Electro-acupuncture and Assisted Reproductive Technology
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Electro-acupuncture and Assisted Reproductive Technology: Impact of EA on Endometrium During Medicated Frozen Embryo Transfer Uterine Preparation|
- Change in endometrium thickness during hormone treatment [ Time Frame: Baseline, day 8 and day 15 of hormone treatment ] [ Designated as safety issue: No ]As part of the preparation for embryo transfer, patients undergo ultrasound during hormone treatment to assess endometrium thickness. Research participants will agree to release ultrasound results to the research personnel to determine whether acupuncture treatments affect endometrium thickness compared to no acupuncture treatment.
|Study Start Date:||November 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Electro-Acupuncture
Group will receive 4 acupuncture treatments over 14 days during hormone treatment
Procedure: Acupuncture, Electro-Acupuncture
Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.
No Intervention: Control
Group will not receive acupuncture.
All the subjects in the study will be randomized and their participation is completely voluntary. Patients recruited to join the study will not receive any monetary compensation for participation.
This research will include 100 female subjects, ages 21-45, undergoing medicated frozen embryo transfer (mFET). The subjects will be randomized into treatment and the non-treatment groups. The non-treatment group will undergo the medicated uterine preparation for FET according to the fertility clinic's protocol.
Subjects in the treatment group will receive four electro-acupuncture (EA) treatments in addition to the mFET protocol, starting after the 1st Ultrasound measurement which constitutes as a baseline, until the start of the progesterone administration. Endometrial thickness will be measured using ultrasound and estrogen (E2) levels will be measured by blood samples as a standard measure to assess the time of P4 (progesterone) supplementation. This step will be done by the participant's fertility clinic according to the clinic's protocol.
Acupuncture points of LI-4, LV-3, SP-6, Zi Gong, CV-3, CV-4, ST-36 will be needled. Electro-stimulation will be applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4 at low frequency. The needle retention with electro-stimulation will last for 25 minutes. After the 25 minutes, the needles and the electro-stimulation will be removed and the patients will be dismissed.
Ultrasound results measuring endometrium will be obtained from the subject's fertility clinic. US and bloodwork will be performed at baseline, and before the progesterone administration according to the fertility clinic. This US measurement and bloodwork results will be used for statistical analysis to compare endometrial lining of the two groups. The final discussion will be presented according to the findings.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481090
|United States, Illinois|
|Tiffani Kim Institute|
|Chicago, Illinois, United States, 60654|
|National University of Health Sciences|
|Lombard, Illinois, United States, 60148|
|Principal Investigator:||Hui Y Cai, Ph.D||National University of Health Sciences|