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To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.
This will be a multi-center double-blind randomized controlled trial, which aims to explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.The target population will be infertile women aged between 35 and 42 years, BMI<28kg/m2 and bilateral ovaries who undergo IVF-ET (long or antagonist protocol). Qualified 1,466 patients are randomized into either of two groups.They will be randomized to receive either Zishen Yutai Pill or the placebo. The pregnancy test results and pregnancy complications will be followed up by checking medical records and telephone calls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zishen Yutai pill group | Experimental | Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
|
| Placebo group | Placebo Comparator | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zishen Yutai Pill | Drug | Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Rate | Live birth rate=Number of live birth / Paticipants randomized | 1 year after embryo transfer day, up to a maximum duration of 58 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Retrieved Oocytes | The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration. | On embryo transfer day, approximately 6 weeks |
| Rate of Retrieved Oocytes | Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles with a diameter ≥10mm on the HCG injection day. |
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Inclusion Criteria:
Exclusion Criteria:
Exit Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongzi Yang, professor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Health Center For Women and Children | Chongqing | Chongqing Municipality | China | |||
| The First Hospital of Lanzhou University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41444477 | Derived | Li Y, Gong F, Wang X, Hu L, Li H, Guan Y, Ye H, Fan L, Bai H, Wang Z, Huang W, Ma X, Yang D, Zhang H. Zishen Yutai Pill increased live births in advanced maternal age women: a randomized clinical trial. Nat Commun. 2025 Dec 24;17(1):980. doi: 10.1038/s41467-025-67714-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zishen Yutai Pill Group | Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Zishen Yutai Pill: Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| FG001 | Placebo Group | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Placebo: Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zishen Yutai Pill Group | Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Zishen Yutai Pill: Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Live Birth Rate | Live birth rate=Number of live birth / Paticipants randomized | ITT population | Posted | Count of Participants | Participants | 1 year after embryo transfer day, up to a maximum duration of 58 weeks |
|
From enrollment until 1 year after ET, up to 58 weeks
maternal and neonatal adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zishen Yutai Pill Group | Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Zishen Yutai Pill: Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Endocrine disorders | MedDRA 27.1 | Systematic Assessment | Moderate to severe ovarian hyperstimulation syndrome |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dongzi Yang | Center for Reproductive Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 8602081332233 | yangdz@mail.sysu.edu.cn |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2019 | Feb 11, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000615671 | Zishen Yutai |
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|
| Placebo | Drug | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
|
| On embryo transfer day, approximately 6 weeks |
| Number of Matured Oocytes Retrieved | The number of oocytes with pronuclei or polar bodies observed on Day 1 after oocyte retrieval in IVF patients, or as the number of MII oocytes on the day of oocyte retrieval in ICSI patients. | On embryo transfer day, approximately 6 weeks |
| Rate of Matured Oocytes | Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes | On embryo transfer day, approximately 6 weeks |
| Number of Cleavage | Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval. | On embryo transfer day, approximately 6 weeks |
| Cleavage Rate | Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN) | On embryo transfer day, approximately 6 weeks |
| Number of Available Embryos | The sum of the number of embryos transferred and the number of embryos frozen. | On embryo transfer day, approximately 6 weeks |
| Rate of Available Embryos | Rate of available embryos=Number of available embryos/Number of cleaved oocytes. | On embryo transfer day, approximately 6 weeks |
| Number of High-quality Embryos | High-quality embryo will be defined according to the day of embryo transfer, following the Istanbul consensus and Gardner criteria, Day 2: 4 cells, cell fragments <10% and no multi-nucleus; Day 3: 8 cells, cell fragments <10%, no multi-nucleus; Day 5: stage 4 blastocyst, grade A inner cell mass, grade A trophectoderm (12,13). | On embryo transfer day, approximately 6 weeks |
| Rate of High-quality Embryos | Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos | On embryo transfer day, approximately 6 weeks |
