Diminished Ovarian ReservePhase 3NCT05577455
Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients
A Phase 3 study testing Medical prescription before ovulation and Medical prescription after ovulation in people with Diminished Ovarian Reserve and Infertility, Female, run by Peking University Third Hospital.
Trial summary
Patients with diminished ovarian reserve (DOR) who undergo in vitro fertilization and embryo transfer (IVF-ET) are included as the research subjects. The effects of Traditional Chinese Medicine (TCM) for kidney tonifying and blood circulation regulating of different intervention courses on ovarian hyporesponsiveness… Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve, Infertility, Female
- What is being tested?
- Medical prescription before ovulation and Medical prescription after ovulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2022to 30 Dec 2024
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, 20 years old ≤ age ≤ 42 years old;
- The menstrual cycle is generally regular; 21 days < menstrual cycle < 35 days;
- Those who meet the diagnostic criteria for DOR in Western medicine;
- Those who meet the TCM differential criteria of kidney deficiency syndrome;
- Those who are scheduled to undergo IVF-ET;
- Those who voluntarily participate in this clinical trial and sign a written informed consent.
Who cannot join
- Those who have a history of two or more spontaneous abortions (excluding biochemical pregnancy abortion) or three or more previous transplantations without achieving clinical pregnancy;
- Those who have premature ovarian failure or ovarian gonadotropin resistance syndrome;
- Those who have untreated uterine malformation or abnormality: double uterus, septate uterus (complete or incomplete);
- Those who have untreated unilateral or bilateral hydrosalpinx;
- Those who have uncured endometrial diseases (such as endometritis, endometrial polyps, endometriosis), adenomyosis, intrauterine adhesions, etc., and those with uterine fibroids of more than 4 cm;
- Those who have endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, abnormal adrenal function, etc., which affect ovulation;
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- Infertile patients with abnormal ovarian function caused by immunological factors, genetic factors or congenital physiological defects;
- Those who have received pelvic radiotherapy;
- Those who are known or suspected of having sex hormone-related malignant tumors;
- Those who are allergic or intolerable to the medications involved in the study;
- Those with contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormal liver and renal function, diabetes, hypertension, thyroid disease, symptomatic heart disease, moderate to severe anemia, history of malignant tumor or history of thromboembolism or thrombosis formation tendency, serious mental illness, acute infection of urogenital system, sexually transmitted disease, extremely bad habits such as drug use, exposure to teratogenic radiation, poison, drugs (such as prednisone and other hormones, epinephrine, antibiotics, antihypertensive drugs, cardiovascular and cerebrovascular drugs, antiviral drugs) and are still under the effect of the drugs; and those whose uterus is unable to perform the function of pregnancy or who are intolerant of pregnancy due to physical diseases during pregnancy;
- Those who have taken other TCMs or proprietary Chinese medicines that can invigorate the kidney or affect the evaluation of drug efficacy in the past 30 days;
- Other patients who are deemed unsuitable to participate in this study by the researchers;
- Those who are participating in other clinical trials;
- Those who do not agree to participate in this study or do not sign the informed consent form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-inferiority Randomized Controlled Study on Kidney Tonifying and Blood Circulation Regulating Therapy (Bu Shen Tiao Xue) of Different Intervention Courses in Improving IVF-ET Pregnancy Outcomes in DOR Patients
Patients with diminished ovarian reserve (DOR) who undergo in vitro fertilization and embryo transfer (IVF-ET) are included as the research subjects. The effects of Traditional Chinese Medicine (TCM) for kidney tonifying and blood circulation regulating of different intervention courses on ovarian hyporesponsiveness, IVF-ET outcome and clinical compliance in DOR patients are studied by a non-inferiority randomized controlled trial. The purpose is to identify the breakthrough point and treatment timing of TCM treatment, explore the best treatment course of TCM, and optimize the TCM therapeutic regimen.
