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The impact of hydrosalpinx on successful pregnancy in tubal factor infertility treated by in vitro fertilization.

OBJECTIVE: To determine the impact of hydrosalpinx on pregnancy rates in patients undergoing IVF for infertility caused by tubal disease. DESIGN: Review of the records of all patients who had undergone IVF for tubal factor infertility at our institution between May 1988 and October 1994. SETTING: A university-sponsored, hospital-based IVF facility. PATIENT(S): Two hundred fifty patients were identified with infertility due to tubal disease; 67 of these had at least one documented hydrosalpinx whereas the remaining 183 did not. MAIN OUTCOME MEASURE(S): Numbers of oocytes retrieved and fertilized, the number of embryos transferred and implanting, and resulting pregnancy rates. RESULT(S): The groups were similar in age and cycle cancellation rates. The patients with hydrosalpinx had greater numbers of oocytes retrieved per cycle (15.0 versus 11.6) and embryos transferred per cycle then those without hydrosalpinges (4.21 versus 3.98). The hydrosalpinx group also undertook more cycles per patient (2.31 versus 1.96). Fertilization rates between the two groups were similar, but implantation rates were decreased in those with hydrosalpinx (8.5% versus 11.2%). CONCLUSION(S): Hydrosalpinx did not result in impaired ovarian stimulation or decreased oocyte fertilization. It did, however, interfere with implantation and reduce to some degree the success of IVF in achieving an ongoing pregnancy. The validity of routine salpingectomy for hydrosalpinx is debatable, but its use in selected individuals may well be appropriate.

Abortion, Spontaneous↗

Early nuclear events of in vitro fertilization in the domestic fowl (Gallus domesticus).

In vitro fertilization in the domestic fowl (Gallus domesticus) was investigated by observation of the early nuclear events. Ova retrieved from the fimbria following ovulation were inseminated in vitro with 10(6)-10(7) spermatozoa in Dulbecco's modified Eagle's medium (DMEM) for 10 min and then further incubated in DMEM + albumen for 1, 2, 3, or 4 hr. These eggs were histologically examined by epifluorescent microscopy after staining with 4',6'-diamidino-2-phenylindole (DAPI). Nuclei of spermatozoa at various stages of transformation were observed in the ova incubated for 1-3 hr. Close pairing of two pronuclei, presumed to be male and female juxtaposition, was detected in ova incubated for 4 hr. These data provide direct evidence for the in vitro fertilization of fowl eggs and suggested that the early process of in vitro fertilization is comparable to that of in vivo fertilization.

Animals↗

Diagnostic and clinical features in azoospermia.

BACKGROUND AND OBJECTIVE: The recent advances in assisted fertilization and gamete micromanipulation techniques have enabled fertilization in some forms of azoospermia; for example, epididymal sperm aspiration in obstructive azoospermia. Therefore knowledge of the specific degree of testicular damage is of primary importance, since other clinical parameters, such as FSH plasma levels and testicular volume, do not discriminate between the different testiculopathies. In order to further characterize the specific testicular conditions present in azoospermia, we have examined a large group of azoospermic subjects on the basis of testicular cytological analysis obtained by fine needle aspiration. DESIGN AND PATIENTS: One hundred and twenty-two infertile, azoospermic men were studied by physical examination, FSH radioimmunoassay, testicular ultrasound examination and fine needle aspiration of the testes. Thirty-five infertile normozoospermic subjects were studied as controls. RESULTS: The cytological analysis identified five different sub-types in azoospermic subjects: I, Sertoli cell-only syndrome; II, hypospermatogenesis; III, spermatogonial and/or spermatocytic arrest; IV, spermatidic arrest; and V, normal germ line. The testicular volume was reduced in groups I and II, while the FSH plasma levels were increased in groups I, II and III, suggesting a primary role of spermatids in the control of FSH secretion. CONCLUSIONS: In azoospermic subjects, testicular cytological analysis permits the identification of different sub-types and this classification may be very important in determining therapy, particularly the choice between surgical treatment and the hypothetical use of assisted fertilization techniques by retrieval of epididymal or intratesticular spermatozoa or spermatids.

