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Randomized controlled trial of Letrozole versus Clomiphene citrate for induction of ovulation in polycystic ovarian syndrome (PCOS): A Malaysian experience  [PDF]
Nik Hazlina Nik Hussain, Munawwirah Ismail, Murizah Mohd. Zain, Pu Chan Yeu, Roszaman Ramli, Wan Mohd Zahiruddin Wan Mohammad
Open Journal of Obstetrics and Gynecology (OJOG) , 2013, DOI: 10.4236/ojog.2013.35A2003

Background: The purpose of this study was to compare the effectiveness of Letrozole versus Clomiphene citrate for ovulation induction in polycystic ovarian syndrome (PCOS) with infertility. Methods: This was a prospective randomized trial involving 150 women with PCOS attending the Infertility Clinic at three hospitals in Malaysia. During the initial visit, anthropometric measurements and baseline investigations were performed. Patients were randomized to 5.0 mg Letrozole daily (75 patients) or 100 mg Clomiphene citrate daily (75 patients) from the fifth until the ninth day of menstruation. Serial transvaginal scans were performed to see the dominant follicles, endometrial thickness and number of follicles. Transvaginal scans were performed serially to look for evidence of ovulation. Results: The subjects were homogenously distributed. The difference between Letrozole and Clomiphene citrate for ovulation rate was 59 (78.7%) versus 40 (53.3%). Patients taking Letrozole exhibited a mean endometrial thickness (ET) at mid cycle of menses (Day 11-D14) of9.2 mm(SD ± 2.3) versus8.4 mm(SD ± 2.2) for patients taking Clomiphene citrate, and these differences were statistically significant (p < 0.001). In terms of pregnancy rate, Letrozole facilitated pregnancy induction in 19 patients (25.3%) versus 12 patients (16.0%) for Clomiphene citrate; however, this was not statistically significant (p = 0.22). More dominant follicles exhibiting a monofollicular morphology were observed in patients treated with Letrozole compared to patients treated with Clomiphene citrate, with a monofollicular dominant follicle observed in 33 (46.5%) versus 20 (26.7%) patients, respectively. Conclusion: Letrozole provided a more efficient stimulation compared to Clomiphene citrate in terms of ovulation induction, thickening of the endometrial lining and achievement of a successful pregnancy. Clinical Trials. gov Identifier: NCT015-77017.

Letrozole versus Clomiphene Citrate for Induction of Ovulation in Patients with Polycystic Ovarian Syndrome Undergoing Intrauterine Insemination
Sherif F. Hendawy, Hanan E. Samaha and Mohamed F. Elkholy
Clinical Medicine Insights: Reproductive Health , 2012, DOI: 10.4137/CMRH.S6598
Abstract: Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies affecting women in the reproductive age group, and is one of the most common causes of hyperandrogenic anovulatory infertility. The aromatase inhibitor, letrozole, has been used for induction of ovulation. The purpose of this study was to compare the effects of letrozole and clomiphene citrate in induction of ovulation among patients with PCOS undergoing intrauterine insemination. Methods: In a double-blind randomized study, 60 infertile patients with PCOS received standard doses of either clomiphene citrate or letrozole as an induction protocol prior to intrauterine insemination. A hormonal profile, pelvic ultrasound, hysterosalpingogram, and/or laparoscopy were done for all patients. The patients were monitored for ovulation by translational ultrasonographic folliculometry, with measurement of number and size of the follicles, as well as endometrial thickness. Human chorionic gonadotrophin (HCG) was injected intramuscularly when at least one mature follicle ≥ 18 mm diameter was detected, and intrauterine insemination was performed 32–36 hours later. Transvaginal ultrasound and β-HCG measurement were performed for confirmation of pregnancy. Results: Letrozole and clomiphene citrate achieved follicle maturation within a mean ± standard deviation (SD) of 13.2 ± 1.53 and 14.1 ± 1.35 days, respectively, showing no significant difference (P > 0.05). The mean number of follicles reaching ≥18 mm on the day of HCG administration was significantly higher in patients who received clomiphene citrate (2.9 ± 1.77) than in those receiving letrozole (1.2 ± 0.9). Letrozole had a significantly greater effect than clomiphene citrate on endometrial thickness (9.16 ± 1.36 versus 4.46 ± 1.71). The number of pregnancies achieved in the letrozole group was significantly (P > 0.05) greater than in the clomiphene group. Conclusion: Letrozole in patients with PCOS is as effective as clomiphene citrate in inducing ovulation, and although the number of follicles produced by induction with letrozole were less than those produced by clomiphene, letrozole had a significantly greater effect on endometrial thickness than clomiphene citrate, and the incidence of pregnancy after intrauterine insemination was significantly higher, with a lower incidence of multiple pregnancy.
