Infertility, FemalePhase 3NCT04842825
Sequential Therapy of TCM Herbs to Improve the Success Rate of IVF-ET in Diminished Ovarian Reserve Patients
A Phase 3 study testing Er Zhi Wan combined with Si Wu Tang and Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder in people with Infertility, Female, run by Peking University Third Hospital at 1 site in China.
Trial summary
In the early stage, our team found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in vitro fertilization and embryo transfer(IVF-ET) can improve the clinical pregnancy rate. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Er Zhi Wan combined with Si Wu Tang and Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Consent to participate in this clinical trial and sign an informed consent form.
- Age ≤40 years, regular menstrual cycle between 21and 35 days in length.
- Meet the Western diagnostic criteria for DOR.
- Meet the criteria for identifying kidney deficiency in Chinese medicine.
- Planning to undergo IVF-ET for pregnancy.
Who cannot join
- History of two or more previous spontaneous abortions (excluding biochemical pregnancy abortions) or three or more previous ETs without obtaining a clinical pregnancy.
- Premature ovarian failure or ovarian gonadotropin resistance syndrome.
- Untreated uterine anomalies or abnormalities, including double uterus or longitudinal uterus (complete or incomplete).
- Untreated hydrocele on one or both fallopian tubes (confirmed by hysterosalpingography).
- Uterine adhesions, endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), or uterine fibroids >4 cm.
- Endocrine disorder affecting ovulation, such as polycystic ovary syndrome, hyperprolactinaemia, hyperandrogenaemia, hypothyroidism, or adrenal abnormalities.
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- Infertility with abnormal ovarian function due to immune factors, genetic factors, or congenital physical defects.
- Previous pelvic radiotherapy.
- Known or suspected sex hormone-related malignancy.
- Allergy to or intolerance of the drugs used in the study.
- Combined contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormalities of liver and kidney function, diabetes mellitus (glycosylated haemoglobin ≤7%, fasting blood glucose <10 mmol/L ), hypertension, thyroid disease, symptomatic heart disease, moderate to severe anaemia, history of malignancy or thromboembolism or propensity to thrombosis, severe psychiatric disorder, acute infections of the genitourinary system, sexually transmitted diseases, serious adverse habits such as drug abuse, exposure to teratogenic amounts of radiation, toxins, or drugs (such as prednisone or other hormones, adrenaline, antibiotics, or hypertension, cardiovascular, or antiviral medications) during the active procedure period , and uterine factor infertility or physical illness which prevents the ability to bear a pregnancy.
Trial locations and contacts
1 site in 1 country.
Ruiwen Fan contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, China
xiyan xin
About this study
Official title: A Randomized Controlled Study on Sequential Therapy of Kidney Tonifying and Blood Regulating Herbs to Improve the Success Rate of IVF-ET in Patients With Ovarian Reserve Dysfunction
In the early stage, our team found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in vitro fertilization and embryo transfer(IVF-ET) can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility due to decreased ovarian reserve (DOR). A randomized controlled clinical trial was used in this study. 200 infertile patients with DOR were randomly divided into two groups. The control group was treated with conventional modern medicine, and the treatment group was treated with traditional Chinese herbs on the basis of conventional modern medicine.
The intervention started from the 5th day of the first menstrual cycles after enrollment and lasted for three months before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, anti-Mullerian hormone(AMH), serum follicle-stimulating hormone(FSH), and clinical pregnancy rate will be observed to evaluate the effect of traditional Chinese medicine on the improvement of ovarian function, pregnancy outcome, and fertility of DOR patients.
Read the detailed description
The study will be conducted on patients with DOR attending our reproductive medicine centre for proposed IVF-ET between January 2021and December 2022.
The trial is designed as a randomised, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using herbs to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine.
Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.
Treatment method Phase I: The control group will be treated with conventional Western medicine, whereas the treatment group will receive sequential treatment with the Chinese herbal formula 2 months before the proposed embryo transfer(ET) to regulate menstruation and improve ovarian reserve function. Treatment with the Chinese herbal formula will start on the 5th day of menstruation after entering the super-ovulation cycle. The medicines used will be Er Zhi Wan combined with Si Wu Tang (Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 20 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 12 g, Radix Yam 20 g); which will be taken for 10-15days. After ovulation, the herbs used to warm the kidney and regulate the blood will be changed to Er Xian Promoting Pregnancy Decoction with Si Wu Decoction (Curculus 10 g, Xianling spleen 15 g, Morinda officinalis 15 g, Cuscutae 20 g, Amethyst 15 g, Rehmannia 20 g, Angelica 15 g, Chuanxiong 10 g); which will be taken for 10-15days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening.