Adult↗

Quantified ultrastructural study of spermatozoa in unexplained failure of in vitro fertilization.

Failure of in vitro fertilization or very low cleavage rates may occur even though oocyte and semen parameters seem satisfactory. Quantified ultrastructural study of spermatozoa was performed in such cases of failure (n = 6) or low cleavage rate (< 20%; n = 4). Through 1 to 11 retrievals, the number of inseminated oocytes ranged from 14 to 145. The results were compared to those of six fertile men. Quantification was achieved by cataloguing cell defects of the spermatozoon heads and mid-/principal pieces of the flagella. Using the data from each specimen, the percentages of total cellular abnormalities in the head/mid-/principal pieces were established. At the level of the head overall percentages for six groups of defects were determined. The overall percentage of combined head abnormalities, defined as the presence of at least three of these six defects on the same spermatozoon head, was established. Statistical differences among control and patient groups were analyzed by nonparametric Mann-Whitney U test. The percentages of anomalies of the midpiece and of the principal piece were not significantly different between patients and controls. Motility assessed by spermogram was considered "functionally uncompromised." In eight patients the percentage of cell alterations of the head (93-100 vs 77.3 +/- 6.4%) and the percentage of combined anomalies of the head (78.1-100 vs 60.8 +/- 8.5%) were significantly different between patients and controls. In two cases, the percentages established for all head parameters considered were not globally different from those observed in controls. Thus in 8 cases of 10, electron microscopy with quantified analysis supplied valuable evidence about the poor quality of these sperm samples judged as normal under light microscopy and may provide an explanation for their impaired fertilizability.(ABSTRACT TRUNCATED AT 250 WORDS)

Fertilization in Vitro↗

Effect of highly purified urinary follicle-stimulating hormone on oocyte and embryo quality.

OBJECTIVE: To determine the effects of ovarian stimulation with highly purified urofollitropin on oocyte and embryo quality. DESIGN: Parallel randomized open-label clinical study. SETTING: Assisted reproduction centers. PATIENT(S): Two hundred sixty-seven infertile couples undergoing IVF/ICSI. INTERVENTION(S): All participants underwent standard down-regulation with GnRH analogue. One hundred thirty-three participants received highly purified urinary FSH and 134 controls received recombinant FSH. MAIN OUTCOME MEASURE(S): Primary end points were number of morphologically mature oocytes retrieved, embryo quality, and pregnancy and implantation rates. Secondary end points were: total number of days of FSH stimulation, total dose of gonadotropin administered, fertilization rate per number of retrieved oocytes, embryo cleavage rate, live birth and miscarriage rates, endometrial thickness and estradiol level on the day of hCG administration, cancellation rate, and incidence of moderate or severe ovarian hyperstimulation syndrome. RESULT(S): Pregnancy and implantation rates were nonsignificantly higher in the urinary FSH group than the recombinant FSH group (46.5% vs. 36.8% and 22.1% vs. 15.8%, respectively). The grade 1 embryo score was significantly higher in the urinary FSH group than the recombinant FSH (42.1% vs. 33.5%), and the live birth rate was nonsignificantly higher in the former group. CONCLUSION(S): Highly purified urinary FSH is as effective, efficient, and safe for clinical use as recombinant FSH.

Adult↗

In vitro fertilization following natural cycles in poor responders.

This prospective study was designed to examine the feasibility of natural cycle in vitro fertilization (IVF) in poor responders, and the clinical factors that may predict successful outcome. Twenty-two poor responders underwent IVF treatment with 44 unstimulated cycles. The results of the natural cycles were compared with those of the 55 low-response stimulated cycles of these patients during the 12 months prior to the study. Eighteen (82%) patients had at least one oocyte retrieved, while nine (41%) had at least one cycle with embryo transfer. Two (9%) patients each gave birth to a healthy term baby. These results are comparable with those of the stimulated cycles. Serum early follicular follicle stimulating hormone (FSH) level was found to be the only reliable predictor of oocyte recovery and overall outcome in each specific natural cycle. However, because of great variability in basal FSH levels among different cycles of the same patient, this is not a reliable predictor of outcome in future cycles. We conclude that poor responders are a unique group of patients who may benefit from natural-cycle IVF treatment.

