RESEARCH

Although results from two earlier studies show great promise, they were neither published nor statistically tested. Therefore The Aviva Method Center is now committed to promote the method scientifically. Together with IVF Unit at one of Israel's known Medical Center, the Aviva Method Center is starting a controlled clinical research to test the efficacy of the Aviva method in the treatment of fertility problems. The specific aim of the study is to test the response of IVF patients, diagnosed as poor responders, to the Aviva Method exercise sequence.

Research proposal

The efficacy of the Aviva Method among “poor responder” women in IVF unit: A Before-After Pilot Study

A- Background

1- “Poor responders”

Women’s optimal fertility period occurs between 18 and 31 years. In the early thirties, oocytes quality and number of follicles gradually start to decrease, until menopause. In about 10% of women, this process occurs prematurely, the ovarian reserve is diminished despite the young age (before 40), and the chance of achieving a spontaneous pregnancy is low. The mechanism involved in premature ovarian insufficiency is still not fully understood. Furthermore, for social reasons, some women deliberately decide to delay pregnancy after the age of 40, thus trying to get pregnant when their ovarian reserve is low. More and more women from these two categories are seeking infertility treatments, making the issue of diminished ovarian reserve more and more important in IVF units.

In Poor ovarian response IVF patients, despite the hormonal stimulation, few oocytes are retrieved. Consequently, few embryos can be selected for transfer, and pregnancy rates per transfer are lower compared to other IVF patients. Because of the variability in the definition of this condition, its incidence is poorly estimated (between 9% and 24% of what?). The most common definition for a “poor responder” is the presence of at least two of the following features: a) advanced maternal age or any other risk factor for poor ovarian response, b) a previous poor ovarian response, and c) an abnormal ovarian reserve test.

2- Aviva Method for treatment of infertility

The Aviva method is a structured physical exercise technique that is aimed to improve fertility, regulate the female menstrual cycle and relieve menopause symptoms. Based on methodical movement sequences principally acting on female reproductive organs (ref), this method helps infertile women with high Follicular Stimulating Hormone (FSH) levels to achieve hormonal balance, thereby improving ovulation pattern. The Aviva method is also effective in achieving spontaneous pregnancy among women who suffer from Polycystic Ovaries Syndrome, or from unexplained infertility. Recently, The Aviva method has started to be used as a complementary method for women before and during in vitro fertilization cycles (ref). We have data on 5 IVF patients that, after three months of Aviva Method training, have seen an improvement in the number and quality of oocytes and embryos for transfer, compared to their previous IVF cycles.

Several hypotheses may explain the Aviva Method's success and effectiveness among infertile women. One of these hypothesis is related to the psychological well-being of the patients. High levels of physiological stress are associated with a longer time-to-pregnancy (TTP) and an increased risk of infertility. By using the Aviva method, the regular physical activity and emotional support from the teacher may act as stress reducers and improve mental and psychological wellness.

Another hypothesis postulates that the repetitive exercise sequences focused on the pelvic area may reinforce the blood flow to the ovaries and the uterus, thus strengthening the whole female reproductive system. Adequate ovarian blood flow is an important precondition for normal physiological ovarian function. badly oxygenated oocytes are are more likely to be chromosomal imbalanced, and less likely to develop into pregnancy . Moreover, ovarian and uterine artery blood flow velocities play an important role in implantation success during the IVF treatment.

A third hypothesis tends to explain the physiological effect of the Aviva method by the beta-endorphin regulation, which affects Gonadotrophin Releasing Hormone secretion, and then Luteinizing Hormone release before ovulation. In the context of poor ovarian response, the hypothesis of increased blood flow may be the most relevant one: the increased blood flow to the ovaries and to the uterus may act as a booster for reproductive organ function, thus increasing the chance of IVF cycle success

3- Why this study?

Despite the improvement of the IVF techniques, there is still no efficient treatment specified for poor ovarian response. Complementary medicine is especially promising in cases where conventional medicine reaches its limits, “poor responders” being one of these cases. In Israel, 40% of the IVF patients are using complementary medicine for fertility purpose.

The present study is the first clinical trial involving the Aviva Method as a complementary method for treatment of infertility by assisted reproductive technology. As the method is just starting to be used in IVF patients, we have data of only 5 IVF patients that used Aviva Method for fertility improvement. All of them have seen a promising improvement in the number and quality of oocytes and embryos. In the context of evidence-based medicine, our purpose is to assess the efficacy of Aviva Method for the improvement of IVF outcomes among “poor responders” women treated in the IVF unit at one of Israel's known Medical Center.

B- Objectives of the study

  1. to assess the effect of the Aviva Method on IVF treatment response among “poor responder” women treated in IVF unit.
  2. to assess the Aviva method effect on uterine and ovarian blood flow velocity, the following parameters will be measured in the pilot study:

Primary outcome: The treatment response is composed of:

Secondary outcomes:

C- Design of the study

1- Study population

Inclusion criteria: For this pilot study, women under age 40 which are treated in the IVF Unit will be recruited, with FSH levels above 16 IU/mL, and which are diagnosed as “poor responders” (in this study this definition will pertain to: less than 5 oocytes retrieved in the precedent IVF cycle, more than 2 IVF cycles without pregnancy). Finally, only women which will provide a written informed consent will be included in this study.