| Biochemical Pregnancy Rate | Biochemical pregnancy rate=Number of positive pregnancy tests/Paticipants randomized | 14 days after ET day, approximately 8 weeks |
| Implantation Rate | Implantation rate=Number of gestational sacs/Number of embryos transferred | five weeks after ET day, approximately 11 weeks |
| Clinical Pregnancy Rate | The clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancies / Paticipants randomized | five weeks after ET day, approximately 11 weeks |
| Miscarriage Rate (Among Positive Pregnancy Test Population) | Miscarriage Rate (among positive pregnancy test population) =Number of miscarriages / Number of biochemical pregnancy | 1 year after embryo transfer, up to 58 weeks |
| Miscarriage Rate (Among Clinical Pregnancy Population) | Miscarriage rate (among clinical pregnancy population)=Number of miscarriages / Number of clinical pregnancies | 1 year after embryo transfer, up to 58 weeks |
| The Birth Weight of the Newborn | By checking medical records | 1 year after embryo transfer, up to 58 weeks |
| The Birth Height of the Newborn | By checking medical records | 1 year after embryo transfer, up to 58 weeks |
| Preterm Delivery Among Live Birth | Delivery of a fetus at less than 37 and more than 28 weeks gestational age. | 1 year after embryo transfer, up to 58 weeks |
| Low Birth Weight Among Neonates | Neonatal birth weight ≤ 2500 g. | 1 year after embryo transfer, up to 58 weeks |
| Congenital Anomalies Among Neonates | Congenital anomalies are defined as structural or functional anomalies that occur during intrauterine life, including minor and major anomalies. | 1 year after embryo transfer, up to 58 weeks |
| Neonates Entering NICU | NICU, neonate intensive care unit. | 1 year after embryo transfer, up to 58 weeks |
| Lanzhou |
| Gansu |
| China |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510000 | China |
| Liuzhou Maternal and Child Healthcare Hospital | Liuzhou | Guangxi | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| The Third Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Reproductive and Genetic Hospital of CITIC-XIANGYA | Changsha | Hunan | 410000 | China |
| The Affiliated Suzhou Hospital of Nanjing Medical University | Suzhou | Jiangsu | China |
| Reproductive Hospital affiliated to Shandong University | Jinan | Shandong | China |
| Northwest Women and Children's Hospital | Xi’an | Shanxi | China |
| Tangdu Hospital of Air Force Medical University | Xi’an | Shanxi | China |
| West China Second University Hospital/West China Women's and Children's Hospital | Sichuan | Sichuan | China |
| BG001 | Placebo Group | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Placebo: Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| Height | Mean | Standard Deviation | centimeter |
|
| Type of infertility | Count of Participants | Participants |
|
| Duration of attempt to conceive | Median | Inter-Quartile Range | years |
|
| Concomitant infertility factors | Number | participants |
|
| Previous IVF cycle | Count of Participants | Participants |
|
| Previous miscarriage | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Antral follicular count (AFC) | Median | Inter-Quartile Range | Follicles |
|
| Anti-Müllerian hormone (AMH) | Median | Inter-Quartile Range | ng/mL |
|
| Estradiol (E2) | Median | Inter-Quartile Range | pmol/L |
|
| follicular-stimulating hormone (FSH) | Median | Inter-Quartile Range | IU/L |
|
| Luteinizing hormone (LH) | Median | Inter-Quartile Range | IU/L |
|
| Prolactin (PRL) | Median | Inter-Quartile Range | mIU/L |
|
| Testerone (T) | Median | Inter-Quartile Range | nmol/L |
|
| OG001 | Placebo Group | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Placebo: Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
|
|
|
| Secondary | Number of Retrieved Oocytes | The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration. | ITT population | Posted | Median | Inter-Quartile Range | oocytes | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Rate of Retrieved Oocytes | Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles with a diameter ≥10mm on the HCG injection day. | ITT population | Posted | Median | Inter-Quartile Range | percentage of retrieved oocytes | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Number of Matured Oocytes Retrieved | The number of oocytes with pronuclei or polar bodies observed on Day 1 after oocyte retrieval in IVF patients, or as the number of MII oocytes on the day of oocyte retrieval in ICSI patients. | ITT population | Posted | Median | Inter-Quartile Range | oocytes | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Rate of Matured Oocytes | Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes | ITT population | Posted | Median | Inter-Quartile Range | percentage of matured oocytes | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Number of Cleavage | Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval. | ITT population | Posted | Median | Inter-Quartile Range | oocytes | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Cleavage Rate | Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN) | ITT population | Posted | Median | Inter-Quartile Range | percentage of cleaved