Adult↗

[Association between ovarian stimulation regime and protein metabolism of patients undergoing IVF/ICSI therapy].

The aim of this study was to determine the relationship between the ovarian stimulation protocol (with HMG or FSH) after down-regulation with GnRH anologa and protein (total protein and albumin) as well as bilirubin and urea in serum. Furthermore, it was intended to find out the effect of these parameters on IVF/ICSI outcome. 50 patients were included in this study. All patients underwent controlled ovarian hyperstimulation for assisted reproduction therapy either with FSH (Gonal-F) or HMG (Menogon). Ovulation induction was induced by human chorionic gonadotrophine (HCG, Predalon) 10 000 IU i. m. The protein concentration (total protein, albumin) as well as bilirubin and urea concentrations were determined before down-regulation with GnRHa, at the beginning of ovarian stimulation with FSH or HMG, on the day of ovulation induction with HCG, during oocyte retrieval and fourteen days after embryo transfer. The age, body mass index and etiology of infertility showed no significant difference between patients stimulated with HMG or FSH. Total protein and albumin concentration decreased significantly (p=0.001) from 77.45 +/- 5.90 g/L and 47.02 +/- 3.41 g/L to 74.60 +/- 4.6 g/L and 45.04 +/- 2.39 g/L, respectively at the time of oocyte retrieval. Whereas, no significant change with bilirubin and urea concentration was observed. However, the mean concentration of total protein, albumin, bilirubin of patients who become pregnant was higher of those who did not. In conclusion, this study shows that total protein and albumin concentration in plasma decreased during the follicular phase significantly with the application of exogenous gonadotrophins and steroid hormones in comparison to the value before down-regulation. The mean value of total protein, albumin, bilirubin of patients who become pregnant was higher (but not significant) of those who did not. However, the high individual variation in the present results shows that these parameters are not useful as a predictor of IVF/ICSI outcome.

Blood Proteins↗

Production of steroids from human cumulus cells treated with different concentrations of gonadotropins during culture in vitro.

OBJECTIVE: To evaluate the output of E2 and progesterone produced by cumulus cells, derived from mature and immature oocytes, in culture medium. DESIGN: Prospective randomized study. SETTING: McGill Reproductive Center, Royal Victoria Hospital, McGill University, Montreal, Quebec, Canada. PATIENT(S): Twenty-one women, <38 years of age and with normal menstrual cycles, who were undergoing intracytoplasmic sperm injection for assisted reproduction. INTERVENTION(S): Culture medium with or without fetal bovine serum (FBS) supplemented with either a physiologic (75 mIU/mL) or a supraphysiologic (7,500 mIU/mL) concentration of gonadotropins. MAIN OUTCOME MEASURE(S): Comparison of steroid levels in culture medium. RESULT(S): Estradiol secretion was significantly increased in the culture medium with FBS supplemented with both concentrations of FSH alone compared with control. However, E2 secretion was inhibited by both concentrations of FSH with LH. The level of E2 was undetectable in the medium without FBS even after supplementation with both concentrations of FSH alone, hCG alone, and FSH with LH. Progesterone production was increased in the medium with FBS supplemented with FSH alone, hCG alone, and FSH with LH compared with control. There was no difference in progesterone levels in the culture medium without FBS supplemented with both concentrations of FSH alone and hCG alone compared with control. However, progesterone secretion was increased in the medium without FBS supplemented with a physiologic concentration of FSH with LH. CONCLUSION(S): Culture medium with FBS supplemented with a physiologic and a supraphysiologic concentration of FSH stimulates E2 secretion from cumulus cells derived from mature and immature oocytes. This suggests that it may be not necessary to add E2 to the culture medium for maturation in vitro of immature human oocytes retrieved from patients undergoing stimulated cycles.

Adult↗

Assisted hatching--a meta-analysis of randomized controlled trials.

