Infertility, Female
Conditions
Keywords
IVF-ET, infertility, aged, women
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* infertile women aged ≥35 and ≤42 years; * intend to undergo IVF/ICSI-ET (GnRH-a long protocol or GnRH-ant protocol); * BMI\<28kg/m2; * bilateral ovaries exist; * patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol.
Exclusion criteria
* repeated implantation failure (previous three times or more IVF/ICSI-ET failure); * adenomyosis, uterine line constricted by uterine fibroid; * untreated bilateral hydrosalpinx; * endometrial diseases that have not been cured ; * known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy; * patients who have taken traditional Chinese medicine or Chinese patent medicine for infertility treatment in the last month(30 days). Exit Criteria: * subjects who have adverse events cannot be tolerated; * severe breach of the protocol; * for subjects who exit due to personal or unpredictable reasons, please describe specific details; * subjects considered inappropriate to continue to participate in the study for other medical reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth Rate | 1 year after embryo transfer day, up to a maximum duration of 58 weeks | Live birth rate=Number of live birth / Paticipants randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Retrieved Oocytes | On embryo transfer day, approximately 6 weeks | Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles with a diameter ≥10mm on the HCG injection day. |
| Number of Matured Oocytes Retrieved | On embryo transfer day, approximately 6 weeks | 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. |
| Rate of Matured Oocytes | On embryo transfer day, approximately 6 weeks | Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes |
| Number of Cleavage | On embryo transfer day, approximately 6 weeks | Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval. |
| Cleavage Rate | On embryo transfer day, approximately 6 weeks | Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN) |
| Number of Available Embryos | On embryo transfer day, approximately 6 weeks | The sum of the number of embryos transferred and the number of embryos frozen. |
| Rate of Available Embryos | On embryo transfer day, approximately 6 weeks | Rate of available embryos=Number of available embryos/Number of cleaved oocytes. |
| Number of High-quality Embryos | On embryo transfer day, approximately 6 weeks | 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). |
| Rate of High-quality Embryos | On embryo transfer day, approximately 6 weeks | Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos |
| Biochemical Pregnancy Rate | 14 days after ET day, approximately 8 weeks | Biochemical pregnancy rate=Number of positive pregnancy tests/Paticipants randomized |
| Number of Retrieved Oocytes | On embryo transfer day, approximately 6 weeks | The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration. |
| Clinical Pregnancy Rate | five weeks after ET day, approximately 11 weeks | The clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancies / Paticipants randomized |
| Miscarriage Rate (Among Positive Pregnancy Test Population) | 1 year after embryo transfer, up to 58 weeks | Miscarriage Rate (among positive pregnancy test population) =Number of miscarriages / Number of biochemical pregnancy |
| Miscarriage Rate (Among Clinical Pregnancy Population) | 1 year after embryo transfer, up to 58 weeks | Miscarriage rate (among clinical pregnancy population)=Number of miscarriages / Number of clinical pregnancies |
| The Birth Weight of the Newborn | 1 year after embryo transfer, up to 58 weeks | By checking medical records |
| The Birth Height of the Newborn | 1 year after embryo transfer, up to 58 weeks | By checking medical records |
| Preterm Delivery Among Live Birth | 1 year after embryo transfer, up to 58 weeks | Delivery of a fetus at less than 37 and more than 28 weeks gestational age. |
| Low Birth Weight Among Neonates | 1 year after embryo transfer, up to 58 weeks | Neonatal birth weight ≤ 2500 g. |