Comparison of the Effects of Letrozole and Clomiphene Citrate on Ovulation and Pregnancy Rate in Patients with Polycystic Ovary Syndrome
Sedigheh Dehbashi,Sara Dehbashi,Talieh Kazerooni,Minoo Robati
Iranian Journal of Medical Sciences , 2009,
Abstract: Background: For more than four decades clomiphene citratehas been the first line of the treatment for ovulatory disorders.The aim of this study was to compare the effects of letrozoleand clomiphene citrate on ovulation and pregnancy rate in patientswith polycystic ovary syndrome.Methods: In this prospective double-blind study, 100 patientswith polycystic ovary syndrome were randomized into twoequal groups. The first group received letrozole, 5mg daily(per oral) and the second group received clomiphene, 100mgdaily during the 3rd-7th days of the menstrual cycles. Intramuscularhuman chorionic gonadotropin (hCG) (10,000 IU)was administered to trigger ovulation when at least one maturefollicle (≥ 18mm) was developed.Results: Ovulation occurred in 30 patients (60%) of the letrozolegroup and in 16 patients (32%) of the clomiphene group,which showed a statistically significant difference (P=0.009).The mean number of follicles with diameter >14 mm on theday of administration of hCG was 1.06±0.95 in the letrozolegroup and 1.14±1.17 in the clomiphene group, which showednon-significant difference (P=0.962).No difference was found in the endometrial thicknessbetween the two groups. A non-significant increase inpregnancy rate was observed in the letrozole group (26% v14% P=0.21).Conclusion: Ovulation rate was higher in letrozole group andadministration of letrozole was associated with a nonsignificantincrease in pregnancy rate.
Comparing Two Ovulation Induction Methods by Brachial Artery Ultrasonography in Infertile Women with Polycystic Ovary Syndrome
L Safdarian,N Satari Dibazar,A Ahmadzadeh,B Ghorbani Yekta
Tehran University Medical Journal , 2012,
Abstract: Background: Endothelial dysfunction can influence fertility rate in women with polycystic ovary syndrome (PCOS) as flow mediated dilatation (FMD) is impaired in patients with the disease. The aim of this study was to compare two methods of ovulation induction by letrozole or letrozole plus human menopausal gonadotropins (HMGs) in infertile women with PCOS who were resistant to clomiphene citrate based on brachial artery ultrasound findings.Methods: In this double -blind randomized clinical trial, 59 infertile women who had the inclusion criteria for PCOS were evaluated in the Infertility Clinic of Shariati Hospital in Tehran, Iran in 2010-2011. The patients were assigned to two letrozole and letrozole plus HMG groups and were evaluated for FMD in the brachial artery by transvaginal ultrasonography. Later, the values were recorded and analyzed statistically.Results: In the letrozole group, infertility treatment was successful in 15 (57.7%) but it failed in 11 (42.3%) patients. In letrozole plus HMG group, the treatment was successful in 18 (54.5%) while it failed in 15 (45.5%) patients. The mean FMD values in the groups with successful and unsuccessful treatment results were 19.42±10% and 18.57±7.2%, respectively, but the difference was not statistically significant (P=0.712). Moreover, the average endometrial thickness in groups with successful and unsuccessful treatment results were 8.4±1.3 mm and 9.8±3.9 mm, respectively but the difference was not significant either (P=0.06).Conclusion: In infertile women with polycystic ovary syndrome that are resistant to clomiphene, letrozole or letrozole combined with gonadotropin can be equally effective for ovulation induction.
