Monitoring of in vitro fertilization-embryo transfer cycles by ultrasound versus by ultrasound and hormonal levels: a prospective, multicenter, randomized study. Ultrasound-guided hydrosalpinx aspiration during oocyte collection improves pregnancy outcome in IVF: a randomized controlled trial.
To determine whether cycle monitoring using both serum E(2) and ultrasound findings yields superior clinical pregnancy rates during IVF-embryo transfer (ET) compared to monitoring with ultrasound alone.
                Prospective, randomized, multicenter, patient-blinded study.
                Four assisted conception units in the United Kingdom.
                Two hundred ninety-seven women believed to be normal responders undergoing IVF treatment.
                Patients were randomly allocated on day 7 of stimulation to one of the two hCG administration criteria: [1] the E(2)-to-follicle > or =11 mm ratio was between 250 and 500 pmol/L/follicle and at least 2 follicles reached a mean diameter of 18 mm or [2] at least 2 follicles reached a mean diameter of 18 mm and the endometrium thickness was > or =8 mm.
                Duration and cumulative dose of recombinant human FSH, total number of growing follicles, oocytes retrieved, number and quality of embryos, pregnancy rates, and ovarian hyperstimulation syndrome (OHSS) rates.
                Two hundred ninety-seven patients were randomized to one of the two criteria groups. Of these, 288 (97%) received urinary (u)-hCG (143 in group A and 145 in group B). One hundred three women in group A (72%) met both criteria for hCG administration. Pregnancy and OHSS rates were similar (34.3% vs. 31.4% and 4.9% vs. 4.1%, respectively).
                The addition of E(2)/follicle criteria to ultrasound monitoring of IVF cycles in normal responders seldom changes the timing of hCG, and does not increase pregnancy rates or the risk of OHSS. Hydrosalpinges have adverse effects on IVF outcomes. Salpingectomy is effective in improving outcomes, but it is not always practical or safe. Ultrasound-guided aspiration of hydrosalpinges at oocyte collection is an option for those who develop hydrosalpinges during controlled ovarian stimulation; however, there is no randomized evidence to show whether this practice is effective.
                Between October 1999 and June 2003, consenting women of age <or=39 years with an ultrasound diagnosis of hydrosalpinx were randomized before oocyte collection to transvaginal aspiration of hydrosalpinx under antibiotics cover or no aspiration. Third-party randomization was performed using a computer algorithm, and allocation concealment was achieved with opaque sealed envelopes. Outcomes were biochemical and clinical pregnancies, implantation, spontaneous abortion, ectopic pregnancy and pelvic infection rates. Analysis was by intention to treat.
                Sixty-six women were recruited to the trial, 32 to the aspiration group and 34 to the no-aspiration group. Aspiration resulted in a greater biochemical pregnancy rate [14/32 (43.8%) versus 7/34 (20.6%), relative risk (RR) = 2.1 (1.02, 4.6), P = 0.04]. Clinical pregnancy rates for aspiration versus control groups were 31.3% (10/32) and 17.6% (6/34), respectively [RR = 1.8 (0.8, 4.3), P = 0.20]. There were no changes in implantation rate or spontaneous abortion risk with aspiration and no differences between the groups in infection or ectopic pregnancy rates.
                In women who are identified to have hydrosalpinges during controlled ovarian stimulation during IVF, aspiration of hydrosalpinges during oocyte collection may be effective in improving pregnancy rates (Trial Registration Number: NCT00566956).
There is no evidence from randomised trials to support cycle monitoring by ultrasound plus serum estradiol as more efficacious than cycle monitoring by ultrasound only on outcomes of live birth and pregnancy rates. A large well-designed randomised controlled trial is needed that reports on live birth rates and pregnancy, with economic evaluation of the costs involved and the views of the women undergoing cycle monitoring. A randomised trial with sufficiently large sample size to test the effects of different monitoring protocols on OHSS, a rare outcome, will pose a great challenge. Until such a trial is considered feasible, cycle monitoring by transvaginal ultrasound plus serum estradiol may need to be retained as a precautionary good practice point.