Overview

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

Status:
Not yet recruiting
Trial end date:
2023-10-30
Target enrollment:
Participant gender:
Summary
The large number of women in their child bearing age is affected by Polycystic ovarian syndrome (PCOS) leading to infertility. However it is considered as a multisystem disorder with comorbidities rather than a gynecological and a dermatological problem. Patient mostly have anovulation presented as oligomennorhea or amenorrhea and hyperandrogenism presented as hirsutism along with hyperinsulinemia and insulin resistance. The presence of multiple cysts in the ovaries is not essential for diagnosis. Many etiological factors are reported but those actually responsible for PCOS in females still need to be explored. However hyperandrogenism and insulin resistance being the key triggering condition apart from cardiovascular disease, type 2 diabetes, hypertension and obesity. Nearly 100 million women are effected with this disease worldwide. World Health Organization (WHO) has considered Infertilty as public health problem. it was the objective of UN conference 2015 to provide access and quality reproductive health services to all individuals. About 50 to 80% women having PCOS are obese. Researchers reported the obesity role in occurrence of PCOS and its Infertilty relation . Poly cystic ovary syndrome is not a simple pathophysiologic process for which one treatment address all manifestation. Treatment should target specific manifestations and individualized patient goals. When choosing a treatment regimen, physicians must take into account comorbidities and the patient's desire for pregnancy. First-line agents for ovulation induction and treatment of infertility in patients with PCOS include metformin and clomiphene alone or in combination. It has been approved as category "A "to regulate ovulation and improves pregnancy rates in women with PCOS . Mostly it result in complication like multiple follicle recruitment rate, multiple pregnancy and thining of endometrial wall leading to early abortion and endometrial cancers.The use of naturally occurring compounds like myoinositol, D-chiro- inositol and L- carnitine which are already part of human body are expected to produce significant results without any side effects . The proposed study will provide an alternative to current treatments available for infertility due to PCOS. The expected project execution time is 1 years. Thus, the present project will discover new insights about treatment of infertilty and thus generate new knowledge which will help Academia, scientists and health care professionals. Moreover, the proposed project involves, "the formulation of new drugs" which can be patent and may benefit Pharmaceutical industry of Pakistan as well. Results of the study will be disseminated on different forums including to policy makers , Pharmaceutical, national and international agencies. The result will be published in journal both national and international with good impact factors. The outcome of the project will be used as publication in high impact international journals, filling of patents and will also be presented in national and international forums.
Phase:
N/A
Details
Lead Sponsor:
Khyber Medical University Peshawar
Collaborator:
University of Cagliari
Treatments:
Acetylcarnitine
Inositol
Metformin