Read the detailed description
IVF-ET is one of the major techniques to treat infertility in DOR patients, but poor ovarian response and low pregnancy rate have been the bottleneck problems. China has original advantages in Traditional Chinese Medicine (TCM) treatment. The kidney tonifying and blood circulation regulating therapy is a pre-IVF-ET intervention treatment characterized by sequential treatment according to menstrual cycle formed in the previous investigations by the research group. It can ameliorate ovarian hyporesponsiveness and improve the success rate of IVF-ET, but the compliance is poor due to the long intervention course. Identifying the time point of TCM intervention to further optimize the treatment plan is the key to improving the pregnancy rate. Therefore, DOR patients who receive IVF-ET are enrolled as the research objects in this project, who are divided into the experimental group and control group with a randomized controlled non-inferiority design, and receive sequential TCM therapy for kidney tonifying and blood circulation regulating from the fifth day of menstruation at the second menstrual cycle and the third menstrual cycle prior to IVF-ET, respectively, until the day of human chorionic gonadotrophin (hCG) administration. The number of oocytes retrieved, the rate of high-quality embryos, the dosage and administration days of Gn, the levels of estradiol (E2) and progesterone (P) and the clinical pregnancy rate on hCG day are compared between the two groups. Meanwhile, the compliance of patients in the two groups with different treatment regimens is compared. This project aims to verify that the efficacy of the treatment plan implemented from the second menstrual cycle prior to IVF-ET may not be inferior to that from the third menstrual cycle prior to IVF-ET on improving the pregnancy outcomes of DOR patients, while the compliance is better. The results of the study will provide a reference basis for the precise treatment of TCM prior to IVF-ET.
- Conditions
- Diminished Ovarian Reserve, Infertility, Female
- Being tested
- Medical prescription before ovulation, Medical prescription after ovulation
- Keywords
- traditional Chinese medicine, in vitro fertilization and embryo transfer, diminished ovarian reserve
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical prescription before ovulationDrug
Medical prescription before ovulation, modified two solstices pill and Si-Wu-Tang: 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 10g of Mo Han Lian (Yerbadetajo herb), 15g of Gou Qi Zi (Fructus lycii), 20g of Tu Si Zi (Semen cuscutae), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), 20g of Sheng Shan Yao (Rhizoma Dioscoreae), 15g of Fu Pen Zi (Raspberry), and 15g of Shan Yu Rou (Fructus corni). The medical prescription is initiated on the fifth day of menstruation and is taken continuously for 10-15 days.
Medical prescription after ovulationDrug
Medical prescription after ovulation, modified Er Xian decoction for promoting fertilization and Si-Wu-Tang: 10g of Xian Mao (Curculigo orchioides), 15g of Xian Ling Pi (Epimedium Herb), 15g of Ba Ji Tian (Morinda officinalis), 20g of Tu Si Zi (Semen cuscutae), 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 15g of Zi Shi Ying (Fluoritum), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), and 10g of Chuan Xiong (Szechwan Lovage Rhizome). The medical prescription is administered continuously for 10-15 days after ovulation, based on follicle development and endometrial growth monitored by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| administration for 2 menstrual cycles group | Experimental | This group will receive TCM treatment before 2 menstrual cycles of IVF-ET. Receives: Drug: Medical prescription before ovulation; Drug: Medical prescription after ovulation |
| administration for 3 menstrual cycles group | Active comparator | This group will receive TCM treatment before 3 menstrual cycles of IVF-ET. Receives: Drug: Medical prescription before ovulation; Drug: Medical prescription after ovulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
The number of oocytes retrieved by puncture under the guidance of vaginal ultrasound
Measured: up to 15 weeks from enrollment
Secondary outcomes (12)
High-quality embryo rate (%)
Number of high-quality embryos / the total number of normal cleavage embryos × 100%
Measured: up to 15 weeks from enrollment
Clinical pregnancy rate
Ultrasound monitoring is performed 30 days after embryo transfer
Measured: up to 15 weeks from enrollment
Compliance with the treatment plan
The situation of continuous treatment of the research subjects is recorded; the compliance of the experimental group = the number of cases who receive continuous treatment for 2 months / the total number of patients in the experimental group; the compliance of the control group = the number of cases who receive continuous treatment for 3 months / the total number of patients in the control group
Measured: up to 15 weeks from enrollment
Gonadotrophin (Gn) administration day
Record the total gonadotrophin (Gn) administration day
Measured: up to 15 weeks from enrollment
Gn dosage
Record the average dose of Gn administration
Measured: up to 15 weeks from enrollment
Levels of LH
Obtained by blood sampling
Measured: up to 15 weeks from enrollment
Levels of E2
Obtained by blood sampling
Measured: up to 15 weeks from enrollment
Levels of P
Obtained by blood sampling
Measured: up to 15 weeks from enrollment
Antral follicle count (AFC)
Changes of AFC before and after TCM intervention
Measured: up to 15 weeks from enrollment
Levels of FSH
Obtained by blood sampling
Measured: up to 15 weeks from enrollment
Levels of AMH
Obtained by blood sampling
Measured: up to 15 weeks from enrollment