| Congenital Anomalies Among Neonates | 1 year after embryo transfer, up to 58 weeks | Congenital anomalies are defined as structural or functional anomalies that occur during intrauterine life, including minor and major anomalies. |
| Neonates Entering NICU | 1 year after embryo transfer, up to 58 weeks | NICU, neonate intensive care unit. |
| Implantation Rate | five weeks after ET day, approximately 11 weeks | Implantation rate=Number of gestational sacs/Number of embryos transferred |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 734 |
| 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. | 733 |
| Total | 1,467 |
Baseline characteristics
| Characteristic | Zishen Yutai Pill Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 37.25 years STANDARD_DEVIATION 1.8 | 37.25 years STANDARD_DEVIATION 1.88 | 37.25 years STANDARD_DEVIATION 1.84 |
| Age, Customized Between 35 and 37 years | 425 Participants | 426 Participants | 851 Participants |
| Age, Customized Between 38 and 39 years | 213 Participants | 212 Participants | 425 Participants |
| Age, Customized Between 40 and 42 years | 96 Participants | 95 Participants | 191 Participants |
| Anti-Müllerian hormone (AMH) | 2.10 ng/mL | 2.06 ng/mL | 2.09 ng/mL |
| Antral follicular count (AFC) | 11 Follicles | 11 Follicles | 11 Follicles |
| BMI | 22.72 kg/m^2 STANDARD_DEVIATION 2.61 | 22.66 kg/m^2 STANDARD_DEVIATION 2.64 | 22.69 kg/m^2 STANDARD_DEVIATION 2.62 |
| Concomitant infertility factors Diabetes | 32 participants | 35 participants | 67 participants |
| Concomitant infertility factors Endometriosis | 22 participants | 13 participants | 35 participants |
| Concomitant infertility factors Male factors | 331 participants | 345 participants | 676 participants |
| Concomitant infertility factors Obese/overweight | 69 participants | 75 participants | 144 participants |
| Concomitant infertility factors Ovulation disorder | 78 participants | 96 participants | 174 participants |
| Concomitant infertility factors Pelvic factors and tubal factors | 519 participants | 542 participants | 1061 participants |
| Concomitant infertility factors Scar uterus | 88 participants | 93 participants | 181 participants |
| Concomitant infertility factors Unexplained factors | 35 participants | 25 participants | 60 participants |
| Duration of attempt to conceive | 3.0 years | 4.0 years | 4.0 years |
| Estradiol (E2) | 160.74 pmol/L | 159.61 pmol/L | 160.31 pmol/L |
| follicular-stimulating hormone (FSH) | 6.83 IU/L | 6.84 IU/L | 6.83 IU/L |
| Height | 159.40 centimeter STANDARD_DEVIATION 5.38 | 159.14 centimeter STANDARD_DEVIATION 5.26 | 159.27 centimeter STANDARD_DEVIATION 5.32 |
| Luteinizing hormone (LH) | 4.05 IU/L | 4.09 IU/L | 4.08 IU/L |
| Previous IVF cycle 0 | 604 Participants | 591 Participants | 1195 Participants |
| Previous IVF cycle 1 | 54 Participants | 71 Participants | 125 Participants |
| Previous IVF cycle 2 | 48 Participants | 49 Participants | 97 Participants |
| Previous IVF cycle ≥3 | 18 Participants | 12 Participants | 30 Participants |
| Previous IVF cycle Missing | 10 Participants | 10 Participants | 20 Participants |
| Previous miscarriage | 138 Participants | 148 Participants | 286 Participants |
| Prolactin (PRL) | 281.85 mIU/L | 283.66 mIU/L | 282.17 mIU/L |
| Race/Ethnicity, Customized Asian | 734 Participants | 733 Participants | 1467 Participants |
| Sex: Female, Male Female | 734 Participants | 733 Participants | 1467 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Testerone (T) | 0.90 nmol/L | 0.94 nmol/L | 0.90 nmol/L |
| Type of infertility Missing | 8 Participants | 8 Participants | 16 Participants |
| Type of infertility Primary infertility | 181 Participants | 171 Participants | 352 Participants |
| Type of infertility Secondary infertility | 545 Participants | 554 Participants | 1099 Participants |
| Weight | 57.79 kilogram STANDARD_DEVIATION 7.76 | 57.42 kilogram STANDARD_DEVIATION 7.51 | 57.61 kilogram STANDARD_DEVIATION 7.64 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 734 | 0 / 733 |
| other Total, other adverse events | 0 / 734 | 0 / 733 |
| serious Total, serious adverse events | 22 / 734 | 18 / 733 |
Outcome results
Primary
Live Birth Rate
Live birth rate=Number of live birth / Paticipants randomized