Comparison of pregnant and non-pregnant women with clomiphene resistant polycystic ovary syndrome in treatment with metformin and letrozole
Azam Azargoon,Jafar Alavi Toussy
Koomesh , 2011,
Abstract: Introduction: Polycystic ovary syndrome (PCOS) is one of the most common causes of anovulatory infertility. Clomiphen citrate (CC) is the first line therapy for women with infertility and PCOS. These patients usually respond to clomiphene citrate in doses between 50-100 mg/day. However, fialure of the patient to respond to a dosage of 150 mg/day of clomiphene citrate is considered as clomiphene resistant. The aim of this study was to compare between pregnant and non-pregnant women in cases of PCOS patients with CC resistant. Meanwhile, we evaluated ovulatory rate, pregnancy rate and live birth rates. Materials and Methods: We studied 106 CC-resistant PCOS patients who attended to Amir-Al- Momenin Hospital (Semnan, Iran) during the years 2005-2008. After an initial 6-8 weeks of metformin (1500mg daily: 500mg q8h), they received 2.5mg letrozole for 5 days starting on cycle day 3. If they failed to show ovluation with 2.5mg letrozole, doses were increased to 5 and 7.5 mg daily in the subsequent cycles. Results: One patient developed generalized rash with metformin and excluded from the study. 14 of 105 patients (13.33%) conceived with metformin alone. Overall, ovulation rate was 83.91(91.2%). Overall, pregnancy rate was 60/105 (57.14%) with 45 (74.9%) full term pregnancies, 10 (16.7%) abortions and 5 (8.3%) preterm births. The only significant difference between the responder and non-responder was found in the age of patients (P=0.008) . No significant differences were found in BMI, period of infertility, menstrual pattern, hirsutism, pictures of PCO in one or two ovaries in sonography, LH, and FSH or LH/FSH ratio. Conclusion: Combination of metformin with incremental doses of letrozole associated with a good pregnancy rate in CC-resistant PCOS patients. The treatment seems especially more effective in young weman.
Clinical Observation of 242 Cases of Polycystic Ovary Syndrome  [PDF]
Yushuang Shi, Cunjian Yi
Yangtze Medicine (YM) , 2018, DOI: 10.4236/ym.2018.24023
Abstract: Objective: To compare the clinical effect and safety between letrozole (LE) and clomiphene citrate (CC) stimulated cycles in women with polycystic ovary syndrome (PCOS). To evaluate the effectivenesses and benefits of letrozole for ovulation induction in infertile women with PCOS. Methods: We retrospectively analyze the clinical data of 242 cases of the first ovulation induction cycle patients with PCOS, who referred to the Department of Reproductive Medicine, The First Affiliated Hospital of Yangtze University from June 2016 to June 2018, and were randomly divided into letrozole group and control group. The experimental group received Letrozole 2.5 mg/d for 5 days during days 3 - 7 of menstrual cycle. The control group was given clomiphene citrate 100 mg/d for 5 days during days 3 - 7 of menstrual cycle. Progynova will be used when the follicular diameter is 14 mm. Results: Letrozole group had less mature follicles, lower estrogen levels, thicker endometrium and higher ovulation rate in HCG day. But there is no difference between two groups in clinical pregnancy rate, single pregnancy rate, abortion rate, prenatal pregnancy delivery and newborns. Conclusion: Letrozole and clomiphene citrate have similar effect on ovulation induction, but we still need a lot of clinical data of letrozole about the safety of follicle, embryo, fetus and newborns.
Incorporating patient preference into the management of infertility in women with polycystic ovary syndrome
Okoroafor UC,Jungheim ES
Patient Preference and Adherence , 2012,
Abstract: Ugochi C Okoroafor, Emily S JungheimDepartment of Obstetrics and Gynecology, Washington University, St Louis, MO, USAAbstract: Polycystic ovary syndrome (PCOS) is a heterogeneous condition characterized by anovulation, hyperandrogenism, and polycystic ovaries. Because of the heterogeneous nature of PCOS, women affected by the condition often require a customized approach for ovulation induction when trying to conceive. Treating symptoms of PCOS in overweight and obese women should always incorporate lifestyle changes with the goal of weight-loss, as many women with PCOS will ovulate after losing 5%–10% of their body weight. On the other hand, other factors must be considered including the woman’s age, age-related decline in fertility, and previous treatments she may have already tried. Fortunately, multiple options for ovulation induction exist for women with PCOS. This paper reviews specific ovulation induction options available for women with PCOS, the benefits and efficacy of these options, and the related side effects and risks women can anticipate with the various options that may affect treatment adherence. The paper also reviews the recommended evidence-based strategies for treating PCOS-related infertility that allow for incorporation of the patient’s preference. Finally, it briefly reviews emerging data and ongoing studies regarding newer agents that have shown great promise as first-line agents for the treatment of infertility in women with PCOS.Keywords: polycystic ovary syndrome, anovulation, clomiphene citrate, letrozole, metformin, obesity
Thiazolidinediones and Fertility in Polycystic Ovary Syndrome (PCOS)  [PDF]
Pascal Froment,Philippe Touraine
PPAR Research , 2006, DOI: 10.1155/ppar/2006/73986
Abstract: Polycystic ovary syndrome (PCOS) is the most frequent cause of female infertility. The treatment of PCOS patients with insulin sensitizers, such as metformin or thiazolidinediones, increases the ovulation rate and the number of successful pregnancies. The positive action of the insulin-sensitizing treatments could be explained by a decrease in the peripheral insulin resistance but also by a direct action at the ovarian level. We report in this review different hypotheses of thiazolidinediones actions to improve PCOS (steroid secretion by ovarian cells ; insulin sensitivity in muscle and adipocyte and fat redistribution).