Phase 2: After ET, the control group will be treated conventionally with no TCM intervention, and the treatment group will continue to take Chinese herbal medicine, changing to tonifying the kidney, regulating blood, and calming the foetus, using Shou Foetus pill combined with Si WuTang with addition and subtraction (Cuscuta 15 g, Sambucus 15 g, Chuan Guan Gong 10 g, Agaricus 9 g, Shu Di 15 g, Angelica 10 g, Bai Shao 12 g), which will be taken until the 14th day of transplantation.
Medication Patients that meet the inclusion criteria will be assigned to one of two groups according to a randomisation table after completing the relevant tests and signing the informed consent form. The control group will be treated routinely, and the treatment group will begin taking the assigned drugs on the 5th day (with no intervention drugs taken on days 1-4) of menstruation for two menstrual cycles before IVF until the day of ET and then continue the intervention for 14 days after ET.
Follow-up plan Blood tests to measure progesterone and human chorionic gonadotropin(hCG) will be performed 14 days after fresh or frozen ET. If the blood results confirm pregnancy, a clinical pregnancy will be confirmed after 2 weeks by vaginal ultrasound. When a gestational sac is seen in the uterus, the presence or absence of ectopic pregnancy and the number of implanted foetuses will be determined. Those with clinical pregnancy will be followed for final pregnancy outcome (miscarriage/live birth, week of delivery, and a number of new-borns), delivery (mode of delivery and pregnancy complications), and offspring (sex, weight, length, presence of birth defects, and stillbirth). Follow-up will be limited to subjects with transferred embryos obtained from egg retrieval in this study. In the case of subject withdrawal or dropout from the study, detailed reasons will be recorded.
- Conditions
- Infertility, Female
- Being tested
- Er Zhi Wan combined with Si Wu Tang, Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder
- Keywords
- infertility, traditional chinese medicine, ovarian reserve, Fertilization in Vitro, Embryo Transfer
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er Zhi Wan combined with Si Wu TangDrug
Also called conventional western medicine(Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )
The TCM medicines used will be Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 20 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 12 g, Radix Yam 20 g. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening, for 10-15 days. According to follicular development and endometrial growth monitored by ultrasound, the herbs will be changed to Curculus 10 g, Xianling spleen 15 g, Morinda officinalis 15 g, Cuscutae 20 g, Amethyst 15 g, Rehmannia 20 g, Angelica 15 g, Chuanxiong 10 g，which will be taken for 10-15days.
After ET, the treatment group will continue to take Chinese herbal medicine, changing to Cuscuta 15 g, Sambucus 15 g, Chuan Guan Gong 10 g, Agaricus 9 g, Shu Di 15 g, Angelica 10 g, Bai Shao 12 g for 14 days
Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate PowderDrug
Also called (Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )
The control group will be treated with conventional Western medicine（The specific drug dose is determined according to the individual level of patients）
| Study group | Role | What they receive |
|---|---|---|
| kidney-tonifying and blood-regulating herbs treatment group | Experimental | the treatment group will receive sequential treatment with the Chinese herbal formula for tonifying the kidney, nourishing the blood, and activating the blood 2 months before the proposed ET to regulate menstruation and improve ovarian reserve function. Treatment with the Chinese herbal formula will continue on the 5th day of menstruation after entering the super-ovulation cycle. Receives: Drug: Er Zhi Wan combined with Si Wu Tang |
| Western medicine group | Active comparator | The control group will be treated with conventional Western medicine Receives: Drug: Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eggs obtained
Obtained by blood sampling before the proposed IVF-ET
Measured: up to 15 weeks from enrollment
Change from Baseline concentration of Serum anti-Mullerian hormone(AMH) before the proposed IVF-ET
Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET
Measured: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Change from Baseline concentration of Serum follicle-stimulating hormone (FSH) before the proposed IVF-ET
Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET
Measured: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Clinical pregnancy rate (%): number of clinical pregnancies/total number of ET cycles
Follow up by telephone calls 30days after the IVF-ET
Measured: up to 19 weeks from the enrollment
Secondary outcomes (9)
Change from Baseline concentration of antral follicle count(AFC) before the proposed IVF-ET
Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET
Measured: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Concentration of follicular E2 level on the day of human chorionic gonadotropin(hCG) injection
Obtained by blood sampling before the proposed IVF-ET
Measured: up to 15 weeks from enrollment
Change from Baseline concentration of Serum luteinising hormone(LH) before the proposed IVF-ET
Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET
Measured: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Quality egg rate (%)
Before the proposed IVF-ET
Measured: up to 15 weeks from enrollment
Total amount of ovulation-promoting drugs
Before the proposed IVF-ET
Measured: up to 15 weeks from enrollment
Fertilisation rate (%)
Before the proposed IVF-ET
Measured: up to 15 weeks from enrollment
Implantation rate (%): number of gestational sacs/number of embryos transferred
30days after the IVF-ET
Measured: up to 19 weeks from the enrollment
Concentration of human chorionic gonadotropin(hCG)
14days after the IVF-ET
Measured: up to 17 weeks from the enrollment
Concentration of progesterone
14days after the IVF-ET
