Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

Pregnancy Clinical Trial

Official title:

Chinese Traditional Medicine Contribution to Improve In-vitro Fertilization (IVF) Results: Acupuncture in Embryo Transfer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449396
• Other study ID #: ACU2010
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: March 6, 2018
• Start date: October 2011
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to prove that acupuncture applied before and after embryo transfer is able to increase pregnancy rates by means of reducing stress and improving endometrial vascularization in women receiving in vitro Fertilization (IVF) treatments.

Description:

Around 75% of all in vitro fertilization (IVF) treatments fail in providing a healthy baby at home. Most of the women undergoing those techniques suffer in some extent anxiety, depression and stress. Stress make IVF results worse and it has been prove by correlating cortisol, adrenaline and noradrenaline levels with failed cycles. Acupuncture has proved its ability to reduce stress levels. Moreover, Acupuncture has prove to have an effect inhibitory on the sympathetic system and this capacity improves vascularization in uterus and ovaries. Available literature concerning these two issues is not conclusive because of studies design. Acupuncture´s biological mechanism on controlled ovarian stimulation and embryo transfer has not been completely described; if it really has one. Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients. If acupuncture really enhance pregnancy rates in IVF cycles still unanswered given that no randomized three arms study comparing no intervention to sham acupuncture to acupuncture has been published.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: March 2018
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

• 18 to 37 years old

• 18-28 Body mass index (BMI)

• Medical indication of intracytoplasmic sperm injection (ICSI) treatment to treat sterility

• No previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatments

• No previous experience of acupuncture treatments

• At least one high quality embryo in the day of uterine transfer

Exclusion Criteria:

• Polycystic ovarian syndrome

• Endometriosis

• Reproductive surgeries: any on uterus, fallopian tubes or ovaries

• Ovarian cysts >20mm at the beginning of the stimulation cycle

• Hormone treatment in the previous three months of the stimulation cycle, including oral contraceptives

• Previous miscarriages and ectopic pregnancies

• Coasting

• Oestradiol levels >3500pg/ml or ovarian size >65mm in human chorio gonadotropin (hCG) day.

• Failure to keep confidentiality

• Concomitant illness or severe adverse reaction

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Bed Rest
Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer

Procedure:
• Acupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
• Acupuncture
Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer

Locations

Country	Name	City	State
Spain	Human Reproduction Unit of the University and Politechnic Hospital La Fe.	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (23)

15.- Criddenda D, Magarelli P, Cohen M. Acupuncture and in vitro fertilization: does the number of treatments impact reproductive outcomes? Society for Acupuncture Research 2005.

Benson M, ElKind-Hirsch K, Theall A, Fong K, Hogan R, Scott R. Impact of the acupuncture before and after embryo transfer on the outcome of in vitro fertilization cycles: a prospective single blind randomised

Cheong YC, Hung Yu Ng E, Ledger WL. Acupuncture and assisted conception. Cochrane Database Syst Rev 2008; 4: CD006920. study. Fertil Steril 2006; 86 (Suppl2): S135.

Craig L, Criniti A, Hansen K, Marshall L, Soules M. Acupuncture lowers pregnancy rates when performed before and after embryo transfer. Fertil Steril 2007; 88 (Suppl 1): S40.

Dieterle S, Ying G, Hatzmann W, Neuer A. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertil Steril. 2006 May;85(5):1347-51. Epub 2006 Apr 17. — View Citation

Domar A, Meshay I, Kelliher J, Wang S, Alper M. The impact of acupuncture on IVF outcome. Fertil Steril 2006; 86 (Suppl 2): S378-9.

Dong J. Research on the reduction of anxiety and depression with acupuncture. Am J Acupunct 1993; 21: 327-30.

