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Clomiphene Citrate clinical trials

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NCT ID: NCT05231980 Completed - Clinical trials for Polycystic Ovary Syndrome

Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate

Start date: June 5, 2022
Phase: Phase 2
Study type: Interventional

This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.

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: NCT03309436 Recruiting - Infertility, Female Clinical Trials

Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

Start date: August 7, 2017
Phase: Phase 4
Study type: Interventional

Clomiphene citrate has been widely used for treatment of infertility for decades. Although its anti-estrogenic effects leads to low pregnancy rate, clomiphene citrate is still a first-line treatment for ovulation induction because of its simple usage, low prices, no injection and low risk of ovarian hyperstimulation syndrome. Clomiphene citrate shows high affinity with estrogen receptor, which inhibits endometrial proliferation, inevitably leads to a decline in endometrial receptivity, thus affecting the success rate of IVF. In that case, use clomiphene citrate for ovulation induction is lost more than gained based on fresh embryo transfer. But recently, some researchers have proposed to extend the time from ovulation induction to embryo transfer, and the increased level of estradiol can replace clomiphene citrate to combine with the receptor, so that the uterine environment is more conducive to pregnancy. Therefore, use clomiphene citrate based on vitrification of embryo maybe a good way for treatment of infertility. At present, using frozen embryo transplantation after ovulation induction by clomiphene citrate is a common treatment, but few research has mentioned the best time for embryo implantation. The investigators research is to find the most appropriate time for frozen embryo implantation after using clomiphene citrate for ovulation induction.

NCT ID: NCT02201914 Recruiting - IVF Clinical Trials

Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF

Start date: January 2014
Phase: Phase 4
Study type: Interventional

Poor ovarian response to stimulation in IVF cycles is a challenging and frustrating condition, due to its poor prognosis in terms of chances of pregnancy and live births. Various ovarian stimulation regimens have been tried to overcome these obstacles. A simple approach is increase the dose of the gonadotropin administration, but the results in terms of pregnancy rate are very low Another commonly used stimulation regimen is the microdose GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature LH surge, with fewer cycle cancellations. However, their application in poor responders, even if in small doses and for a limited period, has been questioned as they may cause oversuppression of ovarian function, leading to a prolonged cycle and increased treatment costs without improving the outcomes. Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing a premature LH surge and allow for a more natural recruitment of follicles in the follicular phase in a non-suppressed ovary, offering a potential alternative in the treatment of these patients. However, randomized studies evaluating the efficacy of this regimen in poor responders did not show any improvements in pregnancy rates. Current approach have included the addition of oral agents such us clomiphene citrate (CC) to gonadotropins. Some authors have investigated the role of CC in addition to low dose of gonadotropins in mild stimulation regimen, demonstrating that, despite a small number of retrieved oocytes, good quality embryos were produced with a subsequent improvement in the fertilization rate, clinical pregnancy rate and live birth rate. The only study that evaluate the efficacy of CC in addition to high doses of gonadotropins in poor responders showed improving in number of retrieved oocytes, transferred embryos and biochemical pregnancy; however, clinical pregnancy rate and live birth rate remained low and showed no measurable increase. The aim of this study was to compare the efficacy of the CC as an adjunctive to a high dose of gonadotropins in cycles with antagonist protocols with the microdose GnRH agonist and flexible antagonist protocols in women who responded poorly to ovarian stimulation, to determine whether this protocol may improve IVF outcomes, offering a valid alternative in poor responder patients treatment.