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Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

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ClinicalTrials.gov Identifier: NCT03709849
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Dongzhimen Hospital, Beijing
Beijing Obstetrics and Gynecology Hospital
Beijing Hospital of Traditional Chinese Medicine
Beijing First Hospital of integrated Chinese and Western Medicine
Beijing Fengtai Hospital of Integrated Traditional and Western Medicine
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
This study is to evaluate the effectiveness and safety of Bushen Culuan Decoction in the treatment of anovulatory infertility, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency, through a randomised, double-blinded, double-dummy, parallel positive controlled, adaptive multicenter clinical trial.

Condition or disease Intervention/treatment Phase
Anovulatory Infertility Abnormal Uterine Bleeding-Ovulatory Disorders Polycystic Ovarian Syndrome Hyperprolactinemia Luteinized Unruptured Follicle Syndrome Corpus Luteum Insufficiency Ovarian Insufficiency Drug: experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo Drug: control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo Phase 2

Detailed Description:

Anovulation is one of the main causes of female infertility. Anovulatory infertility account for a proportion of 25-30% in whole female infertility.

In western medicine, hormone induced ovulation and assisted reproduction technology are two main ways to solve the problem and Clomiphene citrate is the first-line medication in ovulation induction. There are many side effects being reported in the treatment with modern medicine technique such as ovarian hyperstimulation syndrome, complication with uteroscope and puncture egg retrieval, low pregnancy rate with high ovulation rate, potential cancer occuring risk and offspring healthy risk.

Bushen Culuan Decoction is a traditional Chinese medicine recipe with 10 Chinese herbs including Tusizi, Yinyanghuo, Xianmao, Xuduan, Gouqizi, Nvzhenzi, Zelan, Shengpuhuang, Xiangfu and Chuanshanlong. Previous laboratory and exploratory clinical researches have proved Bushen Culuan Decoction had an exactly efficacy in treating anovulatory infertility safely.

In the first stage, the primary sample size In the study is 528. Half patients will receive Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive clomiphene citrate tablets and Bushen Culuan Decoction placebo. When 1/3 of 528 patients complete the treatment, we will analysis the treatment efficacy of 6 diseases separately, and find which of them could be the target diseases of Bushen Culuan Decoction. Then we will modify the sample size depending on the result in first stage, and the research will only be processed in the target diseases being chosen. In the next stage, half patients will receive Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive clomiphene citrate tablets and Bushen Culuan Decoction placebo.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility:A Clinical Research of "Same Treatment for Different Diseases"
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: experimental group
Intervention, dosage and frequency: drug: Bushen Culuan Decoction 13g tid and Clomiphene Citrate Tablets placebo 50mg qd; Dosage form: Bushen Culuan Decoction is dissolved medicine and Clomiphene Citrate Tablets placebo is tablets; Duration: the medicine will be taken from 5th day of a menstrual cycle, Bushen Culuan Decoction is taken for 14 days while Clomiphene Citrate Tablets placebo being taken for 5 days. Then patients stop taking the medicine until the 5th day of next menstrual cycle. If the patient doesn't have a regular menstrual cycle, the medicine will be taken from 5th day from vaginal bleeding caused by taking progesterone. Each treatment cycle contains 3 menstrual cycle. If the patient regains normal ovulation at the end of the first treatment cycle, she will reach the end of the whole treatment, and if not she will start the second treatment cycle. All treatment will be terminated after 2 treatment cycles.
Drug: experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo
the same as group description including dosage, frequency and duration

Drug: control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo
the same as group description including dosage, frequency and duration
Other Name: brand name of Clomiphene Citrate Tablets: Fertilan

Active Comparator: control group
Intervention, dosage and frequency: drug: Clomiphene Citrate Tablets 50mg qd and Bushen Culuan Decoction placebo 13g tid; Dosage form: Clomiphene Citrate Tablets is tablet and Bushen Culuan Decoction placebo is dissolved medicine; Duration: the medicine will be taken from 5th day of a menstrual cycle, Clomiphene is taken for 5 days while Bushen Culuan Decoction placebo being taken for 14 days while. Then patients stop taking the medicine until the 5th day of next menstrual cycle. If the patient doesn't have a regular menstrual cycle, the medicine will be taken from 5th day from vaginal bleeding caused by taking progesterone. Each treatment cycle contains 3 menstrual cycle. If the patient regains normal ovulation at the end of the first treatment cycle, she will reach the end of the whole treatment, and if not she will start the second treatment cycle. All treatment will be terminated after 2 treatment cycles.
Drug: experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo
the same as group description including dosage, frequency and duration

