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Induction of Ovulation clinical trials

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NCT ID: NCT04887402 Recruiting - PCO Clinical Trials

Parameters Declaring PCO Infertile Patients Either Sensitive or Resistant to Different Doses of Clomiphene Citrate.

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Polycystic ovary syndrome (PCOS) is a common endocrinological disorder seen in 6%-10% of women (Human Reproduction, 2004). It is characterized by polycystic ovaries, anovulatory cycles, and hyperandrogenism. In nearly 20% of infertile women, PCOS is said to be the key reason behind infertility (Norman et al., 2007). PCOS is a syndrome that manifests variably from adolescence as oligomenorrhea or hirsutism or obesity and goes on to affect the reproductive performance of the female by causing anovulation. Some may even be severely affected by metabolic syndrome, diabetes mellitus, or endometrial carcinoma. It also increases the risk of ovarian and breast carcinoma (Atiomo et al., 2003). PCOS falls in WHO type II anovulation (norm-gonadotropic norm-estrogenic anovulation) and is seen in 85% of anovulatory females. Although lifestyle modification is known to improve reproductive outcomes in females with PCOS, the gold standard treatment for norm-gonadotropic oligo/amenorrheic infertility (WHO Group II) was clomiphene citrate (CC) (Radosh L., 2009) until 2018, when ESHRE and ASRM have declared letrozole as the first-line treatment for ovulation induction (OI)( ESHRE 2018 guidelines). To conclude, available data shows that letrozole is at least as effective as CC for ovulation and has comparable live birth rates. Importantly, it has definite advantages over CC. Many studies have shown letrozole to be as effective as gonadotropins, with added advantage of low cost and lower multiple pregnancy rates. However, the quality of medical evidence supporting aromatase inhibitors for OI, are inadequate, small in sample size, and inappropriate design. Moreover, there is very limited data on potential teratogenic effects, oocyte, embryo quality, and any effect on implantation. ( Misso et al., 2012) Those who fail to respond to CC are labeled as clomiphene resistant. It is common in approximately 15%-40% of women with PCOS (NICE, 2014). Major factors postulated for CC resistance include obesity, insulin resistance, (seen in nearly 50%-70% of females with PCOS) and hyperandrogenemia (Parsanezhad et al., 2001).Moreover, genetic predisposition is suggested to play a role in CC resistance (Overbeek et al., 2009).However, still, the current data available on the causes of CC resistance are not sufficient enough to direct our treatment. It is seen in various studies (Sohrevardi et al.,2016) that the females who initially failed to respond to CC develop better ovulation and pregnancy outcomes on treatment with insulin-sensitizing agents. This indicates that insulin resistance may be a cause of CC resistance in females with PCOS. In fact, insulin-sensitizing agents (Azziz et al., 2009) decrease the dose of ovulation-inducing agent and time for follicular maturation in females with PCOS. As of now, there have been no concrete studies to compare the metabolic profile of females who respond to CC and those who do not. It is still an enigma as to why some women respond to clomiphene, while others do not. By identifying the various factors which affect the response of CC in patients with infertility, a lot of time can be saved by giving alternate options of treatment to these patients. This study was done with the aim to analyze various clinical, metabolic, hormonal, and ultrasound parameters that might affect the response to clomiphene.

NCT ID: NCT03664050 Recruiting - Clinical trials for Induction of Ovulation

Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).

NCT ID: NCT01851512 Completed - Infertility Clinical Trials

A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803

Start date: May 2010
Phase: Phase 1
Study type: Interventional

This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.