Measured: up to 17 weeks from the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Apr 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To further investigate its role in improving pregnancy outcomes of IVF-ET in diminished ovarian reserve (DOR) infertility, in this randomized, controlled clinical trial, 200 patients with DOR infertility who intended to undergo IVF-ET will be randomly divided into two groups: a treatment group (Western conventional treatment + kidney-tonifying and blood-regulating herbs) and a control group (Western treatment only). The intervention will be started from the 5th day of menstruation for two menstrual cycles before undergoing IVF-ET until 14 days after transfer.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Li, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842825
- Sponsor's protocol ID
- IRB00006761-M2020368
- Status last verified
- Jun 2021
- First submitted
- 17 Mar 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on Sequential Therapy of Kidney Tonifying and Blood Regulating Herbs to Improve the Success Rate of IVF-ET in Patients With Ovarian Reserve Dysfunction
- ClinicalTrials.gov ID
- NCT04842825
- Acronym / sponsor ID
- IRB00006761-M2020368
- Conditions
- Infertility, Female
- Keywords
- infertility, traditional chinese medicine, ovarian reserve, Fertilization in Vitro, Embryo Transfer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the early stage, our team found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in vitro fertilization and embryo transfer(IVF-ET) can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility due to decreased ovarian reserve (DOR). A randomized controlled clinical trial was used in this study. 200 infertile patients with DOR were randomly divided into two groups. The control group was treated with conventional modern medicine, and the treatment group was treated with traditional Chinese herbs on the basis of conventional modern medicine.
The intervention started from the 5th day of the first menstrual cycles after enrollment and lasted for three months before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, anti-Mullerian hormone(AMH), serum follicle-stimulating hormone(FSH), and clinical pregnancy rate will be observed to evaluate the effect of traditional Chinese medicine on the improvement of ovarian function, pregnancy outcome, and fertility of DOR patients.
Detailed description
The study will be conducted on patients with DOR attending our reproductive medicine centre for proposed IVF-ET between January 2021and December 2022.
The trial is designed as a randomised, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using herbs to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine.
Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.
Treatment method Phase I: The control group will be treated with conventional Western medicine, whereas the treatment group will receive sequential treatment with the Chinese herbal formula 2 months before the proposed embryo transfer(ET) to regulate menstruation and improve ovarian reserve function. Treatment with the Chinese herbal formula will start on the 5th day of menstruation after entering the super-ovulation cycle. The medicines used will be Er Zhi Wan combined with Si Wu Tang (Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 20 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 12 g, Radix Yam 20 g); which will be taken for 10-15days. After ovulation, the herbs used to warm the kidney and regulate the blood will be changed to Er Xian Promoting Pregnancy Decoction with Si Wu Decoction (Curculus 10 g, Xianling spleen 15 g, Morinda officinalis 15 g, Cuscutae 20 g, Amethyst 15 g, Rehmannia 20 g, Angelica 15 g, Chuanxiong 10 g); which will be taken for 10-15days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening.
Phase 2: After ET, the control group will be treated conventionally with no TCM intervention, and the treatment group will continue to take Chinese herbal medicine, changing to tonifying the kidney, regulating blood, and calming the foetus, using Shou Foetus pill combined with Si WuTang with addition and subtraction (Cuscuta 15 g, Sambucus 15 g, Chuan Guan Gong 10 g, Agaricus 9 g, Shu Di 15 g, Angelica 10 g, Bai Shao 12 g), which will be taken until the 14th day of transplantation.
Medication Patients that meet the inclusion criteria will be assigned to one of two groups according to a randomisation table after completing the relevant tests and signing the informed consent form. The control group will be treated routinely, and the treatment group will begin taking the assigned drugs on the 5th day (with no intervention drugs taken on days 1-4) of menstruation for two menstrual cycles before IVF until the day of ET and then continue the intervention for 14 days after ET.
Follow-up plan Blood tests to measure progesterone and human chorionic gonadotropin(hCG) will be performed 14 days after fresh or frozen ET. If the blood results confirm pregnancy, a clinical pregnancy will be confirmed after 2 weeks by vaginal ultrasound. When a gestational sac is seen in the uterus, the presence or absence of ectopic pregnancy and the number of implanted foetuses will be determined. Those with clinical pregnancy will be followed for final pregnancy outcome (miscarriage/live birth, week of delivery, and a number of new-borns), delivery (mode of delivery and pregnancy complications), and offspring (sex, weight, length, presence of birth defects, and stillbirth). Follow-up will be limited to subjects with transferred embryos obtained from egg retrieval in this study. In the case of subject withdrawal or dropout from the study, detailed reasons will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- To further investigate its role in improving pregnancy outcomes of IVF-ET in diminished ovarian reserve (DOR) infertility, in this randomized, controlled clinical trial, 200 patients with DOR infertility who intended to undergo IVF-ET will be randomly divided into two groups: a treatment group (Western conventional treatment + kidney-tonifying and blood-regulating herbs) and a control group (Western treatment only). The intervention will be started from the 5th day of menstruation for two menstrual cycles before undergoing IVF-ET until 14 days after transfer.
