Clinical trial NCT04645745: Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS
Official title: Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Myo-inositol
alpha-lactalbumin
HOMA-index
ovulation
hyperandrogenism
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
Collaborators: name: Hospital Juarez de Mexico
First posted: 2020-11-27
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.

Detailed description: This is an open-label clinical trial aimed at evaluating and comparing the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of PCOS patients from the Mexican and Italian population. The addition of alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and consequently improve its effect. The scientific evidence so far available shows that these two groups of PCOS women have a different genetic, nutritional, and behavioural profile. Important factors are body mass index and insulin resistance, both increased in the Mexican women, although among them PCOS prevalence is not higher compared to many other populations. Therefore, the focus of this study is to check the effects of the combined administration of myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to compare these effects between the two groups of patients, monitoring several hormonal parameters connected to the menstrual cycle regularization.

Eligibility criteria: Inclusion Criteria:

* PCOS diagnosis based on the Rotterdam ESHRE-ASRM consensus workshop group1.
* Presence of Insulin resistance diagnosed by HOMA-Index
* Patients belonging to the Mexican population
* Patients belonging to the Italian population

Exclusion Criteria:

* BMI ≥ 30
* Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome
* Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation
* Drastic changes in diet and physical activity
* Treatment with products containing inositols in the previous 3 months

Primary outcomes:
measure: Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
timeFrame: three and six months
Secondary outcomes:
measure: Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
timeFrame: three and six months
measure: Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism
timeFrame: three and six months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: AGUNCO Centre
city: Ciudad de México
country: Mexico
facility: Hospital Juarez de México
Study officials:
References: