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Completed

NCT Number: NCT01449396

Acupuncture, Chinese Traditional Medicine, in Embryo Transfer

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.

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Key information

Conditions

Pregnancy

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Reproduction Unit of the University and Politechnic Hospital La Fe.

Valencia, 46026, Spain

About this study

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 Published studies show very different designs and inconclusive/contradictory results can be withdrawn making very difficult to take the clinical decision of recommending acupuncture or not to in vitro fertilization (IVF) patients.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bed Rest

Other

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

Acupuncture

Procedure

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

Primary outcomes

  1. Pregnancy rate

    Time frame: 14 days after embryo transfer

    Heart beating in intrauterus embryo

Secondary outcomes

  1. Rating preconceived ideas about acupuncture

    Time frame: From 24 hours (h) to 14 days after embryo transfer

    Rating preconceived ideas about acupuncture

  2. Determination of serum prolactin and 24h urine cortisol.

    Time frame: 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.

  3. Endometrial vascularization study

    Time frame: 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

  4. Analysis of the results of assisted reproductive cycle

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Oct 10, 2011
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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