Metformin administration versus laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: A prospective parallel randomized double-blind placebo-controlled trial

Journal of Clinical Endocrinology and Metabolism

Volumn 89, Issue 10, 2004, Pages 4801-4809

  Palomba, Stefano ^a   Orio Jr , Francesco ^b   Nardo, Luciano Giovanni ^c   Falbo, Angela ^a   Russo, Tiziana ^a   Corea, Domenico ^a   Doldo, Patrizia ^a   Lombardi, Gaetano ^b   Tolino, Achille ^b   Colao, Annamaria ^b   Zullo, Fulvio ^a  

^a UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^c ST MARY S HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; CLOMIFENE CITRATE; MEDROXYPROGESTERONE ACETATE; METFORAL; METFORMIN; MULTIVITAMIN; PLACEBO; UNCLASSIFIED DRUG;

ABORTION; ADULT; ANOVULATION; ARTICLE; BIRTH RATE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIATHERMY; DOUBLE BLIND PROCEDURE; DRUG COST; DRUG TOLERABILITY; FEMALE; FEMALE INFERTILITY; FLATULENCE; GYNECOLOGIC SURGERY; HEALTH CARE COST; HOSPITAL DISCHARGE; HUMAN; LAPAROSCOPIC OVARIAN DIATHERMY; LAPAROSCOPIC SURGERY; LAPAROSCOPY; MAJOR CLINICAL STUDY; NAUSEA; OBESITY; OVARY POLYCYSTIC DISEASE; OVULATION INDUCTION; PEROPERATIVE COMPLICATION; POSTOPERATIVE COMPLICATION; POSTOPERATIVE HEMORRHAGE; PREGNANCY RATE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMACH PAIN; TREATMENT OUTCOME;

ADULT; AMBULATORY SURGICAL PROCEDURES; CLOMIPHENE; DOUBLE-BLIND METHOD; DRUG RESISTANCE; ELECTROCOAGULATION; FEMALE; FERTILITY AGENTS, FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; LAPAROSCOPY; METFORMIN; PATIENT DROPOUTS; PLACEBOS; POLYCYSTIC OVARY SYNDROME; PREGNANCY; PREGNANCY OUTCOME; PROSPECTIVE STUDIES;

FALLOPIA;

EID: 6344245947     PISSN: 0021972X     EISSN: None     Source Type: Journal    
DOI: 10.1210/jc.2004-0689     Document Type: Article

References (82)