El-Toukhy T, Sunkara SK, Khairy M, Dyer R, Khalaf Y, Coomarasamy A. A systematic review and meta-analysis of acupuncture in in vitro fertilisation. BJOG. 2008 Sep;115(10):1203-13. doi: 10.1111/j.1471-0528.2008.01838.x. Epub 2008 Jul 23. Review. — View Citation

Magarelli ´P, Cohen M, Criddenda D. Acupuncture and good prognosis IVF patients: synergy. Fertil Steril 2004; 82: S80-1.

Magarelli P, Cohen M, Criddenda D. Acupuncture: impact on pregnancy outcomes in IVF patients. 12th World Congress on Human Reproduction, Venice, Italy, March 2005.

Magarelli P, Cohen M, Criddenda D. Improvement of IVF outcomes by acupuncture: are egg and embryo qualities involved? Fertil Steril 2005; 83: S9.

Magarelli P, Criddenda D, Cohen M. Proposed mechanism of action of acupuncture on IVF outcomes. Fertil Steril 2006; 86: S174-5.

Magarelli P, Criddenda D, Cohen M. The demographics of acupuncture´s impact on IVF outcomes: infertility diagnosis and SART/CDC/age groups. Fdertil Steril 2007; 87: S10-1.

Magarelli P, Criddenda D. Acupuncture and IVF poor responders: a cure? Fertil Steril 2004; 81: S20.

Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. BMJ. 2008 Mar 8;336(7643):545-9. doi: 10.1136/bmj.39471.430451.BE. Epub 2008 Feb 7. Review. — View Citation

Ng EH, So WS, Gao J, Wong YY, Ho PC. The role of acupuncture in the management of subfertility. Fertil Steril. 2008 Jul;90(1):1-13. doi: 10.1016/j.fertnstert.2008.02.094. Epub 2008 Apr 28. Review. — View Citation

Paulus E, Zhang M Strehler E, Sterzik K. Motility of the endometrium after acupuncture treatment. Fertil Steril 2003; 80 (Suppl 3): 131.

Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil Steril. 2002 Apr;77(4):721-4. — View Citation

Smith C, Coyle M, Norman RJ. Influence of acupuncture stimulation on pregnancy rates for women undergoing embryo transfer. Fertil Steril. 2006 May;85(5):1352-8. Epub 2006 Apr 5. — View Citation

So EW, Ng EH, Wong YY, Lau EY, Yeung WS, Ho PC. A randomized double blind comparison of real and placebo acupuncture in IVF treatment. Hum Reprod. 2009 Feb;24(2):341-8. doi: 10.1093/humrep/den380. Epub 2008 Oct 21. — View Citation

Stener-Victorin E, Waldenström U, Andersson SA, Wikland M. Reduction of blood flow impedance in the uterine arteries of infertile women with electro-acupuncture. Hum Reprod. 1996 Jun;11(6):1314-7. — View Citation

Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertil Steril. 2006 May;85(5):1341-6. Epub 2006 Apr 5. — View Citation

White AR. A review of controlled trials of acupuncture for women's reproductive health care. J Fam Plann Reprod Health Care. 2003 Oct;29(4):233-6. Review. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Heart beating in intrauterus embryo	14 days after embryo transfer
Secondary	Rating preconceived ideas about acupuncture	Rating preconceived ideas about acupuncture	From 24 hours (h) to 14 days after embryo transfer
Secondary	Determination of serum prolactin and 24h urine cortisol.	Determination of serum prolactin and 24h urine cortisol to measure stress levels on the day of embryo transfer.	The day of embryo transfer (+14 days post-cycle start)).
Secondary	Endometrial vascularization study	Endometrial vascularization study on the day of embryo transfer, 2 days before and after it	The day of embryo transfer (+14 days after cycle start) and 2 days before and after it.
Secondary	Analysis of the results of assisted reproductive cycle	Analysis of the results of assisted reproductive cycle on levels of beta human chorionic gonadotropin (BhCG) +14 days post-transfer, evidence of intrauterine gestational sac with heartbeat and embryo live birth at home	After 14 days post-transfer (28 days after cycle star)