Clinical trial NCT02624076: Acupuncture for Unexplained Subfertiliy
Official title: A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unexplained Infertility
Keywords: unexplained infertility
Acupuncture
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 1423
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Acupuncture is being increasingly used by couples with all types of infertility and initial trials have suggested that it could be potentially beneficial in some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting results, but there is no evidence to inform best practice in unexplained infertility. In addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could have the potential to increase live birth rates in women with unexplained infertility, the clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a large randomized controlled trial.


Eligibility criteria: Inclusion criteria

1. Women aged 18-40 years
2. Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy
3. Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010)

Exclusion criteria

1. Unwillingness to accept either of the two interventions
2. Contra-indications to acupuncture: pacemaker use or bleeding disorder
3. Received acupuncture before 2 months for other diseases which are not related to unexplained infertility.
4. Previously received acupuncture for unexplained infertility
5. Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months.
6. Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).

Primary outcomes:
measure: live birth rate
timeFrame: Up to 4 months
Secondary outcomes:
measure: pregnancy rate
timeFrame: Up to 14 months
measure: Miscarriage rate
timeFrame: Up to 14 months
measure: Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies.
timeFrame: Up to 14 months
measure: quality of life
timeFrame: Up to 14 months
measure: Side effect
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Medical School First Affiliated Hospital
state: Guangdong
city: Daqing
country: China
facility: The Daqing Oilfield General Hospital
state: Heilongjiang
city: Daqing
country: China
facility: Daqing Longnan hospital
state: Heilongjiang
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Harbin
country: China
facility: Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
state: Heilongjiang
city: Harbin
country: China
facility: Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Changsha
country: China
facility: First Affiliated Hospital of Hunan University of Chinese
state: Hunan
city: Xuzhou
country: China
facility: Maternal and Child Health Hospital of Xuzhou
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi University of Chinese Medicine Affiliated Hospital
state: Jiangxi
city: Nanchang
country: China
facility: First Hospital, Jiangxi college of Chinese Medicine
state: Jiangxi
city: Shangxi
country: China
facility: Shanxi Chinese Medicine Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Hospital of Chinese Medicine
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Tanggu Maternity and Child Care Center
state: Tianjin
city: Tianjin
country: China
facility: First Affiliated Hospital of Tianjin University of Chinese Medicine
state: Tianjin
city: Wenzhou
country: China
facility: Wenzhou Chinese Medicine Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Chinese Medicine Hospital
Study officials:
affiliation: The First Affliated Hospital,Heilongjiang University of Chinese Medicine
name: Xiaoke Wu, MD.PhD.
role: STUDY_CHAIR
References: