Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Luteinized Unruptured Follicle Syndrome; Ovarian Insufficiency; Polycystic Ovarian Syndrome; Abnormal Uterine Bleeding-Ovulatory Disorders; Anovulatory Infertility; Hyperprolactinemia; Corpus Luteum Insufficiency

Treatments: Drug: control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo; Drug: experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03709849

Z171100001017104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 528 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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528 participants in 2 patient groups

experimental group

Experimental group

Description:

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.

Treatment:

Drug: control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo

Drug: experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo

control group

Active Comparator group

Description:

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.

Treatment:

Drug: control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo

Drug: experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo