVF cycle: a randomised controlled trial. Hum Reprod. 2021 Jun 18;36(7):1832-1840. doi: 10.1093/humrep/deab071. |
| 34330423 | Background | Practice Committee of the American Society for Reproductive Medicine and the Practice Committee for the Society for Assisted Reproductive Technologies. Electronic address: ASRM@asrm.org. Guidance on the limits to the number of embryos to transfer: a committee opinion. Fertil Steril. 2021 Sep;116(3):651-654. doi: 10.1016/j.fertnstert.2021.06.050. Epub 2021 Jul 28. |
| 28583140 | Background | Wei D, Sun Y, Liu J, Liang X, Zhu Y, Shi Y, Chen ZJ. Live birth after fresh versus frozen single blastocyst transfer (Frefro-blastocyst): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):253. doi: 10.1186/s13063-017-1993-5. |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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