Non-inclusion criteria: Women with previous surgery in reproductive organs (uterus, ovaries and Fallopian tubes), women with inherited disorders (Turner Syndrome, Fragile X Syndrome), women with BMI above 30, women with psychiatric disorders or physical handicap will not be able to participate in this study. In addition, women who used complementary methods for fertility improvement in the six months prior to the onset of this pilot study, such as acupuncture, yoga, reflexology and others, will not be included.

2- Sample size estimation

Since there is no previously-reported study of the Aviva Method, it was not possible to either: (i) predict with any level of accuracy the level of IVF treatment response; and (ii) calculate the minimum statistically significant sample size. This is the reason why we decided to preliminary check our hypothesis in a small pilot study of 15 women.

3- Data collection and analysis

Statistical analysis will be performed using the SPSS statistical software (version 21). We will first collect general characteristics of all the participants. IVF outcomes will be collected in the first and also in the second IVF cycle after beginning of the Aviva Method training, and will be compared to the outcomes of the cycle before training (baseline outcomes). Categorical outcomes (clinical pregnancy) before and after Aviva Method training will be compared, using MacNemar Test. For all statistical tests, p-value less than 0.05 will be considered as statistically significant.

4- Enrollment of subjects

The enrollment will take place at the IVF Unit. The fertility physicians of the unit will propose to all their “poor responder” patients to be a part of this pilot study. Patients expressing initial interest will be contacted with the Aviva Method coordinator, who will provide them with information on the study. If a patient will be found eligible (according to the above inclusion and non-inclusion criteria), she will be asked by her fertility physician to provide a written informed consent.

5- Intervention

The first step of the treatment is participation of the patient in two lessons, each consisting a two hours lecture, with an interval of a week between lessons. In this course, the participant will learn from a certified Aviva Method teacher the relevant Aviva Method exercises.

The second part of the intervention is an at-home training for six weeks. The participant will be encouraged to practice at home for about 20 minutes three times a week. At the end of this home-training period, the participant will start a new IVF cycle.

From the beginning of the hormonal stimulation until embryo transfer, the participant will be asked to change the training program, according to the teacher instructions (a restricted training of about 10 minutes every day).

6- Follow up

Form the beginning of the trial until the end of the practicing period, the participant will be in contact by phone once a week with the Aviva Method teacher, in order to check that she is practicing according to the protocol. The teacher will also ask about potential side effects, and will reinforce motivation to keep on training.

The participant will be also asked to self-report her home training in a diary.

At the end of the training period, the participant will have a medical examination by one of the fertility doctors of the IVF unit.

7- Security control

The Aviva Method teacher will be responsible for adverse event monitoring; if one the participants complains of undesirable side effects during the lesson or by phone, she will automatically inform the Aviva Method coordinator. The coordinator will then inform the principal investigator or the study. The Medical Center ethical committee will then decide about the participant exit from the study, or about early-termination of the whole study.

D- Quality control

Data monitoring

All the data about general characteristics of the participants, and about IVF outcomes, will be collected and analyzed by the IVF unit statistician.

Data about adherence to Aviva Method protocol will be collected by the teachers and analyzed by the Aviva Method coordinator. For each participant, the teacher will be asked to fill in a follow-up form (reporting data on attendance in the two lessons, home training according to the participant report, adherence to protocol, and reporting adverse events) and to transmit the data to the coordinator. Moreover, at the end of the training period, all the participants will be asked to return their home-training diary to the coordinator.

Exclusion criteria

The participant will be excluded from the study if she will be absent from one or both of the frontal lessons, if she will perform less than 70% of the exercises as described in the protocol, or less than twice a week, throughout the training period. The participant will also exit the study if she will fall sick during the training period, and because of that she will not be able to practice physical activity for more than 5 days. If the participant starts any other alternative treatment during the study period, she will also be excluded from the study.

Termination policy

If any serious adverse event is reported by one of the participants, an ethical committee will meet to decide about early-termination of the study.

E- Ethics

The present study will start only after approval of the Institutional Review Board of Medical Center. Only women who will provide a written informed consent will be allowed to participate to the study. The participants will be informed about their legal capacity to discontinue participation at any time of the study, without penalty or loss of benefits.

Confidentiality of the data will be maintained.

Conclusion

Aviva Method is a non-invasive therapy method for the treatment of infertility, and the risk for undesirable side effects is very low. There is no conventional effective treatment for “poor responders” women, and complementary methods show promise in treatment of this condition. Even though the Aviva Method had been used for approximately 40 years for the treatment of infertility, there is no single clinical trial measuring effectiveness. Thus, there is a real need for a randomized controlled study. The present before/after study is a first step, in assessing the feasibility, adherence and efficacy of the Aviva method in infertility conditions, and to assist in determining the appropriate sample size effect for future randomized controlled trials.

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