1. Frank S 1995 Polycystic ovary syndrome. N Engl J Med 333:853-861
2. Knochenhauer ES, Key TJ, Kahsar-Miller M, Waggoner W, Boots LR, Azziz R 1998 Prevalence of the polycystic ovary syndrome in unselected black and white women of the southeastern United States: a prospective study. J Clin Endocrinol Metab 83:3078-3082
3. Adams J, Polson DW, Franks S 1986 Prevalence of polycystic ovaries in women with anovulation and idiopathic hirsutism. Br Med J 293:355-359
4. Hull MG 1987 Epidemiology of infertility and polycystic ovarian disease: endocrinological and demographic studies. Gynaecol Endocrinol 1:235-245
5. Zawadzki JK, Dunaif A 1992 Diagnostic criteria for polycystic ovary syndrome: towards a rational approach. In: Dunaif A, Givens JR, Haseltine FP, Merriam GR, eds. Polycystic ovary syndrome. Boston: Blackwell; 337-384
6. Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group 2004 Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril 81:19-25
7. Palomba S, Orio Jr F, Russo T, Falbo A, Cascella T, Colao A, Lombardi G, Zullo F, Is ovulation induction still a therapeutic problem in patients with polycystic ovary syndrome? J Endocrinol Invest, in press
8. Hughes E, Collins J, Vandekerckhove P 2000 Clomiphene citrate for unexplained subfertility in women. Cochrane Database Syst Rev, vol 3
9. Pirwany I, Tulandi T 2003 Laparoscopic treatment of polycystic ovaries: is it time to relinquish the procedure? Fertil Steril 80:241-251
10. Farquhar C, Vandekerckhove P, Lilford R 2001 Laparoscopic "drilling" by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev 4:CD001122
11. Gurgan T, Urman B 1994 Adhesions after ovarian drilling and intercede. Fertil Steril 62:424-426
12. Felemban A, Tan SL, Tulandi T 2000 Laparoscopic treatment of polycystic ovaries with insulated needle cautery: a reappraisal. Fertil Steril 73:266-269
13. Operative Laparoscopy Study Group 1991 Postoperative adhesion development after operative laparoscopy: evaluation at early second-look procedures. Fertil Steril 55:700-704
14. Gurgan T, Kisnisci H, Yarali H, Develioglu O, Zeyneloglu H, Aksu T 1991 Evaluation of adhesion formation after laparoscopic treatment of polycystic ovarian disease. Fertil Steril 56:1176-1178
15. Saravelos H, Li TC 1996 Post-operative adhesions after laparoscopic electrosurgical treatment for polycystic ovarian syndrome with the application of Interceed to one ovary: a prospective randomized controlled study. Hum Reprod 11:992-997
16. Nestler JE, Jakubowicz DJ, Evans WS, Pasquali R 1998 Effects of metformin on spontaneous and clomiphene-induced ovulation in the polycystic ovary syndrome. N Engl J Med 338:1876-1880
17. Homburg R 2002 Should patients with polycystic ovarian syndrome be treated with metformin? A note of cautious optimism. Hum Reprod 17:853-856
18. Lord JM, Flight IH, Norman RJ 2003 Insulin-sensitising drugs (metformin, troglitazone, rosiglitazone, pioglitazone, D-chiro-inositol) for polycystic ovary syndrome. Cochrane Database Syst Rev 3:CD003053
19. Malkawi HY, Qublan HS, Hamaideh AH 2003 Medical vs. surgical treatment for clomiphene citrate-resistant women with polycystic ovary syndrome. J Obstet Gynaecol 23:289-293
20. Heiat A 2003 Impact of age on definition of standards for ideal weight. Prev Cardiol 6:104-107
21. Modan M, Harris MI, Halkin H 1989 Evaluation of WHO and NDDG criteria for impaired glucose tolerance. Results from two national samples. Diabetes 38:1630-1635
22. Ferriman D, Gallwey JD 1961 Clinical assessment of body hair growth in women. J Clin Endocrinol Metab 21:1440-1447
23. Palomba S, Orio Jr F, Colao A, Di Carlo C, Sena T, Lombardi G, Zullo F, Mastrantonio P 2002 Effect of estrogen replacement plus low-dose alendronate treatment on bone density in surgically postmenopausal women with osteoporosis. J Clin Endocrinol Metab 87:1502-1508
24. Glueck CJ, Wang P, Fontaine R, Tracy T, Sieve-Smith L 1999 Metformin-induced resumption of normal menses in 39 of 43 (91%) previously amenorrheic women with the polycystic ovary syndrome. Metabolism 48:511-519
