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1
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Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome.
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Legro RS; Barnhart HX; Schlaff WD; Carr BR; Diamond MP; Carson SA; Steinkampf MP; Coutifaris C; McGovern PG; Cataldo NA; Gosman GG; Nestler JE; Giudice LC; Leppert PC; Myers ER
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N Engl J Med. 2007 Feb 8;356(6):551-66.
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BACKGROUND: The polycystic ovary syndrome is a common cause of infertility. Clomiphene and insulin sensitizers are used alone and in combination to induce ovulation, but it is unknown whether one approach is superior. METHODS: We randomly assigned 626 infertile women with the polycystic ovary syndrome to receive clomiphene citrate plus placebo, extended-release metformin plus placebo, or a combination of metformin and clomiphene for up to 6 months. Medication was discontinued when pregnancy was confirmed, and subjects were followed until delivery. RESULTS: The live-birth rate was 22.5% (47 of 209 subjects) in the clomiphene group, 7.2% (15 of 208) in the metformin group, and 26.8% (56 of 209) in the combination-therapy group (P<0.001 for metformin vs. both clomiphene and combination therapy; P=0.31 for clomiphene vs. combination therapy). Among pregnancies, the rate of multiple pregnancy was 6.0% in the clomiphene group, 0% in the metformin group, and 3.1% in the combination-therapy group. The rates of first-trimester pregnancy loss did not differ significantly among the groups. However, the conception rate among subjects who ovulated was significantly lower in the metformin group (21.7%) than in either the clomiphene group (39.5%, P=0.002) or the combination-therapy group (46.0%, P<0.001). With the exception of pregnancy complications, adverse-event rates were similar in all groups, though gastrointestinal side effects were more frequent, and vasomotor and ovulatory symptoms less frequent, in the metformin group than in the clomiphene group. CONCLUSIONS: Clomiphene is superior to metformin in achieving live birth in infertile women with the polycystic ovary syndrome, although multiple birth is a complication. (ClinicalTrials.gov number, NCT00068861 [ClinicalTrials.gov].).
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Department of Obstetrics and Gynecology, Pennsylvania State University College of Medicine, M.S. Hershey Medical Center, Hershey, PA 17033, USA. rsl1@psu.edu
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| PMID |
17287476
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2
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Use of clomiphene citrate in women. Fertil Steril 2003; 80:1302.
no abstract available
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3
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Clomiphene citrate for unexplained subfertility in women.
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Hughes E; Collins J; Vandekerckhove P
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Cochrane Database Syst Rev 2000;(3):CD000057.
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BACKGROUND: The effectiveness of clomiphene citrate has been clearly demonstrated in the treatment of sub-fertility associated with oligo-ovulation. The multiple pregnancy rate associated with clomiphene, however, is elevated at approximately 10%. Additional side effects associated with clomiphene use also include hot flashes, mood swings, headaches and visual disturbances. A variety of publications have raised the question of increased ovarian cancer risks associated with clomiphene use. Understanding the effectiveness of clomiphene in this patient group is therefore, extremely important. OBJECTIVES: To determine the effectiveness of clomiphene citrate given to women with unexplained subfertility, in a dose range of 50-250 mg for up to 10 days. The primary outcome was clinical pregnancy. SEARCH STRATEGY: RCTs were identified using the search strategies developed for the menstrual disorders and subfertility group. See review group for more information. SELECTION CRITERIA: Randomized controlled trials were included if they were relevant to the clinical question posed and reported data in treated and untreated groups. Cohort studies were excluded. DATA COLLECTION AND ANALYSIS: Eleven potentially relevant trials were identified, of which six were included in this review. All trials were assessed for quality in terms of method of randomization, completeness of follow up, presence or absence of cross-over and co-intervention. MAIN RESULTS: Clomiphene appeared to be superior to no treatment or placebo. The common odds ratios for clinical pregnancy per patient and per treatment cycle were 2.37 (1.22-4.62) and 2.5 (1.35-4.62) respectively. Although there was some clinical heterogeneity between studies, the results were statistically homogeneous (p>0.1). These data suggest statistically and clinically significant improvement in pregnancy rate following clomiphene citrate in women with unexplained infertility. REVIEWER'S CONCLUSIONS: Although the absolute treatment effect is small, given the low cost and ease of administration, clomiphene citrate appears to be a sensible first choice treatment for women with unexplained infertility. However, in making this treatment choice, concerns of long-term use and ovarian cancer risk, multiple pregnancy risk and minor symptoms should be discussed. Given the extensive use of clomiphene in ovulatory women and recent concerns associated with long term use, a definitive trial with adequate power is warranted to establish effectiveness in women with unexplained subfertility.
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Rm HSC-4F7, Department of Obstetrics and Gynaecology, McMaster University, 1200 Main St West, Hamilton, Ontario, Canada, L8N 3Z5. hughese@fhs.csu.mcmaster.ca
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| PMID |
10908459
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4
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Comparison of low-technology and high-technology monitoring of clomiphene citrate ovulation induction.
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Smith YR; Randolph JF Jr; Christman GM; Ansbacher R; Howe DM; Hurd WW
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Fertil Steril 1998 Jul;70(1):165-8.
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OBJECTIVE: To determine whether newer monitoring techniques, including urinary detection of the LH surge and vaginal ultrasound, offer an advantage over basal body temperature (BBT) charts alone in achieving pregnancy using clomiphene citrate (CC). DESIGN: Randomized clinical trial. SETTING: Infertility patients in an academic research environment. PATIENT(S): Forty-five women undergoing ovulation induction with CC. INTERVENTION(S): The women were assigned randomly to receive either low- or high-technology ovulation monitoring for a total of 3 ovulatory cycles. Both groups were followed with BBT charts. The high-technology group also was monitored with urinary LH kits and vaginal ultrasound. MAIN OUTCOME MEASURE(S): Cycle fecundity rates for each technique were compared statistically with use of life-table analysis. RESULT(S): Forty-five patients were studied during a total of 134 cycles. The overall cycle fecundity rate was 8%, 10% (8 of 81 cycles) for the low-technology monitoring group and 6% (3 of 53 cycles) for the high-technology monitoring group. These rates were not statistically significant when evaluated by Fisher's exact test (P = .53) or when using life-table analysis and a log-rank test (P = .48). CONCLUSION(S): These data suggest that, for initial attempts at ovulation induction with CC in unselected patients, high-technology monitoring of ovulation offers no increase in fecundity over low-technology monitoring.
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Department of Obstetrics and Gynecology, University of Michigan Medical Center, Ann Arbor 48109-0276, USA. ysmith@umich.edu
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| PMID |
9660442
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