PURPOSE: To conduct a meta-analysis of randomized controlled trials (RCTs) on assisted hatching. METHODS: One hundred sixty-five studies were retrieved from the literature, but only 13 of them fitted our selection criteria. The meta-analysis was conducted using the RevMan software with the Peto-modified Mantel-Haenszel method. RESULTS: Assisted hatching increases the pregnancy [OR (+/-95% CI) = 2.51 (1.91-3.29)], implantation [OR (+/-95% CI) = 2.38 (1.87-3.03)], and ongoing pregnancy rates [OR (+/-95% CI) = 2.65 (1.85-3.79)] significantly in poor prognosis patients undergoing IVF or ICSI. For patients with repeated IVF failures, the OR (+/-95% CI) were 2.84 (1.99-4.06) for pregnancy, 2.53 (1.85-3.47) for implantation, and 3.51 (2.12-5.82) for ongoing pregnancy rates, in favor of assisted hatching. CONCLUSIONS: Assisted hatching increases the pregnancy, implantation, and ongoing pregnancy rates significantly in patients with a poor prognosis undergoing IVF or ICSI, particularly those with repeated failures.

Female↗

Prospective randomized comparison of ovarian blockade with nafarelin versus leuprolide during ovarian stimulation with recombinant FSH in an ICSI program.

PURPOSE: A prospective study was conducted to compare the efficiency of ovarian blockade with nafarelin versus leuprolide in a population whose indication for assisted reproduction was the male factor METHODS: A total of 238 patients were assigned at random to two types of treatment: Group I (119 aspirations), nafarelin (Synarel, Searle), 200 microg by the nasal route twice a day, and Group II (119 aspirations), leuprolide acetate (Lupron, Abbott), 0.5 mg by the subcutaneous route once a day. Both types of blockade were started during the 2nd phase (21st day of the menstrual cycle) and were continued until the day of HCG (5,000-10,000 IU). All patients received a fixed dose of recombinant FSH for 7 days and on the 8th day of stimulation the doses started to be adapted according to ovarian response. RESULTS: Patients' age did not differ (p = 0.93) between Group 1 (34.1 +/- 3.79) and Group II (34 +/- 4.64). The number of oocytes retrieved from Group I (10.5 +/- 5.93) was also similar (p = 0.57) to that retrieved from Group II (10.2 +/- 6.36). In addition, there was no difference (p = 0.58) in the number of oocytes retrieved at Metaphase II between Group I (8.2 +/- 4.61) and Group II (7.9 +/- 5.2). Fertilization rates and embryo scores were similar (p = 0.81 and p = 0.25, respectively) for Group I (67.5% +/- 21.3 and 34.4% +/- 14.4) and Group II (68.1% +/- 23and32.2% +/- 14.7, respectively). Inaddition, pregnancy rates per puncture and per embryo transfer and implantation rates were similar for Group I (30.2, 31.3, and 16.2%, respectively) then compared with Group 11(24.4, 25.2, and 12.6%, respectively) (p = 0.38, p = 0.37, and p = 0.22, respectively). CONCLUSIONS: Implantation and pregnancy rates per puncture and per embryo transfer are not statistically significant in the nafarelin group when compared with leuprolide group.

Adult↗

Early unilateral follicular aspiration compared with coasting for the prevention of severe ovarian hyperstimulation syndrome: a prospective randomized study.

