Pregnancy
Conditions
Keywords
acupuncture, in vitro fertilization, embryo transfer
Brief 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.
Detailed 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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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.
Interventions
OTHERBed Rest
Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
PROCEDUREAcupuncture
Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 14 days after embryo transfer | Heart beating in intrauterus embryo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rating preconceived ideas about acupuncture | From 24 hours (h) to 14 days after embryo transfer | Rating preconceived ideas about acupuncture |
| Determination of serum prolactin and 24h urine cortisol. | The day of embryo transfer (+14 days post-cycle start)). | Determination of serum prolactin and 24h urine cortisol to measure stress levels on the day of embryo transfer. |
| Endometrial vascularization study | The day of embryo transfer (+14 days after cycle start) and 2 days before and after it. | Endometrial vascularization study on the day of embryo transfer, 2 days before and after it |
| Analysis of the results of assisted reproductive cycle | After 14 days post-transfer (28 days after cycle star) | 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 |
Countries
Spain
Outcome results
None listed