Health economics indicators
Average daily cost and total cost
Measured: up to 15 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start10 Nov 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian ReserveStudies 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
- After the patients complete the relevant examinations, and those who meet the inclusion criteria sign the informed consent, they are sequentially assigned to two groups according to the randomization table. The intervention begins from the second menstrual cycle prior to IVF-ET in the experimental group and third menstrual cycle prior to IVF-ET in the control group. TCM treatment is initiated on the 5th day of menstruation in both groups, and medical prescriptions before and after ovulation are administered successively. Subjects do not take any medicine on the 1st to 4th day of menstruation and medications are discontinued on the day of HCG. The TCM is decocted by our hospital, and patients are instructed to take one dose of the the decoction warm per day (400 ml per dose) one hour after meals twice (once in the morning and once in the evening). The occurrence of spontaneous pregnancy and adverse reactions are recorded and dealt with promptly throughout the drug application period.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 266 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
- NCT05577455
- Sponsor's protocol ID
- IRB00006761-M2022270
- Status last verified
- Sep 2022
- First submitted
- 9 Oct 2022
- Last updated
- 27 Oct 2022
- 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Randomized Controlled Study on Kidney Tonifying and Blood Circulation Regulating Therapy (Bu Shen Tiao Xue) of Different Intervention Courses in Improving IVF-ET Pregnancy Outcomes in DOR Patients
- ClinicalTrials.gov ID
- NCT05577455
- Acronym / sponsor ID
- IRB00006761-M2022270
- Conditions
- Diminished Ovarian Reserve, Infertility, Female
- Keywords
- traditional Chinese medicine, in vitro fertilization and embryo transfer, diminished ovarian reserve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
Patients with diminished ovarian reserve (DOR) who undergo in vitro fertilization and embryo transfer (IVF-ET) are included as the research subjects. The effects of Traditional Chinese Medicine (TCM) for kidney tonifying and blood circulation regulating of different intervention courses on ovarian hyporesponsiveness, IVF-ET outcome and clinical compliance in DOR patients are studied by a non-inferiority randomized controlled trial. The purpose is to identify the breakthrough point and treatment timing of TCM treatment, explore the best treatment course of TCM, and optimize the TCM therapeutic regimen.
Detailed description
IVF-ET is one of the major techniques to treat infertility in DOR patients, but poor ovarian response and low pregnancy rate have been the bottleneck problems. China has original advantages in Traditional Chinese Medicine (TCM) treatment. The kidney tonifying and blood circulation regulating therapy is a pre-IVF-ET intervention treatment characterized by sequential treatment according to menstrual cycle formed in the previous investigations by the research group. It can ameliorate ovarian hyporesponsiveness and improve the success rate of IVF-ET, but the compliance is poor due to the long intervention course. Identifying the time point of TCM intervention to further optimize the treatment plan is the key to improving the pregnancy rate. Therefore, DOR patients who receive IVF-ET are enrolled as the research objects in this project, who are divided into the experimental group and control group with a randomized controlled non-inferiority design, and receive sequential TCM therapy for kidney tonifying and blood circulation regulating from the fifth day of menstruation at the second menstrual cycle and the third menstrual cycle prior to IVF-ET, respectively, until the day of human chorionic gonadotrophin (hCG) administration. The number of oocytes retrieved, the rate of high-quality embryos, the dosage and administration days of Gn, the levels of estradiol (E2) and progesterone (P) and the clinical pregnancy rate on hCG day are compared between the two groups. Meanwhile, the compliance of patients in the two groups with different treatment regimens is compared. This project aims to verify that the efficacy of the treatment plan implemented from the second menstrual cycle prior to IVF-ET may not be inferior to that from the third menstrual cycle prior to IVF-ET on improving the pregnancy outcomes of DOR patients, while the compliance is better. The results of the study will provide a reference basis for the precise treatment of TCM prior to IVF-ET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- After the patients complete the relevant examinations, and those who meet the inclusion criteria sign the informed consent, they are sequentially assigned to two groups according to the randomization table. The intervention begins from the second menstrual cycle prior to IVF-ET in the experimental group and third menstrual cycle prior to IVF-ET in the control group. TCM treatment is initiated on the 5th day of menstruation in both groups, and medical prescriptions before and after ovulation are administered successively. Subjects do not take any medicine on the 1st to 4th day of menstruation and medications are discontinued on the day of HCG. The TCM is decocted by our hospital, and patients are instructed to take one dose of the the decoction warm per day (400 ml per dose) one hour after meals twice (once in the morning and once in the evening). The occurrence of spontaneous pregnancy and adverse reactions are recorded and dealt with promptly throughout the drug application period.