Thirty women undergoing in-vitro fertilization or intracytoplasmic sperm injection considered to be at high risk of ovarian hyperstimulation syndrome (OHSS) were randomly allocated to have early unilateral follicular aspiration (EUFA) (group 1) or coasting (group 2) when the serum oestradiol concentration was >6000 pg/ml and there were more than 15 follicles each of >/=18 mm diameter in each ovary. EUFA was performed in group 1 at 10-12 h after the human chorionic gonadotrophin (HCG) trigger injection and human menopausal gonadotrophin (HMG) were withheld for 4.9 +/- 1.6 days until serum oestradiol concentrations fell below 3000 pg/ml when HCG was administered. The mean total dose and duration of administration of HMG were similar in groups 1 and 2 (48.3 +/- 17.4 and 50.2 +/- 16.5 ampoules; 13.7 +/- 2.2 and 14.1 +/- 3.2 days respectively). The mean serum oestradiol concentrations (9911 pg/ml versus 10 055 pg/ml) and number of follicles (43.3 versus 41.4) seen in both ovaries on the day of HCG administration in group 1 and on the day coasting was commenced in group 2 were also similar. After coasting, the mean serum oestradiol concentration on the day of HCG administration in group 2 was lower than in group 1 (1410 pg/ml versus 9911 pg/ml; P < 0.001). The mean serum progesterone concentrations on the day of HCG administration in both groups were similar, and fell in all women in group 2. The mean number of oocytes retrieved and percentage of oocytes retrieved per follicle punctured was significantly higher in group 1 (15.4 +/- 2.1 versus 9.6 +/- 3.2, P < 0.001; 91.4 +/- 4.4% versus 28.3 +/- 3.7%, P < 0.001 respectively). The fertilization and embryo cleavage rates were similar in both groups. Clinical pregnancy was diagnosed in 6/15 (40%) patients in group 1 and in 5/15 (33%) patients in group 2, while four women in group 1 and three in group 2 developed severe OHSS.

Adult↗

Hyperreactio luteinalis despite the absence of a corpus luteum and suppressed serum follicle stimulating concentrations in a triplet pregnancy.

Hyperreactio luteinalis is characterized by moderate to marked cystic enlargement of the ovaries related to multiple theca lutein cysts and is associated with very high sex steroid concentrations. It is a rare condition especially in the first trimester. The case described below is believed to be the only case of hyperreactio luteinalis reported following frozen embryo transfer. This case provides an opportunity to gain further insight into the mechanism responsible for this unusual condition. The 30 year old woman demonstrated a slightly elevated LH/FSH ratio (5 and 3 mIU/ml respectively) and normal baseline androgen concentrations. Two years following oocyte retrieval she had a second frozen embryo transfer. The ovaries were normal size when the embryos were transferred and androgens were still normal. The ovaries did not begin to enlarge until 51 days from transfer. A dichorionic intrauterine pregnancy with monozygotic twins in the left gestational sac was seen. Eventually, 86 days from transfer, the ovaries enlarged to 145x103x116 mm right; and 83x95x117 mm left. Serum oestradiol was 30 078 pg/ml, beta-human chorionic gonadotrophin (HCG) 239 920 mIU/ml, serum progesterone >160 ng/ml, total testosterone 2254 ng/dl, free testosterone 42.3 pg/ml and androstenedione 7328 ng/dl. Throughout the first trimester, serum FSH was <1 mIU/ml. Thus, neither FSH nor a corpus luteum is necessary to initiate this syndrome.

Adult↗

Influence of spermatozoa characteristics on gamete intra-fallopian transfer procedures: analysis of results obtained utilizing normozoospermic, oligoasthenozoospermic and donor spermatozoa.

The objective of this study was to analyze the efficacy of the gamete intra-Fallopian transfer (GIFT) procedure in relation to spermatozoa characteristics. A total of 268 infertile couples enlisted for GIFT were categorized into three groups on the basis of semen characteristics in the husband. These included oligoasthenozoospermic men in 88 retrieval cycles (group 1), normozoospermic men in 116 cycles (group 2) and azoospermic partners who needed donor semen in 86 cycles (group 3). All female patients had ovarian stimulation and laparoscopic GIFT. Pregnancy rates were significantly higher with donor spermatozoa than with oligoasthenozoospermic or normozoospermic spermatozoa, i.e. 51.1% versus 15.9% (P < 0.001), and 32.7% (P < 0.005). Implantation rates were significantly higher with donor spermatozoa than with normo- or oligoasthenozoospermic spermatozoa (P < 0.01). These data suggest that GIFT does not give good results with male factor infertility. Donor cryopreserved semen gives higher pregnancy and implantation rates than normozoospermic semen, and GIFT with donor spermatozoa gives a good chance of pregnancy to couples previously treated with artificial insemination using donor semen.

Female↗

The effect of female age on the likelihood of a live birth from one in-vitro fertilisation treatment.

