Alain Audebert

Dienogest is as effective as triptorelin in the treatment of endometriosis after laparoscopic surgery: results of a prospective, multicenter, randomized study

OBJECTIVE To compare the efficacy of Dienogest versus Decapeptyl at 3.75 mg as consolidation therapy for surgery in the treatment of endometriosis. DESIGN Multicenter, open, randomized, parallel-group clinical trial. SETTING Volunteer patients in an academic research environment. PATIENT(S) Women with grade 2, 3, and 4 (</=70) endometriosis at initial laparoscopy. INTERVENTION(S) We provided 16 weeks of treatment with Dienogest, 1 mg tablet daily; or with Decapeptyl, 3.75 mg IM injection every 4 weeks. MAIN OUTCOME MEASURE(S) A change in the patients Revised American Fertility Society score at the post-treatment laparoscopy. RESULT(S) From June 1994 to July 1998, 142 patients were enrolled in the trial. After exclusion for major protocol deviations, 59 patients were included in the Dienogest group and 61 in the Decapeptyl group. This study group was comparable to the first inclusion group. The patient demographic and clinical characteristics, median duration of endometriosis, Revised American Fertility Society scores, and Visual Analogic Squale (VAS) scores were comparable in both groups. Statistical analysis of efficacy was not significantly different between the two groups. Adverse events were reported by 87.7% of patients in the Dienogest group and 85.1% in the Decapeptyl group. Neither treatment affected patient body weight or vital signs. CONCLUSION(S) Dienogest is as effective as Decapeptyl for consolidation therapy after surgery for the treatment of endometriosis. The safety profile of dienogest differed from Decapeptyl (3.75 mg). Dienogest constitutes a new therapeutic alternative to the GnRH analogues.

Role of microlaparoscopy in the diagnosis of peritoneal and visceral adhesions and in the prevention of bowel injury associated with blind trocar insertion.

OBJECTIVE To determine the frequency of peritoneal and visceral adhesions to the umbilical region according to past surgical history and to estimate the risk of bowel injury with blind insertion of the principal trocar-cannula. DESIGN Prospective, unicentric study by a single operator. SETTING Clinique Saint-Sernin and Polyclinique de Bordeaux, Bordeaux, France. PATIENT(S) Eight hundred fourteen patients undergoing diagnostic or operative laparoscopy were classified into four groups based on their history of abdominal surgery: group I (n = 469), no previous abdominal surgery; group II (n = 125), prior laparoscopic surgery; group III (n = 131), previous laparotomy with a horizontal supra-pubic incision; group IV (n = 89), previous laparotomy with a midline incision. INTERVENTION(S) Initial microlaparoscopy performed through the left upper quadrant of the abdomen, inspection of the anterior abdominal wall and particularly the umbilical area for the presence of adhesions. Patients who had adhesions were assessed as to whether or not they were at significant risk of injury from blind insertion of the principal trocar. MAIN OUTCOME MEASURE(S) Incidence of umbilical adhesions and the potential risk of bowel injury with blind insertion of the umbilical (principal) trocar. RESULT(S) Umbilical adhesions were found in 9.82% of the 814 cases. The rates of umbilical adhesions were as follows: group I, 0.68%; group II, 1.6%; group III, 19.8%; and group IV, 51.7%. Severe adhesions with potential risk of bowel injury with blind insertion of the umbilical trocar in the four groups were 0.42%, 0.80%, 6.87%, and 31.46%, respectively. CONCLUSION(S) Women with previous laparotomy have a higher incidence of umbilical adhesions, especially in case of midline incision. Preliminary inspection of the umbilical area with a microlaparoscope and insertion of the umbilical trocar under direct vision are recommended for patients at risk for adhesions to reduce complications associated with insertion of the principal (umbilical) trocar.

Female fertility and donor insemination

Artificial insemination with donor semen (AID) frozen in 025-ml straws yielded an overall pregnancy rate of 64% in a series of 131 patients. The pregnancy rate was significantly higher in patients whose husbands were azoospermic (70%) than in women whose husbands were severely subfertile (48.8%) ( P

Coculture of embryos on homologous endometrial cells in patients with repeated failures of implantation

OBJECTIVE To evaluate the value of coculture of embryos on endometrial cells in patients with repeated failures of implantation. DESIGN A retrospective comparison of pregnancy rates between IVF-ET with coculture and standard culture methods. PATIENTS Ninety patients with repeated failures of transfer (range 4 to 11) underwent IVF-ET for a variety of disorders. METHOD Embryos were cocultured on homologous endometrial cells and transferred on day 4 after retrieval of oocytes. RESULTS The overall pregnancy rate for these patients was 21% per transfer versus 8% in previous IVF-ET cycles. A higher percentage (28%) was obtained for women < 39 years of age or on transfer of at least one morula (32.5% pregnancy per transfer). CONCLUSION Coculture of embryos on homologous endometrial cells is both safe and ethical. It appears to be a valuable approach for the selection of a good quality embryo before transfer. The technique should prove to be of benefit to patients with repeated failures of implantation and also may be of value for assessing the respective responsibility of endometrium and embryo in these repeated failures. However, the mechanisms underlying this improvement need to be determined to simplify the procedure.