25. Glueck CJ, Phillips H, Cameron D, Sieve-Smith L, Wang P 2001 Continuing metformin throughout pregnancy in women with polycystic ovary syndrome appears to safely reduce first-trimester spontaneous abortion: a pilot study. Fertil Steril 75:46-52
26. Glueck CJ, Goldenberg N, Wang P, Loftspring M, Sherman A 2004 Metformin during pregnancy reduces insulin, insulin resistance, insulin secretion, weight, testosterone and development of gestational diabetes: prospective longitudinal assessment of women with polycystic ovary syndrome from preconception throughout pregnancy. Hum Reprod 19:510-521
27. Tulandi T 1999 Laparoscopic treatment of polycystic ovarian syndrome. In: Tulandi T, ed. Atlas of laparoscopic and hysteroscopic techniques for gynecologists. London: WB Saunders; 93-95
28. Pellicano M, Bramante S, Cirillo D, Palomba S, Bifulco G, Zullo F, Nappi C 2003 Effectiveness of autocrosslinked hyaluronic acid gel after laparoscopic myomectomy in infertile patients: a prospective, randomized, controlled study. Fertil Steril 80:441-444
29. Orio Jr F, Palomba S, Di Biase S, Colao A, Tauchmanovà L, Savastano S, Labella D, Russo T, Zullo F, Lombardi G 2003 Homocysteine levels and C677T polymorphism of methylenetetrahydrofolate reductase in women with polycystic ovary syndrome. J Clin Endocrinol Metab 88:673-679
30. Morley JE, Patrick P, Perry III HM 2002 Evaluation of assays available to measure free testosterone. Metabolism 51:554-559
31. Tai MM 1994 A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care 17:152-154
32. 1985 Revised American Fertility Society classification of endometriosis. Fertil Steril 43:351-352
33. Gleicher N 2000 Cost-effective infertility care. Hum Reprod Update 6:190-199
34. Wang CF, Gemzell C 1980 The use of human gonadotropins for the induction of ovulation in women with polycystic ovarian disease. Fertil Steril 33:479-486
35. Garcea N, Campo S, Panetta V, Venneri M, Siccardi P, Dargenio R, De Tomasi F 1985 Induction of ovulation with purified urinary follicle-stimulating hormone in patients with polycystic ovarian syndrome. Am J Obstet Gynecol 151:635-640
36. Neyro JL, Barrenetxea G, Montoya F, Rodriguez-Escudero 1991 Pure FSH for ovulation induction in patients with polycystic ovary syndrome and resistant to clomiphene citrate therapy. Hum Reprod 6:218-221
37. Abdel Gadir A, Mowafi RS, Alnaser HM, Alrashid AH, Alonezi OM, Shaw RW 1990 Ovarian electrocautery versus human menopausal gonadotrophins and pure follicle stimulating hormone therapy in the treatment of patients with polycystic ovarian disease. Clin Endocrinol (Oxf) 33:585-592
38. Naether OG, Baukloh V, Fisher R, Kowalczyk T 1994 Long-term follow-up in 206 infertility patients with polycystic ovarian syndrome after laparoscopic electrocautery of the ovarian surface. Hum Reprod 9:2342-2349
39. Amer SA, Banu Z, Li TC, Cooke ID 2002 Long-term follow-up of patients with polycystic ovary syndrome after laparoscopic ovarian drilling: endocrine and ultrasonographic outcomes. Hum Reprod 17:2851-2857
40. Kriplani A, Manchanda R, Agarwal N, Nayar B 2001 Laparoscopic ovarian drilling in clomiphene citrate-resistant women with polycystic ovary syndrome. J Am Assoc Gynecol Laparosc 8:511-518
41. Gjonnaess H 1998 Late endocrine effects of ovarian electrocautery in women with polycystic ovary syndrome. Fertil Steril 69:697-701
42. Lemieux S, Lewis GF, Ben-Chetrit A, Steiner G, Greenblatt EM 1999 Correction of hyperandrogenemia by laparoscopic ovarian cautery in women with polycystic ovarian syndrome is not accompanied by improved insulin sensitivity or lipid-lipoprotein levels. J Clin Endocrinol Metab 84:4278-4282
43. Tulandi T, Saleh A, Morris D, Jacobs HS, Payne NN, Tan SL 2000 Effects of laparoscopic ovarian drilling on serum vascular endothelial growth factor and on insulin responses to the oral glucose tolerance test in women with polycystic ovary syndrome. Fertil Steril 74:585-588
