The Effect of Acupuncture on Pregnancy Rates in Women Undergoing in Vitro Fertilization With Preimplantation Genetic Screening
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|ClinicalTrials.gov Identifier: NCT03981120|
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility Aneuploidy||Procedure: Laser and Traditional Acupuncture||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Participants will be assigned a computer generated code to be used on data collection forms.|
|Official Title:||The Effect of Acupuncture on in Vitro Fertilization Outcomes in Women Undergoing Euploid Embryo Transfer - A Pilot Study|
|Estimated Study Start Date :||September 15, 2019|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
No Intervention: Standard Care Group
Patients in the control arm will not undergo laser and acupuncture treatment. The treatment and control group will be compared to the baseline pregnancy rate of women meeting the same inclusion and exclusion criteria from the clinic through a chart review over the two years prior to initiation of the study.
Experimental: Laser and Acupuncture Group
The patients in the treatment arm will have 7 treatments before transfer (2-4 sessions a week), for the 3 weeks from starting estrace leading to the day before embryo transfer, then one (before and after transfer) on the day of transfer (total 8 sessions). Each treatment leading up to transfer day treatment consists of:
On the day of FET on site at IVF clinic there will be a before and after traditional and laser acupuncture treatment.
Procedure: Laser and Traditional Acupuncture
Acupuncture (traditional and laser) and photobiomodulation will be performed by a certified acupuncturist on-site with experience in reproductive health and the initial visit will include an assessment and traditional Chinese medicine (TCM) diagnosis.
- Overall Pregnancy Rate [ Time Frame: From date of embryo transfer until the date of first documented pregnancy, whichever comes first, up to 12 months ]Pregnancy beyond 10 weeks' gestation
- Biochemical Pregnancy Rate [ Time Frame: From date of embryo transfer until the date of first documented biochemical pregnancy, whichever comes first, up to 12 months ]positive human chorionic gonadotropin (hCG) serum or urine test > or = 11 days after embryo transfer
- Cumulative Pregnancy Rate [ Time Frame: From date of embryo transfer until the date of first documented intrauterine pregnancy, whichever comes first, up to 12 months ]Presence of at least one intrauterine gestational sac or fetal heartbeat confirmed by ultrasound 4-6 weeks after embryo transfer
- Live Birth Rate [ Time Frame: From date of embryo transfer until the date of birth, whichever comes first, up to 12 months ]Baby born alive after 24 weeks gestation
- Rate of miscarriage [ Time Frame: From date of embryo transfer until diagnosis, up to 12 months. ]Loss of pregnancy
- Rate of adverse events [ Time Frame: Any time during study period up to 12 months ]Any unfavourable outcome from medication or procedures.