A randomized, placebo-controlled, dose-ranging trial comparing fulvestrant with goserelin in premenopausal patients with uterine fibroids awaiting hysterectomy

OBJECTIVE To compare the use of a new antiestrogen fulvestrant with goserelin in reducing uterine fibroid growth before hysterectomy. DESIGN An international, multicenter, randomized, placebo-controlled study. SETTING Departments of obstetrics and gynecology. PATIENT(S) Premenopausal women (n = 307) diagnosed with uterine fibroids requiring hysterectomy. INTERVENTION(S) Over a 12-week period, patients received fulvestrant (50 mg, 125 mg, or 250 mg) as an i.m. injection, goserelin (3.6 mg) as a s.c. injection, or an injection-matched placebo once every 4 weeks. Patients underwent a hysterectomy at week 13. MAIN OUTCOME MEASURES Efficacy endpoints included changes in fibroid growth, endometrial thickness, and uterine volume. The excretion of urinary markers of bone resorption was also examined. RESULT(S) Goserelin significantly reduced fibroid growth and endometrial thickness compared with placebos. Fulvestrant did not significantly alter fibroid volume or endometrial thickness or change endpoints such as endometrial histology or vaginal bleeding. Fulvestrant was associated with fewer postmenopause-related adverse events than goserelin. Goserelin, but not fulvestrant, significantly increased markers of bone resorption. CONCLUSION(S) At doses equivalent to those used for the treatment of breast cancer in postmenopausal women, fulvestrant did not significantly inhibit fibroid growth and, of particular note, did not lead to bone resorption.

Premature ovarian failure: Report of seven cases

Abstract Seven young women, in whom premature menopause occurred at between 14 and 25 years of age, are the subject of this report. In 3, rudimentary types of ovarian streaks were found probably representing a forme fruste of gonadal dysgenesis. The chromosomal nuclear sex was positive in 6 and the karotype was normal in 5 of the 7 in which these tests were performed. In 2, the ovaries were typical of the corrugated wrinkled ovaries of the postmenopausal woman. It may be that the premature ovarian failure was due to poor endowment of primordial follicles or other factors presently poorly understood.

Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™

OBJECTIVE The objective of this multicenter, randomized study was to investigate the efficacy of the hydrophilic resorbable film PREVADH™ in preventing postoperative adhesions following myomectomy. STUDY DESIGN Women scheduled for laparotomic myomectomy with intramural and/or subserous myomas of >60mm in diameter, and who wished to preserve fertility, were eligible. Patients were randomized immediately prior to abdominal wall closure to receive either hydrophilic resorbable film applied directly to the incisions (P-Group, n=33) or 500mL Ringers lactate solution instilled into the pelvic cavity (R-Group, n=28). Incidence, severity, and extent of postoperative adhesions to the uterine incisions and adnexal and abdominopelvic adhesions were assessed during second-look laparoscopy 10-20 weeks after the initial surgery. Unedited videotapes of this second-look procedure were reviewed by two blinded independent surgeons. RESULTS Fifty-four patients (P-Group, n=28; R-Group, n=26) underwent second-look laparoscopy. Significantly fewer P-Group patients developed adhesions to uterine incisions than R-Group patients (43% vs. 92%, P=0.001). Adhesions, which were confirmed by independent reviewers, were found in significantly fewer P-Group sites than R-Group sites (29% vs. 76%, P=0.001). No serious adverse events related to the barriers used or adhesion-related complications were reported in either group. CONCLUSION The hydrophilic resorbable anti-adhesion film PREVADH™ significantly reduced adhesion incidence and severity after laparotomic myomectomy. CLINICAL TRIAL REGISTRATION NCT01388907 (www.clinicaltrials.gov).

Current thoughts on the management of dysfunctional uterine bleeding

Abstract Eighty-five private patients, affected by uterine bleeding, were studied and treated by employing norethindrone acetate-ethinyl estradiol combination. Three different regimens of therapy were tried. Hemostasis was readily achieved in almost all but a few instances. The availability of potent progestogens now permits a conservative management of dysfunctional uterine bleeding eliminating the need for repeated curettage or surgical interference.

Les adhérences pelviennes : impact et prévention

Les adherences pelviennes sont a la fois une source d’infertilite, d’echecs de la chirurgie de l’infertilite, de douleurs pelviennes chroniques, d’occlusion sur bride et de complication en cas de reintervention. Leur frequence est souvent sous-estimee car leur repercussion clinique est decalee dans le temps. Leur prevention repose d’abord sur une technique chirurgicale appliquant en cœlioscopie les regles de la microchirurgie, incluant une manipulation atraumatique, une hemostase soigneuse – mais une limitation de la coagulation – et une irrigation du champ operatoire. L’insufflation avec du CO2 humidifie et rechauffe est aussi un element important. La prevention par des agents pharmacologiques generaux n’a pas ete prouvee. La prevention par des agents locaux type barrieres solides, liquides ou gel manquent encore de preuve irrefutable de leur efficacite, et celle-la semble de toute facon modeste ; aussi ne doivent-ils venir qu’en complement d’une technique chirurgicale rigoureuse. Il est surtout necessaire que des etudes cliniques plus importantes soient realisees pour evaluer leur niveau d’efficacite.