Time frame: 1 year after embryo transfer day, up to a maximum duration of 58 weeks
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zishen Yutai Pill Group | Live Birth Rate | 171 Participants |
| Placebo Group | Live Birth Rate | 139 Participants |
p-value: 0.04295% CI: [1.01, 1.5]Chi-squared
Secondary
Biochemical Pregnancy Rate
Biochemical pregnancy rate=Number of positive pregnancy tests/Paticipants randomized
Time frame: 14 days after ET day, approximately 8 weeks
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zishen Yutai Pill Group | Biochemical Pregnancy Rate | 232 Participants |
| Placebo Group | Biochemical Pregnancy Rate | 195 Participants |
p-value: 0.03595% CI: [1.01, 1.4]Chi-squared
Secondary
Cleavage Rate
Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN)
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Cleavage Rate | 91.0 percentage of cleaved embryos |
| Placebo Group | Cleavage Rate | 90.0 percentage of cleaved embryos |
p-value: 0.86Wilcoxon (Mann-Whitney)
Secondary
Clinical Pregnancy Rate
The clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancies / Paticipants randomized
Time frame: five weeks after ET day, approximately 11 weeks
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zishen Yutai Pill Group | Clinical Pregnancy Rate | 216 Participants |
| Placebo Group | Clinical Pregnancy Rate | 177 Participants |
p-value: 0.02295% CI: [1.03, 1.45]Chi-squared
Secondary
Congenital Anomalies Among Neonates
Congenital anomalies are defined as structural or functional anomalies that occur during intrauterine life, including minor and major anomalies.
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Zishen Yutai Pill Group | Congenital Anomalies Among Neonates | 1 neonates |
| Placebo Group | Congenital Anomalies Among Neonates | 2 neonates |
p-value: 0.5995% CI: [0.04, 4.45]Fisher Exact
Secondary
Implantation Rate
Implantation rate=Number of gestational sacs/Number of embryos transferred
Time frame: five weeks after ET day, approximately 11 weeks
Population: Number of embryos transferred
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Zishen Yutai Pill Group | Implantation Rate | 252 embryos |
| Placebo Group | Implantation Rate | 204 embryos |
p-value: 0.03495% CI: [1.01, 1.37]Chi-squared
Secondary
Low Birth Weight Among Neonates
Neonatal birth weight ≤ 2500 g.
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Zishen Yutai Pill Group | Low Birth Weight Among Neonates | 24 Neonates |
| Placebo Group | Low Birth Weight Among Neonates | 18 Neonates |
p-value: 0.76995% CI: [0.61, 1.94]Chi-squared
Secondary
Miscarriage Rate (Among Clinical Pregnancy Population)
Miscarriage rate (among clinical pregnancy population)=Number of miscarriages / Number of clinical pregnancies
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Population with intrauterine gestation sac with fetal motion under transvaginal ultrasonography
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zishen Yutai Pill Group | Miscarriage Rate (Among Clinical Pregnancy Population) | 45 Participants |
| Placebo Group | Miscarriage Rate (Among Clinical Pregnancy Population) | 38 Participants |
p-value: 0.87895% CI: [0.66, 1.42]Chi-squared
Secondary
Miscarriage Rate (Among Positive Pregnancy Test Population)
Miscarriage Rate (among positive pregnancy test population) =Number of miscarriages / Number of biochemical pregnancy
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Population with serum β-HCG positive during pregnancy tests
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zishen Yutai Pill Group | Miscarriage Rate (Among Positive Pregnancy Test Population) | 57 Participants |
| Placebo Group | Miscarriage Rate (Among Positive Pregnancy Test Population) | 51 Participants |
p-value: 0.70795% CI: [0.68, 1.3]Chi-squared
Secondary
Neonates Entering NICU
NICU, neonate intensive care unit.
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Zishen Yutai Pill Group | Neonates Entering NICU | 5 neonates |
| Placebo Group | Neonates Entering NICU | 2 neonates |
p-value: 0.46595% CI: [0.4, 10.39]Fisher Exact
Secondary
Number of Available Embryos
The sum of the number of embryos transferred and the number of embryos frozen.