OBJECTIVE: To determine the chance of at least one live birth from one round of in-vitro fertilisation (IVF) treatment and the effect of the woman's age on that likelihood. DESIGN: Retrospective analysis of outcomes from IVF treatment that did not involve donated gametes, but which included embryos cryopreserved in the retrieval cycle. SETTING AND PATIENTS: All IVF patients (median age, 36 years; range, 22-48 years) who attended a private IVF clinic in Sydney for an egg retrieval between 1 January 1998 and 31 December 1998, and had embryo placements (fresh and cryostored) performed up to 30 June 2001. MAIN OUTCOME MEASURE: Independently audited live births surviving the neonatal period. RESULTS: 565 women had 648 egg retrievals during the period. The age of peak utilisation of IVF was 39 years. For women aged 34 years or less, the chance of a live birth from one round of egg retrieval and IVF treatment was 52.4% (95% CI, 47%-59%). For women aged 35-44 years, there was a linear decline in the live birth rate, and no babies were born from retrievals at age 45 years and over. There was an age-dependent rise in the frequency of miscarriages, from 10.5% (95% CI, 5%-18%) for women under 35 years, to 16.1% (95% CI, 9%-25%) for those 35-39 years, and 42.9% [95% CI, 24%-63%] for those over 40 years (P < 0.001). A third of the first births resulted from embryo transfers performed after a period of cryostorage. CONCLUSION: As fertility with IVF falls from the age of 34 years, and the age of peak IVF utilisation is 39 years, many Australian women are seeking IVF at an age when the likelihood of a live birth is reduced.

Abortion, Spontaneous↗

Criteria of a successful coasting protocol for the prevention of severe ovarian hyperstimulation syndrome.

BACKGROUND: The aim of this study is to report a large series of patients (n = 1223) at risk of developing ovarian hyperstimulation syndrome (OHSS) who underwent coasting. METHODS: Coasting started when the leading follicle reached 16 mm and continued until the estradiol (E2) level fell to 3000 pg/ml. RESULTS: The E2 level at the start of coasting was (mean +/ SD) 6408 +/- 446 and it fell to 2755 +/- 650 on the day of HCG injection, after (mean +/- SD) 2.89 +/- 0.94 days. The results were analysed according to the duration of coasting (< or = 3 days, group I: n = 983; >3 days, group II: n = 240). The number of oocytes retrieved was (mean SD) 16.45 +/- 6.25 and 14.93 +/- 6.01 in groups I and II respectively (P < 0.05). The fertilization rates were 63 and 65% in groups I and II respectively (P > 0.05). The implantation and clinical pregnancy rates were 26 and 52% in group I compared to 18 and 36% in group II respectively (P < 0.05). Severe OHSS occurred in 16 cases, which represented 0.13% of all stimulated cycles, and 1.3% of patients who were at risk of developing OHSS. CONCLUSIONS: Our protocol of coasting was an effective measure in the prevention of OHSS, without jeopardizing the ICSI outcome. Coasting for >3 days is associated with a moderate decrease in the pregnancy rate.

Adult↗

[In vitro fertilization program. Preliminary results].

Three infertile couples were submitted to in vitro fertilization and uterine embryo transfer (IVF+ET) and 7 to in vitro fertilization and pronuclear stage tubal transfer (IVF+PROST). In order to programmed menstruation Norethisterone, 10 mg daily, were administered during the cycle preceding the one of controlled ovarian hyperstimulation. In order to inhibit endogenous production of FSH and LH, leuprolide acetate, a Gn-RH agonist, was injected subcutaneously 1 mg daily during 6 days and 0.5 mg fowardly from the luteal phase of the cycle proceeding the one of hyperstimulation until the day of HCG administration. To achieve superovulation pure FSH (Metrodine), HMG (Pergonal) and HCG (Endocorion) were used. Oocyte retrieval was performed through transvaginal puncture under ultrasonographic control. For oocyte and embryo identification and classification, spermatozoa separation and capacitation and gamete insemination and incubation procedures habitual techniques were employed. Pronuclear embryo tubal transfer was performed through a laparoscope 17 hours after insemination and embryo transfer to the uterine cavity after 48 hours. Nine of 10 patients responded to gonadotrophin hyperstimulation and were submitted to ovarian puncture. 69 oocytes (7, per patient) were obtained, 59 (81.15% of which were mature. 74.55% of the inseminated oocytes fertilized. Two patients got pregnant: one, submitted to IVF+PROST, presently has a multiple pregnancy with triplets and the second, submitted to IVF+UT, had a missed abortion at 8 weeks of pregnancy.

