The Effects of Acetyl L--Carnitine and Myo/Chiro-Inositol on Improving Ovulation, Pregnancy Rate, Ovarian Function and Perceived Stress Response in Patients With PCOS (PCOS)
Infertility, Female, PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
About this trial
This is an interventional supportive care trial for Infertility, Female focused on measuring PCOS, INFERTILTY
Eligibility Criteria
Inclusion Criteria:Married women with PCOS aged ≥18 years to ≤35 years who is infertile (primary and secondary) and have a wish to conceive will be included in the study. The diagnosis of PCOS will be made according to the NIH 2012 extension of ESHRE/ASRM 2003 criteria (21). Identification of specific phenotypes will be included: A. Hyperandrogenism plus Ovulatory dysfunction plus Polycystic Ovarian Morphology (HA +OD+PCOM) B. Hyperandrogenism plus Ovulatory dysfunction (HA+OD) C. Hyperandrogenism plus Poly Cystic Ovarian Morphology (HA+PCOM). D. Ovulatory dysfunction plus Polycystic Ovarian Morphology (OD+PCO) Couple inclusion criteria; Being a sterility trial couples ensuing to do their semen analysis regularly or provide record showing their sperm concentration to be at least 15 million /ml in at least one ejaculation during the past one year with some motile sperm. Similarly, couples having ability and readiness to perform sexual intercourse as and when directed by the investigator will be included. Female subjects should have at least one open fallopian tube and normal uterus from inside on hysterosalpingography /hysteroscopy/laparoscopy or have normal course of conception, delivery during the past 03 years. Patients should have no history of tubal ligation or vasectomy procedure that has been reversed Exclusion Criteria: Females having history of having an infertile male partner in the past, Cushing syndrome, diabetes, thyroid disorders, hyperprolactinemia, ovarian tumors, congenital adrenal hyperplasia, androgen-producing tumors, history of seizures, pregnancy undiagnosed vaginal bleeding History of suspected cervical or endometrial carcinoma breast carcinoma using contraceptive anti-coagulants, antiplatelet, isoproterenol and potassium sparing diuretics, anti-depressants and medications that alters the biochemical or hormonal profile will be excluded. Participants who have been prescribed hormones during the past at least 3 months before the study will not be included in the study. Patient who is willing to participate in the study is using any medicine that can be discontinued (e.g., oral contraceptive or ovulation induction agents (GnRH agonist and antagonist; gonadotropins, HCG) will be allowed wash out period of 02 months before being included in the study. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Metformin Group
Inositol isomers Group
Acetyl-L- Carnitine Group
Combine Group
Metformin will be used in dose of 500mg BD daily for 30 infertile female PCOS patients
Inositols isomers (Myo inositol and D- Chiro Inositol in its physiological ratio) will be used 2000mg BD Daily for 30 infertile female PCOS patients
Acetyl-L-Carnitine will be given in dose of 1000mgBD Daily for 30 infertile female PCOS patients
Inositol isomers and Acetyl-L-Carnitine will be given in dose of 2000mg and 1000mg respectively BD daily for 30 infertile female PCOS patients