| Arm | Type | Receives |
|---|---|---|
| administration for 2 menstrual cycles group | Experimental | Drug: Medical prescription before ovulation, Drug: Medical prescription after ovulationThis group will receive TCM treatment before 2 menstrual cycles of IVF-ET. |
| administration for 3 menstrual cycles group | Active comparator | Drug: Medical prescription before ovulation, Drug: Medical prescription after ovulationThis group will receive TCM treatment before 3 menstrual cycles of IVF-ET. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, 20 years old ≤ age ≤ 42 years old;
- The menstrual cycle is generally regular; 21 days < menstrual cycle < 35 days;
- Those who meet the diagnostic criteria for DOR in Western medicine;
- Those who meet the TCM differential criteria of kidney deficiency syndrome;
- Those who are scheduled to undergo IVF-ET;
Key exclusion criteria (15 listed)
- Those who have a history of two or more spontaneous abortions (excluding biochemical pregnancy abortion) or three or more previous transplantations without achieving clinical pregnancy;
- Those who have premature ovarian failure or ovarian gonadotropin resistance syndrome;
- Those who have untreated uterine malformation or abnormality: double uterus, septate uterus (complete or incomplete);
- Those who have untreated unilateral or bilateral hydrosalpinx;
- Those who have uncured endometrial diseases (such as endometritis, endometrial polyps, endometriosis), adenomyosis, intrauterine adhesions, etc., and those with uterine fibroids of more than 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 |
|---|---|---|
| Medical prescription before ovulationMedical prescription before ovulation, modified two solstices pill and Si-Wu-Tang: 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 10g of Mo Han Lian (Yerbadetajo herb), 15g of Gou Qi Zi (Fructus lycii), 20g of Tu Si Zi (Semen cuscutae), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), 20g of Sheng Shan Yao (Rhizoma Dioscoreae), 15g of Fu Pen Zi (Raspberry), and 15g of Shan Yu Rou (Fructus corni). The medical prescription is initiated on the fifth day of menstruation and is taken continuously for 10-15 days. | Drug | administration for 2 menstrual cycles group, administration for 3 menstrual cycles group |
| Medical prescription after ovulationMedical prescription after ovulation, modified Er Xian decoction for promoting fertilization and Si-Wu-Tang: 10g of Xian Mao (Curculigo orchioides), 15g of Xian Ling Pi (Epimedium Herb), 15g of Ba Ji Tian (Morinda officinalis), 20g of Tu Si Zi (Semen cuscutae), 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 15g of Zi Shi Ying (Fluoritum), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), and 10g of Chuan Xiong (Szechwan Lovage Rhizome). The medical prescription is administered continuously for 10-15 days after ovulation, based on follicle development and endometrial growth monitored by ultrasound. | Drug | administration for 2 menstrual cycles group, administration for 3 menstrual cycles group |
Primary outcome
Number of oocytes retrieved
Time frame: up to 15 weeks from enrollment
The number of oocytes retrieved by puncture under the guidance of vaginal ultrasound
12 secondary outcomes
High-quality embryo rate (%)
Time frame: up to 15 weeks from enrollment
Clinical pregnancy rate
Time frame: up to 15 weeks from enrollment
Compliance with the treatment plan
Time frame: up to 15 weeks from enrollment
Gonadotrophin (Gn) administration day
Time frame: up to 15 weeks from enrollment
Gn dosage
Time frame: up to 15 weeks from enrollment
Levels of LH
Time frame: up to 15 weeks from enrollment
Levels of E2
Time frame: up to 15 weeks from enrollment
Levels of P
Time frame: up to 15 weeks from enrollment
Antral follicle count (AFC)
Time frame: up to 15 weeks from enrollment
Levels of FSH
Time frame: up to 15 weeks from enrollment
Levels of AMH
Time frame: up to 15 weeks from enrollment
Health economics indicators
Time frame: up to 15 weeks from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- 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.
Dong Li study chair
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medical prescription before ovulation and Medical prescription after ovulation in people with Diminished Ovarian Reserve and Infertility, Female, run by Peking University Third Hospital.
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 6 inclusion and 15 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 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 ext. 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 oocytes retrieved (time frame: up to 15 weeks from enrollment). 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 27 Oct 2022.