Adult↗

Follicular flushing at oocyte retrieval: a reappraisal.

A survey of Australian assisted reproduction technique (ART) units revealed many (> 50%) use flushing of the follicle in addition to direct aspiration of the fluid during oocyte retrieval. The rationale is that flushing offers an advantage to the patient, with a larger number of oocytes being collected and thus a higher potential for pregnancy Following a complication in a patient, the medical staff determined that flushing might have been implicated. While this was later shown to be unfounded, the unit changed the method of oocyte collection, thus providing an opportunity historically to evaluate the differences between aspiration of follicular fluid alone or with additional flushing of each follicle. Thus the aim of this analysis was to test the hypothesis that aspiration alone does not effect the outcomes of ART with respect to oocyte numbers collected, their quality and subsequent fertilisation, or ultimate pregnancy rate in a large patient group (n = 2378). During the review period (1991-1993) the manufacturer of the aspiration needles; the pump and pressure used for aspiration; the staff involved in all procedures; and the premises, equipment and media used for oocyte collection and culture remained constant. Similarly the two patient groups did not differ in their demographics and physical characteristics. There was no difference (p > 0.5) in the number of oocytes collected, the number of embryos created or the pregnancy rate for that treatment cycle. There was also no significant difference between the two groups in fertilisation rates, irrespective of the type of treatment being used in vitro fertilisation (IVF), gamete intrafallopian transfer (GIFT) or intracytoplasmic sperm injection (ICSI)). The data presented in this paper are not prospective. They use historical comparison and are confounded by minor changes in ovarian stimulation protocols, but the conclusions are still valid. These data suggest there is no difference in the outcome of ART (from oocyte collection through to pregnancy rate) whether or not aspiration of follicles is accompanied by flushing. First principles of surgery advocate the shortest possible operating time, the simplest procedure and minimum amount of tissue handling as maxims for reducing complication. Therefore, as a routine, flushing would seem superfluous in ART.

Female↗

An open, randomized single-centre study to compare the efficacy and convenience of follitropin beta administered by a pen device with follitropin alpha administered by a conventional syringe in women undergoing ovarian stimulation for IVF/ICSI.

BACKGROUND: A pen device, similar to an insulin pen, has been recently marketed for the administration of follitropin beta in cartridges. A randomized controlled trial was performed to compare the efficacy and convenience of this pen device delivering follitropin beta with a conventional syringe delivering follitropin alpha. METHODS: A total of 200 patients needing IVF/ICSI treatment and willing to self-inject were enrolled in the study. All subjects had ovarian stimulation according to a long protocol and were randomized to the pen or the conventional syringe group during down-regulation by means of a computer-generated randomization list using random numbers. Patients were asked to fill in a daily local tolerance book after each injection. On the day of hCG the patients scored a Visual Analogue Scale (VAS) for pain and convenience. RESULTS: The average duration, total dose of recombinant FSH and number of cumulus oocyte complexes retrieved were 10.8/12.0 days (P = 0.001), 1880/2226 IU (P < 0.001) and 15.2/13.1 respectively in the pen device and conventional syringe groups; the presence of pain after the daily injection was significantly higher in the conventional syringe group (P = 0.027); the visual analogue scale score was similar for pain but significantly more convenient for the pen device (P < 0.001). The live birth rate per embryo transfer was 32.9 and 34.4% respectively in the pen device and conventional syringe groups. CONCLUSIONS: Self-injection with the pen device is safe and easy, more convenient and less painful for the patient, requires less FSH and shortens the treatment duration.

Adolescent↗