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Number of Available Embryos | 4 embryos |
| Placebo Group | Number of Available Embryos | 3 embryos |
p-value: 0.163Wilcoxon (Mann-Whitney)
Secondary
Number of Cleavage
Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval.
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Number of Cleavage | 7 oocytes |
| Placebo Group | Number of Cleavage | 6 oocytes |
p-value: 0.289Wilcoxon (Mann-Whitney)
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).
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Number of High-quality Embryos | 2 embryos |
| Placebo Group | Number of High-quality Embryos | 2 embryos |
p-value: 0.178Wilcoxon (Mann-Whitney)
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.
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Number of Matured Oocytes Retrieved | 8 oocytes |
| Placebo Group | Number of Matured Oocytes Retrieved | 7 oocytes |
p-value: 0.528Wilcoxon (Mann-Whitney)
Secondary
Number of Retrieved Oocytes
The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration.
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Number of Retrieved Oocytes | 9 oocytes |
| Placebo Group | Number of Retrieved Oocytes | 9 oocytes |
p-value: 0.781Wilcoxon (Mann-Whitney)
Secondary
Preterm Delivery Among Live Birth
Delivery of a fetus at less than 37 and more than 28 weeks gestational age.
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Participants who had live birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zishen Yutai Pill Group | Preterm Delivery Among Live Birth | 29 Participants |
| Placebo Group | Preterm Delivery Among Live Birth | 22 Participants |
p-value: 0.78995% CI: [0.65, 1.78]Chi-squared
Secondary
Rate of Available Embryos
Rate of available embryos=Number of available embryos/Number of cleaved oocytes.
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Rate of Available Embryos | 57.1 percentage of available embryos |
| Placebo Group | Rate of Available Embryos | 50.0 percentage of available embryos |
p-value: 0.197Wilcoxon (Mann-Whitney)
Secondary
Rate of High-quality Embryos
Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Rate of High-quality Embryos | 50.0 percentage of high-quality embryos |
| Placebo Group | Rate of High-quality Embryos | 50.0 percentage of high-quality embryos |
p-value: 0.549Wilcoxon (Mann-Whitney)
Secondary
Rate of Matured Oocytes
Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Rate of Matured Oocytes | 90.0 percentage of matured oocytes |
| Placebo Group | Rate of Matured Oocytes | 90.9 percentage of matured oocytes |
p-value: 0.88Wilcoxon (Mann-Whitney)
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.
Time frame: On embryo transfer day, approximately 6 weeks
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zishen Yutai Pill Group | Rate of Retrieved Oocytes | 85.7 percentage of retrieved oocytes |
| Placebo Group | Rate of Retrieved Oocytes | 88.9 percentage of retrieved oocytes |
p-value: 0.609Wilcoxon (Mann-Whitney)
Secondary
The Birth Height of the Newborn
By checking medical records
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zishen Yutai Pill Group | The Birth Height of the Newborn | Singleton | 50.0 centimeter |
| Zishen Yutai Pill Group | The Birth Height of the Newborn | Twin | 48.0 centimeter |
| Placebo Group | The Birth Height of the Newborn | Singleton | 50.0 centimeter |
| Placebo Group | The Birth Height of the Newborn | Twin | 48.0 centimeter |
Comparison: Singletonp-value: 0.985Wilcoxon (Mann-Whitney)
Comparison: Twinp-value: 0.157Wilcoxon (Mann-Whitney)
Secondary
The Birth Weight of the Newborn
By checking medical records
Time frame: 1 year after embryo transfer, up to 58 weeks
Population: Newborns (145 singletons and 26 pairs of twins in Zishen Yutai pill group, 117 singletons and 22 pairs of twins in placebo group)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zishen Yutai Pill Group | The Birth Weight of the Newborn | Singleton | 3250.0 gram |
| Zishen Yutai Pill Group | The Birth Weight of the Newborn | Twin | 2450.0 gram |
| Placebo Group | The Birth Weight of the Newborn | Singleton | 3260.0 gram |
| Placebo Group | The Birth Weight of the Newborn | Twin | 2275.0 gram |
Comparison: Singletonp-value: 0.564Wilcoxon (Mann-Whitney)
Comparison: Twinp-value: 0.417Wilcoxon (Mann-Whitney)