44. Saleh A, Morris D, Tan SL, Tulandi T 2001 Effects of laparoscopic ovarian drilling on adrenal steroids in polycystic ovary syndrome patients with and without hyperinsulinemia. Fertil Steril 75:501-504
45. Velazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ 1994 Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism 43:647-654
46. Velazquez EM, Acosta A, Mendoza S 1997 Menstrual cyclicity after metformin therapy in polycystic ovary syndrome. Obstet Gynecol 90:392-395
47. Kolodziejczk B, Duleba AJ, Spaczynski RZ, Pawelczyk L 2000 Metformin therapy decreases hyperandrogenism and hyperinsulinemia in women with polycystic ovary syndrome. Fertil Steril 73:1149-1154
48. Morin-Papunen LC, Koivunen RM, Ruokonen A, Martikainen HK 1998 Metformin therapy improves the menstrual pattern with minimal endocrine and metabolic effects with polycystic ovary syndrome. Fertil Steril 69:691-696
49. Diamanti-Kandarakis E, Kouli C, Tsianateli T, Bergiele A 1998 Therapeutic effects of metformin on insulin resistance and hyperandrogenism in polycystic ovary syndrome. Eur J Endocrinol 138:269-274
50. Unluhizarci K, Kelestimur F, Bayram F, Sahin Y, Tutus A 1999 The effects of metformin on insulin resistance and ovarian steroidogenesis in women with polycystic ovary syndrome. Clin Endocrinol (Oxf) 51:231-236
51. Pirwany IR, Yates RWS, Cameron IT, Fleming R 1999 Effects of the insulin sensitizing drug metformin on ovarian function, follicular growth and ovulation rate in obese women with oligomenorrhea. Hum Reprod 14:2963-2968
52. Moghetti P, Castello R, Negri C, Tosi F, Perrone F, Caputo M, Zanolin E, Muggeo M 2000 Metformin effects on clinical features, endocrine and metabolic profiles, and insulin sensitivity in polycystic ovary syndrome: a randomized, double-blind, placebo-controlled 6-month trial, followed by open, long-term clinical evaluation. J Clin Endocrinol Metab 85:139-146
53. Fleming R, Hopkinson ZE, Wallace AM, Greer IA, Sattar N 2002 Ovarian function and metabolic factors in women with oligomenorrhea treated with metformin in a randomized double blind placebo-controlled trial. J Clin Endocrinol Metab 87:569-574
54. Vandermolen DT, Ratts VS, Evans WS, Stovall DW, Kauma SW, Nestler JE 2001 Metformin increases the ovulatory rate and pregnancy rate from clomiphene citrate in patients with polycystic ovary syndrome who are resistant to clomiphene citrate alone. Fertil Steril 75:310-315
55. George SS, George K, Irwin C, Job V, Selvakumar R, Jeyaseelan V, Seshadri MS 2003 Sequential treatment of metformin and clomiphene citrate in clomiphene-resistant women with polycystic ovary syndrome: a randomized, controlled trial. Hum Reprod 18:299-304
56. De Leo V, la Marca A, Ditto A, Morgante G, Cianci A 1999 Effects of metformin on gonadotropin-induced ovulation in women with polycystic ovary syndrome. Fertil Steril 72:282-285
57. Stadtmauer LA, Toma SK, Riehl RM, Talbert LM 2001 Metformin treatment of patients with polycystic ovary syndrome undergoing in vitro fertilization improves outcomes and is associated with modulation of the insulin-like growth factors. Fertil Steril 75:505-509
58. Yarali H, Yildiz B, Demirol A, Zeyneloglu HB, Yigit N, Bukulmez O, Koray Z 2002 Co-administration of metformin during rFSH treatment in patients with clomiphene citrate-resistant polycystic ovarian syndrome: a prospective randomized trial. Hum Reprod 17:289-294
59. Stadtmauer LA, Toma SK, Riehl RM, Talbert LM 2002 Impact of metformin therapy on ovarian stimulation and outcome in 'coasted' patients with polycystic ovary syndrome undergoing in-vitro fertilization. Reprod Biomed Online 5:112-116
60. Nestler JE, Jakubowicz DJ 1997 Lean women with polycystic ovary syndrome respond to insulin reduction with decreases in ovarian P450c17α activity and serum androgens. J Clin Endocrinol Metab 82:4075-4079
61. Ng EH, Wat NM, Ho PC 2001 Effects of metformin on ovulation rate, hormonal and metabolic profiles in women with clomiphene-resistant polycystic ovaries: a randomized, double-blinded placebo-controlled trial. Hum Reprod 16:1625-1631
62. Dunaif A, Segal KR, Futterweit W, Dobrjansky A 1989 Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome. Diabetes 38:1165-1174
63. Morin-Papunen L, Vauhkonen I, Koivunen R, Ruokonen A, Martikainen H, Tapanainen JS 2003 Metformin versus ethinyl estradiol-cyproterone acetate in the treatment of nonobese women with polycystic ovary syndrome: a randomized study. J Clin Endocrinol Metab 88:148-156
64. Ehrmann DA, Cavaghan MK, Imperial J, Sturis J, Rosenfield RL, Polonsky KS 1997 Effects of metformin on insulin secretion, insulin action, and ovarian steroidogenesis in women with polycystic ovary syndrome. J Clin Endocrinol Metab 82:524-530
65. Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ 1995 Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod 10:2705-2712
66. Clark AM, Thornley B, Tomlinson L, Galletley C, Norman RJ 1998 Weight loss in obese infertile women results in improvement in reproductive outcome for all forms of fertility treatment. Hum Reprod 13:1502-1505
67. Crosignani PG, Colombo M, Vegetti W, Somigliana E, Gessati A, Ragni G 2003 Overweight and obese anovulatory patients with polycystic ovaries: parallel improvements in anthropometric indices, ovarian physiology and fertility rate induced by diet. Hum Reprod 18:1928-3192
68. Balen AH, Tan SL, MacDougall J, Jacobs HS 1993 Miscarriage rates following in-vitro fertilization are increased in women with polycystic ovaries and reduced by pituitary desensitization with buserelin. Hum Reprod 8:959-964
69. Homburg R, Armar NA, Eshel A, Adams J, Jacobs HS 1998 Influence of serum luteinising hormone concentrations on ovulation, conception, and early pregnancy loss in polycystic ovary syndrome. BMJ 297:1024-1026
70. Regan L, Owen EJ, Jacob HS 1990 Hypersecretion of luteinising hormone, infertility, and miscarriage. Lancet 336:1141-1144
71. Sagle M, Bishop K, Ridley N, Alexander FM, Michel M, Bonney RC, Beard RW, Franks S 1988 Recurrent early miscarriage and polycystic ovaries. BMJ 297:1027-1028
72. Watson H, Kiddy DS, Hamilton-Fairley D, Scanlon MJ, Barnard C, Collins WP, Bonney RC, Franks S 1993 Hypersecretion of luteinizing hormone and ovarian steroids in women with recurrent early miscarriage. Hum Reprod 8:829-833
73. Gray RH, Wu LY 2000 Subfertility and risk of spontaneous abortion. Am J Public Health 90:1452-1454
74. Regan L, Braude PR, Trembath PL 1989 Influence of past reproductive performance on risk of spontaneous abortion. BMJ 299:541-545
75. Clifford K, Rai R, Watson H, Regan L 1994 An informative protocol for the investigation of recurrent miscarriage: preliminary experience of 500 consecutive cases. Hum Reprod 9:1328-1332
76. Liddell HS, Sowden K, Farquhar CM 1997 Recurrent miscarriage: screening for polycystic ovaries and subsequent pregnancy outcome. Aust NZ J Obstet Gynaecol 37:402-406
77. Jakubowicz DJ, Iuorno MJ, Jakubowicz S, Roberts KA, Nestler JE 2002 Effects of metformin on early pregnancy loss in the polycystic ovary syndrome. J Clin Endocrinol Metab 87:524-529
78. Jakubowicz DJ, Iuorno MJ, Jakubowicz S, Roberts KA, Nestler JE, Metformin reduces early pregnancy loss in polycystic ovary syndrome. Program of the 83rd Annual Meeting of The Endocrine Society, Denver, CO, 2001, p 384 (Abstract P2-147).
79. Kocak M, Caliskan E, Simsir C, Haberal A 2002 Metformin therapy improves ovulatory rates, cervical scores, and pregnancy rates in clomiphene citrate-resistant women with polycystic ovary syndrome. Fertil Steril 77:101-106
80. Mansfield R, Galea R, Brincat M, Hole D, Mason H 2003 Metformin has direct effects on human ovarian steroidogenesis. Fertil Steril 79:956-962
81. Nestler JE, Stovall D, Akhter N, Iuorno MJ, Jakubowicz DJ 2002 Strategies for the use of insulin-sensitizing drugs to treat infertility in women with polycystic ovary syndrome. Fertil Steril 77:209-215
82. Kovacs GT, Clarke S, Burger HG, Healy DL, Vollenhoven B 2002 Surgical or medical treatment of polycystic ovary syndrome: a cost-benefit analysis. Gynecol Endocrinol 16:53-55