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Metformin

Laparoscopic sleeve gastrectomy on severe obesity PCOS patients

Tao Tao, MD

Yuchen Zhu, Master

Tao Tao, Doctor

This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring.

The investigators designed a single center small sample exploratory study to clear the therapeutic effects of laparoscopic sleeve gastrectomy on live birth rate improvements of overweight/obese PCOS patients. The investigators plan to enroll 18 patients. Inclusion criteria: 1) Patients who are aged from 18 to 45, not menopause;2) have PCOS which is diagnosed according to 2003 Rotterdam criteria; 3) have been treated with behavioral and drugs intervention for 3 months but are ineffective; 4) have steady or steady weight gain over 5 years, BMI\>35kg/m2, or BMI\>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome.

Patients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (\>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; surgical contraindications are excluded.

Then the investigators plan to perform laparoscopic sleeve gastrectomy . Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients are followed up every 3 months until the end of the program. All patients receive MRI plain scan of upper and lower abdomen, oral glucose tolerance test (OGTT) and insulin, C-peptide releasing test again every 6 months after the operation. One year after the operation, patients would be evaluated whether they are suitable for pregnancy preparation and record the pregnancy mode. After pregnancy, various indicators would be closely monitored, including maternal vitamin and trace element levels.The birth of children and the live birth rate would be recorded.

The investigators will compare the data and finally identify the treatment effect of laparoscopic sleeve gastrectomy on overweight/obese PCOS patients.

Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients

Effect of Laparoscopic Sleeve Gastrectomy (LSG) on Live Birth Rate of Offspring in Polycystic Ovarian Syndrome (PCOS) Patients With Severely Obese

To record the offspring production and live birth rate of obesity PCOS patients after metabolic surgery

To compare the ovulation rate and pregnancy of obesity PCOS patient with metabolic surgery or not

To compare the intestinal flora of PCOS patients after metabolic surgery

RenJi Hospital

Infertility

Infertility, Female

Abortion, Spontaneous

Micronutrients

Hematinics

Vitamins

Other Dietary Supplements

Inositol

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Couples with PCOS infertile women, diagnosed according to the Rotterdam criteria, who access infertility center with conception desire. These women will receive oral supplementation with Inositol (Myo-inositol and D-chiro-inositol at 40:1 ratio) plus Folic acid for 6 months.

Couples are required to have regular intercourse with the aim to achieve a spontaneous conception.

Couples with PCOS infertile women, diagnosed according to the Rotterdam criteria, who access infertility center with conception desire. These women will receive oral supplementation with Folic acid for 6 months.

Couples are required to have regular intercourse with the aim to achieve a spontaneous conception.

Daily oral supplementation of for 6 months or until pregnancy conception:

Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg

Inositol + Folic acid

Daily oral supplementation of for 6 months:

Folic acid: 400 mcg

Folic acid

Couples are required to have regular intercourses with the aim to achieve a spontaneous conception.

Regular intercourses

Antonio Simone Laganà, M.D.

Simone Garzon, M.D.

Fabio Ghezzi, M.D.

Massimo Franchi, M.D.

Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS.

Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited.

Conversely, about infertility and assisted reproduction techniques (ART), improvements have been reported in PCOS women who underwent fertility treatment using inositol in different forms, combinations or doses. This data, considering the different tissue-specific ratios (i.e., 100:1 in the ovary) and the different physiological roles of inositol stereoisomers, suggest that DCI supplementation alone might not be the optimal or appropriate approach for improving IVF outcomes in PCOS patients, and drawn attention to the importance of MI and DCI supplementation in a physiological ratio in order to restore normal ovary functionality. Indeed, the combination of MI and DCI, at a more physiological ratio of 40:1, was able to more quickly restore to normal the hormonal and metabolic parameters in PCOS women than MI treatment alone or DCI treatment alone, improving the endocrine profile and IR of women with PCOS.

Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in ART in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies.

Randomized multi centre double-blind controlled trial

The patients, care provides, investigators and outcome assessors are blinded for the treatment: Inositol + Folic acid versus Folic acid alone. The treatment allocation is identified by code number before the study start, and will be revealed only after data analysis.

Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women.

Effects of Oral Inositol Supplementation on Spontaneous Reproductive Outcomes in Infertile Polycystic Ovarian Syndrome Women.

Number of spontaneous pregnancies conceived per women diagnosed by transvaginal ultrasound. Diagnosis is based on the identification of intrauterine gestational sac with embryo and/or yolk sac.

Number of spontaneous abortion per women diagnosed by positive pregnancy test with subsequent spontaneous interruption of the pregnancy.

Number of spontaneous pregnancies per women resulted in a delivered viable fetus.

Spontaneous ovulation activity evaluated by menstrual cycle regularization. Menstrual cycles evaluated by intervals between menstruations (days), day of menstrual blood flow. Rate evaluate considering the number of women with restored regular menstrual cycles per women with irregular menstrual cycles.

OGTT: values of oral glucose tolerance test. Impaired glucose metabolism is diagnosed if fasting glucose values were abnormal (100-125 mg/dl) or glucose tolerance is impaired (2 h plasma glucose within OGTT range of 140-199 mg/dl), and when glucose values exceed threshold values for gestational diabetes (fasting glu- cose value ≥92mg/dl, 1-hour glucose value ≥180mg/dl or 2- hour glucose value ≥153mg/dl)

Lipid profile assessed by evaluation the high density lipoprotein level and triglycerides level.

Serum free testosterone, dehydroepiandrosterone sulfate, and serum SHBG serum concentrations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients	NCT04151459	Polycystic Ovar... Severe Obesity Laparoscopic Sl...	Metformin	18 Years - 45 Years	RenJi Hospital
Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women.	NCT03598374	Polycystic Ovar... Infertility, Fe...	Inositol + Foli... Folic acid Regular interco...	18 Years - 40 Years	Università degli Studi dell'Insubria
Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients	NCT04151459	Polycystic Ovar... Severe Obesity Laparoscopic Sl...	Metformin	18 Years - 45 Years	RenJi Hospital

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