title: [Using an ovarian drilling by hydrolaparoscopy or recombinant follicle stimulating hormone plus metformin to treat polycystic ovary syndrome: Why a randomized controlled trial fail?].
abstract: OBJECTIVE
  To evaluate pregnancy rates after randomized controlled trial (RCT) between ovarian drilling by fertiloscopy or ovarian hyperstimulation+insemination+metformine after clomifène citrate (cc) treatment fails.
  
  
  METHODS
  Randomized controlled trial with 126 patients in each arm in 9 university centers. After 6-9 months of stimulation by cc, 2 groups were randomized: group 1, ovarian drilling with bipolar energy versus group 2: 3 months treatment by metformine followed by 3 hyperstimulation by FSH+insemination. The success rate was pregnancy rate above 12 weeks.
  
  
  RESULTS
  RCT was stopped after the screening of 40 patients. In spite of the low number of patients, the pregnancy rate is significantly higher in medical group 8/16 versus 3/18 (p=0.04).
  
  
  CONCLUSIONS
  The causes of fail of RCT were in relationship with difficulties of inclusion, with absence of final agreement by team included. Moreover, RCT between medical and surgical management is often root of difficulties for patients who decline surgical strategy. However, medical treatment appeared better than drilling in this RCT.
authors.affiliation: Service de gynécologie obstétrique, hôpital Bicêtre, AP-HP, 78, rue du Général-Leclerc, 94270 Le Kremlin-Bicêtre, France; CESP-Inserm U1018, 82, rue du Général-Leclerc, 94276 Le Kremlin-Bicêtre, France; Université Paris-Sud, 63, rue Gabriel-Péri, 94270 Le Kremlin-Bicêtre, France. Electronic address: herve.fernandez@bct.aphp.fr.
authors.forename: H
authors.initials: H
authors.lastname: Fernandez
authors.affiliation: Service de médecine de la reproduction, hôpital Jean-Verdier, AP-HP, avenue du 14-Juillet, 93140 Bondy, France.
authors.forename: I
authors.initials: I
authors.lastname: Cedrin-Durnerin
authors.affiliation: Service de gynécologie obstétrique, hôpital Antoine-Béclère, AP-HP, 157, rue de la Porte-de-Trivaux, 92140 Clamart, France.
authors.forename: V
authors.initials: V
authors.lastname: Gallot
authors.affiliation: Service de gynécologie obstétrique, CMCO hôpitaux universitaires de Strasbourg, 19, rue Louis-Pasteur, 67300 Schiltigheim, France.
authors.forename: C
authors.initials: C
authors.lastname: Rongieres
authors.affiliation: Service de gynécologie obstétrique, centre de chirurgie gynécologique, 22, avenue Rockfeller, 69008 Lyon, France.
authors.forename: A
authors.initials: A
authors.lastname: Watrelot
authors.affiliation: Service de gynécologie obstétrique, hôpital de Sèvres, 141, Grande-Rue, 92310 Sèvres, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Mayenga-Mankezi
authors.affiliation: Unité recherche clinique (URC) Paris-Sud, 78, rue du Général-Leclerc, 94270 Le Kremlin-Bicêtre, France.
authors.forename: A
authors.initials: A
authors.lastname: Arnoux
mesh_terms: D000328:Adult; D002996:Clomiphene / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000494:pharmacology*; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D007247:Infertility, Female / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D010535:Laparoscopy / Q000379:methods*; D008687:Metformin / Q000008:administration & dosage / Q000494:pharmacology*; D010053:Ovary / Q000601:surgery*; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D011677:Punctures / Q000379:methods*; D011994:Recombinant Proteins; D017211:Treatment Failure
chemical_list: D005300:Fertility Agents, Female; D007004:Hypoglycemic Agents; D011994:Recombinant Proteins; D002996:Clomiphene; D005640:Follicle Stimulating Hormone; D008687:Metformin
keywords: Drilling ovarien; Fertiloscopie; Fertiloscopy; Induction de l’ovulation; Ovarian drilling; Ovarian hyperstimulation