Drug: control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo
the same as group description including dosage, frequency and duration
Other Name: brand name of Clomiphene Citrate Tablets: Fertilan




Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: Within 12 menstrual cycles from the first time that patient taking medicines. (Each cycle is 28 days) ]

Secondary Outcome Measures :
  1. Ovulation Rate [ Time Frame: At every ovulation phase (about day14 in a period cycle) within 3 or 6 menstrual cycles from the first time that patient taking medicines. (Each cycle is 28 days) ]
    If the patient participate 1 treatment cycle, the ovulation will be measured 3 menstrual cycles, and if the patient participate 2 treatment cycle, the ovulation will be measured 6 menstrual cycles.

  2. Basal Body Temperature [ Time Frame: At every morning within 3 or 6 menstrual cycles from the first time that patient taking medicines to the end of the treatment. (Each cycle is 28 days) ]
  3. Endocrine Hormone [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]
    Including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Prolactin (PRL), Estradiol (E2), Progesterone(P), Testosterone (T).

  4. Inhibin B [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]
  5. Anti-Mullerian Hormone (AMH) [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]
  6. Gynecologic Ultrasonography Routine [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]
    Including antral follicle count, volume of uterus and bilateral ovaries, thickness and type of endometrium.

  7. the Size of Dominant Follicle [ Time Frame: At every ovulation phase (about day14 in a period cycle) within 3 or 6 menstrual cycles from the first time that patient taking medicines. (Each cycle is 28 days) ]
  8. Blood Flow Index [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]
    Including peak-systolic flow velocity, pulsatility index and resistent index of uterus and bilateral ovaries

  9. Coagulation Indicator [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]
    Including prothrombin time, activated partial thromboplastin time, fibrinogen and thrombin time

  10. Traditional Chinese Medicine Symptom Score [ Time Frame: At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days) ]

    Traditional Chinese Medicine Symptom Score (point) including:

    amenorrhea (0-3); delayed menstruation (0-3); scant menstruation (0-3); weakness in lower back, waist and knees (0-3); dizziness and tinnitus (0-3); sexual apathy (0-3); fatigue (0-3); colorless transparent urination(0-3); frequent urination at night (0-3); feeling obstruction with menstruation (0-3); profuse menstruation with dark color (0-3); clot in menstruation (0-3); stabbing pain in lower abdomen area, may aggravating with sexual intercourse (0-3); dysmenorrhea (0-3) The total score will be measured by summing the subitems' score above, and the total score range is 0-42. The higher the score is, the worse the situation is.




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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 21~40 years old;
  2. Diagnosed with infertility;
  3. Diagnosed with one of below diseases: anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency,
  4. Diagnosed with TCM syndrome of kidney deficiency and blood stasis syndrome;
  5. Patients who has normal sexual intercourse during treatment;
  6. Voluntary to sign the informed consent.

Exclusion Criteria:

  1. Infertility due to congenital physiological defect or malformation;
  2. Infertility due to hereditary factors;
  3. Infertility due to oviduct defect, immune factors, uterine fibroid, adenomyosis, endometriosis or hypoplasia of uterus;
  4. Spouse has reproductive defects;
  5. Severe abnormity of cardiovascular system, liver function, kidney function or hemopoietic system;
  6. Allergy to experimental drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709849


Contacts
Contact: Kun Ma, Dr. 86-010-64089750 makun12348@sina.com
Contact: Yuan Yuan, Master 86-15801296950 gloriaflx0515@sina.com

Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Dongzhimen Hospital, Beijing
Beijing Obstetrics and Gynecology Hospital
Beijing Hospital of Traditional Chinese Medicine
Beijing First Hospital of integrated Chinese and Western Medicine
Beijing Fengtai Hospital of Integrated Traditional and Western Medicine
Investigators
Principal Investigator: Kun Ma, Dr. Xiyuan Hospital of China Academy of Chinese Medical Sciences

Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03709849     History of Changes
Other Study ID Numbers: Z171100001017104
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences:
Anovulatory Infertility
Bushen Culuan Decoction

Additional relevant MeSH terms:
Infertility
Syndrome
Polycystic Ovary Syndrome
Uterine Hemorrhage
Hyperprolactinemia
Anovulation
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Uterine Diseases
Hemorrhage
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants