Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group

Ovarian Stimulation Strategies for Intrauterine Insemination in Couples with Unexplained Infertility - A Systematic Review and Individual Participant Data Meta-analysis

Wessel JA et al., 2022 · Fertility & Reproduction · Free to read

Intrauterine insemination with ovarian stimulation (IUI-OS) is a first-line treatment for couples with unexplained infertility. Individual participant data meta-analysis (IPD-MA) is the gold standard for evidence synthesis. To compare the effectiveness and safety of ovarian stimulation with gonadotrophin, Letrozole and clomiphene citrate (CC) and to explore treatment-covariate interactions for important baseline characteristics in women undergoing IUI. We searched electronic databases including PubMed, MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL). We included randomised controlled trials (RCTs) comparing IUI-OS with gonadotropins, Letrozole or CC among couples with unexplained infertility. We excluded dose comparing studies of the same drug. We contacted the authors of eligible RCTs to share the IPD and established the IUI IPD-MA collaboration. The primary effectiveness outcome was live birth and the primary safety outcome was multiple pregnancy. We used a one-stage approach using a random effects model. Six RCTs (n= 2299) provided IPD. Gonadotropins increased the chance of a live birth compared to both CC (5 RCTs, 1946 women, RR 1.28, 95%CI 1.10 to 1.49, I2 = 25%, moderate-quality evidence) whereas there was insufficient evidence of a difference between Letrozole and CC (1 RCT, 599 women, RR 0.77 95%CI 0.58 to 1.03). Gonadotropins increased the risk of a multiple pregnancy compared to both CC (4 RCTs, 1696 women, RR 2.17, 95%CI 1.33 to 3.55, I2 = 69%, low-quality evidence) whereas there was insufficient evidence of a difference between Letrozole and CC (1 RCT, 599 women, RR 0.71, 95%CI 0.33 to 1.56). No strong evidence on the treatment-covariate interactions (female age, BMI or primary versus secondary infertility) was found. Gonadotropins increased the chance of a live birth compared to both CC and Letrozole but also increased the chance of a multiple pregnancy. Further RCTs comparing Letrozole and other interventions in couples with unexplained infertility are needed.

Surgical Techniques of Open Myomectomy

Freeman ML et al., 2002 · Operative Techniques in Gynecologic Surgery

Metaanalysis of the safety and efficacy of an adhesion barrier (Interceed TC7) in laparotomy

Wiseman DM et al., 1999 · J Reprod Med

To evaluate the safety and efficacy of an oxidized, regenerated, cellulose adhesion barrier (Interceed TC7) in the reduction of pelvic adhesions. Clinical studies published or completed by December 31, 1994, evaluating the barrier used at laparotomy were considered for a metaanalysis. Of 10 studies (n = 560) identified, data from 7 (n = 389) met the inclusion criteria for determining the reduction in the incidence of adhesions and 5 (n = 311) for determining the reduction in adhesion extent (raw surface area after adhesiolysis). There was a 24.2 +/- 3.3% difference in the incidence of adhesions (P < .001) between barrier-treated and untreated sites. Adhesion-free outcomes were 1.5-2.5 times more likely at barrier-treated sites than at sites with good surgical technique alone (odds ratio = 2.89; 95% confidence interval = 2.15-3.90). Barrier treatment resulted in a greater reduction (1.1 +/- 0.4 cm2) in adhesion extent (raw surface area) than good surgical technique alone (P < .001). Four adverse events were recorded; they were typical of those seen after surgery. No event was considered to be definitely related to the use of the barrier. The barrier significantly reduced the incidence and extent of adhesions as compared with no treatment, confirming the conclusion from individual studies that it is safe and effective in pelvic laparotomy surgery.

Assessment of carboxymethylcellulose and 32% dextran 70 for prevention of adhesions in a rabbit uterine horn model

Diamond MP et al., 1988 · Int J Fertil

The ability of solutions of carboxymethylcellulose (CMC) and 32% dextran 70 to reduce postoperative adhesion formation was examined using a rabbit uterine-horn scrape model. Utilization of 50 mL of 32% dextran 70 did not reduce adhesion formation compared with control rabbits. However, intraperitoneal instillation of CMC significantly reduced postoperative adhesion formation. An inverse correlation was established between either the concentration of CMC employed (1%, 2%, and 3%) or the volume of 2% CMC employed (20, 30, 40, and 50 mL) and the extent of adhesion formation. It is concluded that in this animal model CMC, but not 32% dextran 70, was able to retard postoperative adhesion formation.

An expanded polytetrafluoroethylene barrier (Gore-Tex Surgical Membrane) reduces post-myomectomy adhesion formation. The Myomectomy Adhesion Multicenter Study Group

Myomectomy Adhesion Multicenter Study Group, 1995 · Fertil Steril

To evaluate the effects of the expanded polytetrafluoroethylene barrier (PTFE), Gore-Tex Surgical Membrane, in reducing postmyomectomy adhesion formation. Multicenter randomized clinical trial. Twenty-seven women having myomectomy with at least two incisions on the uterine fundus and posterior uterine wall of similar length were enrolled in the study. At laparotomy, the two incision sites were randomly assigned to be covered with PTFE or were left uncovered. A second-look laparoscopy to evaluate adhesion formation and to lyse adhesions was done from 2 to 6 weeks after the myomectomy. Adhesions were scored using a 0- to 11-point scoring system. At laparoscopy, 15 of 27 incisions covered with PTFE (55.6%) and only 2 of 27 uncovered sites (7.4%) were completely free of adhesions. The mean adhesion score at the PTFE sites was significantly lower (1.88 +/- 0.46; SEM) than at the control sites (7.55 +/- 0.57). The PTFE barrier is effective in reducing postmyomectomy adhesion formation.

Prevention of de-novo adhesion formation after laparoscopic myomectomy: a randomized trial to evaluate the effectiveness of an oxidized regenerated cellulose absorbable barrier

Mais V et al., 1995 · Hum Reprod

To evaluate the effectiveness of the oxidized regenerated cellulose absorbable barrier (Interceed, TC7) in the prevention of de-novo adhesion formation after laparoscopic myomectomy, a prospective and randomized study was performed at the Department of Obstetrics and Gynaecology of the University of Cagliari, Cagliari, Italy. A total of 50 pre-menopausal non-pregnant women, aged 23-42 years, who submitted to laparoscopic myomectomy from January 1993 to June 1994, were randomized to surgery alone (control group, n = 25) or surgery and oxidized regenerated cellulose barrier (Interceed group, n = 25). Neither group received any other treatment for adhesion prevention. A second-look laparoscopy was performed 12-14 weeks after laparoscopic myomectomy. The incidence of adhesion-free patients was assessed at second-look laparoscopy by an investigator not informed of the treatment. The numbers of adhesion-free patients were three out of 25 (12%) in the control group and 15 out of 25 (60%) in the treatment group (P < 0.05). In conclusion, the oxidized regenerated cellulose absorbable barrier significantly reduced de-novo adhesion formation after laparoscopic myomectomy.

Reduction of postoperative pelvic adhesions with intraperitoneal 32% dextran 70: a prospective, randomized clinical trial

No Authors Listed, 1983 · Fertil Steril

Infertile women of reproductive age requiring an operation for distal tubal disease, endometriosis, or pelvic adhesions were recruited from nine study centers. Prior to closing the peritoneal cavity, 250 ml of 32% dextran 70 (n = 55) or saline (n = 47) was instilled into the dependent portion of the pelvis; 8 to 12 weeks later, laparoscopy was performed on those patients not pregnant. Patients with severe adnexal adhesions at the initial laparotomy had a greater reduction in adhesions if they received 32% dextran 70. Further, patients with a marked reduction in adhesion formation following the initial laparotomy were found to occur more frequently in the 32% dextran 70-treated group (26 of 51 for 32% dextran 70 versus 12 of 40 for saline; P less than 0.05). During second-look laparoscopy, adhesions were found to occur more frequently in control patients than in 32% dextran 70-treated patients at the following anatomic sites: ovary (P less than 0.05); cul-de-sac (P = 0.017); pelvic side wall (P less than 0.001). Thus, in a prospective, randomized, blinded clinical trial, the intraperitoneal high-molecular-weight dextran was found to reduce postoperative adhesion formation effectively.

Reduction of ovarian adhesions by the use of Interceed. Ovarian Adhesion Study Group

Franklin RR, 1995 · Obstet Gynecol

To evaluate the efficacy of Interceed (TC7) Absorbable Adhesion Barrier, an oxidized regenerated cellulose fabric, as a barrier to the development of postsurgical ovarian adhesions after surgery involving the ovaries. In a multicenter randomized study, 55 patients with bilateral ovarian disease were treated at initial laparotomy. At the end of the procedure, one ovary was assigned randomly to be wrapped with Interceed and the other was left uncovered. A second-look laparoscopy was performed 10-98 days later to evaluate the occurrence and severity of adhesions and the raw ovarian surface area exposed after lysis of adhesions. At second-look laparoscopy, 26 of 55 Interceed-treated ovaries were free of adhesions, compared with 14 of 55 untreated control ovaries, a statistically significant difference (P = .028, Fisher exact test). At second-look laparoscopy, ovaries treated with Interceed formed adhesions less extensively (1.66 +/- 0.34 cm2) than did untreated ovaries (2.75 +/- 0.60 cm2) and with a greater reduction of raw ovarian surface area (difference in area differential -1.89 +/- 0.96 cm2; P = .055, paired t test). Adhesion scores at second-look laparoscopy were reduced significantly for ovaries treated with Interceed compared with untreated ovaries (P = .02, Wilcoxon signed-rank test). No adverse events were recorded during the course of the study. Treatment of ovaries with Interceed significantly reduced the occurrence and severity of postsurgical ovarian adhesions.