embryos | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Number of Available Embryos | The sum of the number of embryos transferred and the number of embryos frozen. | ITT population | Posted | Median | Inter-Quartile Range | embryos | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Rate of Available Embryos | Rate of available embryos=Number of available embryos/Number of cleaved oocytes. | ITT population | Posted | Median | Inter-Quartile Range | percentage of available embryos | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Number of High-quality Embryos | High-quality embryo will be defined according to the day of embryo transfer, following the Istanbul consensus and Gardner criteria, Day 2: 4 cells, cell fragments <10% and no multi-nucleus; Day 3: 8 cells, cell fragments <10%, no multi-nucleus; Day 5: stage 4 blastocyst, grade A inner cell mass, grade A trophectoderm (12,13). | ITT population | Posted | Median | Inter-Quartile Range | embryos | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Rate of High-quality Embryos | Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos | ITT population | Posted | Median | Inter-Quartile Range | percentage of high-quality embryos | On embryo transfer day, approximately 6 weeks |
|
|
|
|
| Secondary | Biochemical Pregnancy Rate | Biochemical pregnancy rate=Number of positive pregnancy tests/Paticipants randomized | ITT population | Posted | Count of Participants | Participants | 14 days after ET day, approximately 8 weeks |
|
|
|
|
| Secondary | Implantation Rate | Implantation rate=Number of gestational sacs/Number of embryos transferred | Number of embryos transferred | Posted | Count of Units | embryos | five weeks after ET day, approximately 11 weeks | embryos | embryos |
|
|
|
|
| Secondary | Clinical Pregnancy Rate | The clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancies / Paticipants randomized | ITT population | Posted | Count of Participants | Participants | five weeks after ET day, approximately 11 weeks |
|
|
|
|
| Secondary | Miscarriage Rate (Among Positive Pregnancy Test Population) | Miscarriage Rate (among positive pregnancy test population) =Number of miscarriages / Number of biochemical pregnancy | Population with serum β-HCG positive during pregnancy tests | Posted | Count of Participants | Participants | 1 year after embryo transfer, up to 58 weeks |
|
|
|
|
| Secondary | Miscarriage Rate (Among Clinical Pregnancy Population) | Miscarriage rate (among clinical pregnancy population)=Number of miscarriages / Number of clinical pregnancies | Population with intrauterine gestation sac with fetal motion under transvaginal ultrasonography | Posted | Count of Participants | Participants | 1 year after embryo transfer, up to 58 weeks |
|
|
|
|
| Secondary | The Birth Weight of the Newborn | By checking medical records | Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group) | Posted | Median | Inter-Quartile Range | gram | 1 year after embryo transfer, up to 58 weeks | Neonates | Neonates |
|
|
|
|
| Secondary | The Birth Height of the Newborn | By checking medical records | Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group) | Posted | Median | Inter-Quartile Range | centimeter | 1 year after embryo transfer, up to 58 weeks | Neonates | Neonates |
|
|
|
|
| Secondary | Preterm Delivery Among Live Birth | Delivery of a fetus at less than 37 and more than 28 weeks gestational age. | Participants who had live birth | Posted | Count of Participants | Participants | 1 year after embryo transfer, up to 58 weeks |
|
|
|
|
| Secondary | Low Birth Weight Among Neonates | Neonatal birth weight ≤ 2500 g. | Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group) | Posted | Count of Units | Neonates | 1 year after embryo transfer, up to 58 weeks | Neonates | Neonates |
|
|
|
|
| Secondary | Congenital Anomalies Among Neonates | Congenital anomalies are defined as structural or functional anomalies that occur during intrauterine life, including minor and major anomalies. | Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group) | Posted | Count of Units | neonates | 1 year after embryo transfer, up to 58 weeks | neonates | neonates |
|
|
|
|
| Secondary | Neonates Entering NICU | NICU, neonate intensive care unit. | Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group) | Posted | Count of Units | neonates | 1 year after embryo transfer, up to 58 weeks | neonates | neonates |
|
|
|
|
| 0 |
| 734 |
| 22 |
| 734 |
| 0 |
| 734 |
| EG001 | Placebo Group | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Placebo: Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. | 0 | 733 | 18 | 733 | 0 | 733 |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment | Hospitalization due to miscarriage |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 27.1 | Systematic Assessment |
|
| Cryptorchidism | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment | Neonatal congenital cryptorchidism |
|
| Appendectomy | Surgical and medical procedures | MedDRA 27.1 | Systematic Assessment |
|
| Congenital atrial septal defect | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
| D000091662 | Genital Diseases |
|
| Twin |
|
|
| 0.417 |
| Other |
|
| Twin |
|
|
| 0.157 |
| Other |