Current trends in the treatment of polycystic ovary syndrome with desire for children
Margalida E Sastre,Maria O Prat,Miguel Angel Checa,Ramon C Carreras
Therapeutics and Clinical Risk Management , 2009,
Abstract: Margalida E Sastre1, Maria O Prat1, Miguel Angel Checa1,2, Ramon C Carreras11Department of Obstetrics and Gynaecology; 2Unit of Endocrinological Gynaecology and Human Reproduction, Hospital del Mar, Autonomous University of Barcelona, Barcelona, SpainAbstract: Polycystic ovary syndrome (PCOS), one of the most frequent endocrine diseases, affects approximately 5%–10% of women of childbearing age and constitutes the most common cause of female sterility regardless of the need or not for treatment, a change in lifestyle is essential for the treatment to work and ovulation to be restored. Obesity is the principal reason for modifying lifestyle since its reduction improves ovulation and the capacity for pregnancy and lowers the risk of miscarriage and later complications that may occur during pregnancy (gestational diabetes, pre-eclampsia, etc). When lifestyle modification is not sufficient, the first step in ovulation induction is clomiphene citrate. The second-step recommendation is either exogenous gonadotrophins or laparoscopic ovarian surgery. Recommended third-line treatment is in vitro fertilization. Metformin use in PCOS should be restricted to women with glucose intolerance.Keywords: polycystic ovarian syndrome, clomiphene citrate, letrozole, lifestyle, pregnancy, obesity
Metformin-letrozole in comparison with Metformin-clomiphene citrate in clomiphene-resistance PCOS patients undergoing IUI
Robab Davar,Mojgan Javedani,Mohammad Hossein Fallahzadeh
Iranian Journal of Reproductive Medicine , 2011,
Abstract: Background: Polycystic ovary syndrome (PCOS) is associated with approximately 75% of women who suffer from infertility due to anovulation. Additionally, around 20– 25% of anovulatory women with PCOS do not respond at all to clomiphene citrate and are considered to be “clomiphene– resistant”. Aromatase inhibitors have been suggested as an alternative treatment to clomiphene as the discrepancy between ovulation and pregnancy rates with clomiphene citrate has been attributed to its anti-estrogenic action and estrogen receptor depletion. Objective: The aim of this study is to compare results of Metformin-letrozole with Metformin-clomiphene citrate in clomiphene resistance PCOS patients undergoing IUI.Materials and Methods: In this single blind randomized trial, ovarian cycles were studied in 100 clomiphene- resistant patients with PCOS. The inclusion criteria were patients who received 150mg clomiphene citrate daily for 3 cycles and failed to become pregnant. The patients were matched for their age, body mass index (BMI), and infertility period. They were randomly allocated to a metformin-letrozole group (n=50) and a metformin-clomiphene citrate group (n=50). Chemical and clinical pregnancies were assessed after IUI. Abortion rates were determined in both groups. Results: Regarding pregnancy rate, there was no significant difference between the two groups. One miscarriage (2%) occurred in the metformin-clomiphene citrate group, whereas none was seen in the metformin-letrozole group. Conclusion: There is no significant difference in pregnancy rate between clomiphene citrate and letrozole groups although it has been 2% in the former and 5% in the latter.
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