None listed
Conditions
Brief summary
The aim of this study is to examine whether the use of acupuncture improves the characteristics of the endometrium associated with implantation and pregnancy. Women will be randomised to receive acupuncture or standard care (control group). Women will be randomised at day 9 subject to the result of ultrasound and blood test. The endometrium will be assessed by vaginal ultrasound and the endometrium thickness and pattern recorded. The ultrasound will be performed by a fertility specialists blind to the study group (routine scan) at day nine to assess timing for egg retrieval. Further ultrasound measurements will be undertaken at the time of Embryo Transfer (ET) and an extra ultrasound undertaken one week following egg retrieval. Routine bloods will be taken prior to egg retrieval and additional blood will be taken on day seven following egg retrieval. Routine measurement of plasma oestradiol and progesterone will be taken. Study group : Treatment with acupuncture Acupuncture points to be used will be selected according to the individual Traditional Chinese Medicine (TCM) diagnosis, and at the time of the first treatment. The second treatment will be administered 25 minutes prior to embryo transfer. Classical acupuncture points pericardium 6 (PC6), Spleen 8 (SP8), Liver 3 (LR3), Stomach 29 (ST29), and Conception vessel (CV4) will be used. Auricular acupuncture points Shenmen, Zhigong, Neifenmi and Naodian will also be used. The third treatment will be administered 25 minutes after embryo transfer using acupuncture points Stomach 36 (ST36), Spleen 6 (SP6), and Spleen 10 (SP10). Auricular points Shenmen, Zhigong, Neifenmi and Naodian will be also be needled. Seirin acupuncture needles will be inserted to tissue level and stimulated manually to elicit the Deqi response. Needles will be retained for 25 minutes in each treatment. Study group 2: Standard care The standard treatment protocols for In Vitro Fertilization (IVF) and embryo transfer will be followed.
Interventions
Acupuncture versus standard care.
Women allocated to the acupuncture group will receive three treatments of acupuncture. The first treatment will be administered two days prior to egg harvest and two treatments will be administered on the day of the embryo transfer immediately before and after transfer. The first acupuncture treatment will be administered based on the traditional Chinese medicine diagnosis. The treatments administered at embryo transfer will be following the protocol used by
Acupuncture versus standard care. Women allocated to the acupuncture group will receive three treatments of acupuncture. The first treatment will be administered two days prior to egg harvest and two treatments will be administered on the day of the embryo transfer immediately before and after transfer. The first acupuncture treatment will be administered based on the traditional Chinese medicine diagnosis. The treatments administered at embryo transfer will be following the protocol used by Smith and colleagues in previous research. This protocol is as follows Study group : Treatment with acupuncture Acupuncture points to be used will be selected according to the individual Chinese medicine diagnosis, and at the time of the first treatment. The second treatment will be administered 25 minutes prior to embryo transfer. Classical acupuncture points pericardium 6 (PC6), Spleen 8 (SP8), Liver 3 (LR3), Stomach 29 (ST29), and Conception vessel (CV4) will be used. Auricular acupuncture points Shenmen, Zhigong, Neifenmi and Naodian will also be used. The third treatment will be administered 25 minutes after embryo transfer using acupuncture points Stomach 36 (ST36), Spleen 6 (SP6), and Spleen 10 (SP10). Auricular points Shenmen, Zhigong, Neifenmi and Naodian will be also be needled. Seirin acupuncture needles will be inserted to tissue level and stimulated manually to elicit the Deqi response. Needles will be retained for 25 minutes in each treatment. Study group 2: Standard care The standard treatment protocols for In Vitro Fertilisation and embryo transfer will be followed. All women will have an ultrasound to assess the thickness of the endometrium and pattern at day 9. Further ultrasound measurements will be made at the time of the embryo transfer and one week following egg harvest (day 16). Routine bloods will be taken prior to egg harvest and additional blood will be taken one week following egg harvest. The trial will run for six months.
Sponsors
Discipline Obstetrics and Gynaecology, School of Paediatrics and Reproductive Health, University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Undergoing (fresh natural and stimulated cycle) embryo transfer at day 3.
Exclusion criteria
Undergoing a frozen cycle.
Outcome results
None listed