| Arm | Type | Receives |
|---|---|---|
| kidney-tonifying and blood-regulating herbs treatment group | Experimental | Drug: Er Zhi Wan combined with Si Wu Tangthe treatment group will receive sequential treatment with the Chinese herbal formula for tonifying the kidney, nourishing the blood, and activating the blood 2 months before the proposed ET to regulate menstruation and improve ovarian reserve function. Treatment with the Chinese herbal formula will continue on the 5th day of menstruation after entering the super-ovulation cycle. |
| Western medicine group | Active comparator | Drug: Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate PowderThe control group will be treated with conventional Western medicine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Consent to participate in this clinical trial and sign an informed consent form.
- Age ≤40 years, regular menstrual cycle between 21and 35 days in length.
- Meet the Western diagnostic criteria for DOR.
- Meet the criteria for identifying kidney deficiency in Chinese medicine.
- Planning to undergo IVF-ET for pregnancy.
Key exclusion criteria (11 listed)
- History of two or more previous spontaneous abortions (excluding biochemical pregnancy abortions) or three or more previous ETs without obtaining a clinical pregnancy.
- Premature ovarian failure or ovarian gonadotropin resistance syndrome.
- Untreated uterine anomalies or abnormalities, including double uterus or longitudinal uterus (complete or incomplete).
- Untreated hydrocele on one or both fallopian tubes (confirmed by hysterosalpingography).
- Uterine adhesions, endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), or uterine fibroids >4 cm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Er Zhi Wan combined with Si Wu TangAlso: conventional western medicine(Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )The TCM medicines used will be Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 20 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 12 g, Radix Yam 20 g. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening, for 10-15 days. According to follicular development and endometrial growth monitored by ultrasound, the herbs will be changed to Curculus 10 g, Xianling spleen 15 g, Morinda officinalis 15 g, Cuscutae 20 g, Amethyst 15 g, Rehmannia 20 g, Angelica 15 g, Chuanxiong 10 g，which will be taken for 10-15days. After ET, the treatment group will continue to take Chinese herbal medicine, changing to Cuscuta 15 g, Sambucus 15 g, Chuan Guan Gong 10 g, Agaricus 9 g, Shu Di 15 g, Angelica 10 g, Bai Shao 12 g for 14 days | Drug | kidney-tonifying and blood-regulating herbs treatment group |
| Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate PowderAlso: (Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )The control group will be treated with conventional Western medicine（The specific drug dose is determined according to the individual level of patients） | Drug | Western medicine group |
Primary outcome
Number of eggs obtained
Time frame: up to 15 weeks from enrollment
Obtained by blood sampling before the proposed IVF-ET
Change from Baseline concentration of Serum anti-Mullerian hormone(AMH) before the proposed IVF-ET
Time frame: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET
Change from Baseline concentration of Serum follicle-stimulating hormone (FSH) before the proposed IVF-ET
Time frame: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET
Clinical pregnancy rate (%): number of clinical pregnancies/total number of ET cycles
Time frame: up to 19 weeks from the enrollment
Follow up by telephone calls 30days after the IVF-ET
9 secondary outcomes
Change from Baseline concentration of antral follicle count(AFC) before the proposed IVF-ET
Time frame: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Concentration of follicular E2 level on the day of human chorionic gonadotropin(hCG) injection
Time frame: up to 15 weeks from enrollment
Change from Baseline concentration of Serum luteinising hormone(LH) before the proposed IVF-ET
Time frame: The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）
Quality egg rate (%)
Time frame: up to 15 weeks from enrollment
Total amount of ovulation-promoting drugs
Time frame: up to 15 weeks from enrollment
Fertilisation rate (%)
Time frame: up to 15 weeks from enrollment
Implantation rate (%): number of gestational sacs/number of embryos transferred
Time frame: up to 19 weeks from the enrollment
Concentration of human chorionic gonadotropin(hCG)
Time frame: up to 17 weeks from the enrollment
Concentration of progesterone
Time frame: up to 17 weeks from the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruiwen Fan contact
Dong Li study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Er Zhi Wan combined with Si Wu Tang and Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder in people with Infertility, Female, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiyan Xin (+86 0108226-4621, xinxiyan198234@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eggs obtained (time frame: up to 15 weeks from enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.