Department of Obstetrics and Gynecology, Faculty of Medicine, Tokyo Medical and Dental University, Tokyo 113, Japan
Recently, in-vitro fertilization (IVF) and embryo transfer have been considered to be the standard treatment for tubal factor infertility. It has also been used to treat couples with male infertility for over a decade, with relatively disappointing results (Palermo et al., 1995). The pregnancy rate of IVF/embryo transfer has steadily increased since the birth of the first baby in 1978 (Society for Assisted Reproductive Technology, 1991). However, for the past few years, the pregnancy rate following conventional IVF has remained steady (Society for Assisted Reproductive Technology, 1998). The introduction of intracytoplasmic sperm injection (ICSI) (Palermo et al., 1992
) and the high fertilization and pregnancy rates reported (Van Steirteghem et al., 1993
) have established it as the main method for the treatment of male infertility. Since IVF and embryo transfer techniques have been improved and simplified, they are now being practised on an outpatient basis, both in Japanese hospitals and in office-based gynaecological practices. An increase in the numbers of patients demanding IVF/embryo transfer treatment, simplified monitoring of follicular growth by intravaginal ultrasonography, and the improvement of gonadotrophin stimulation methods combined with the use of gonadotrophin-releasing hormone (GnRH) agonists have made this new system more popular. However, there are still some problems that must be overcome and side-effects that must be prevented. During 1997, we conducted a randomized study in Japan to evaluate the advantages and disadvantages of practising of IVF/embryo transfer on an outpatient basis, in comparison with conventional IVF on an admission basis.
Questionnaire regarding IVF/embryo transfer on an outpatient basis in Japan
Here, we report the data obtained in response to a questionnaire which was sent randomly to gynaecological outpatient clinics and the gynaecology departments of hospitals in Japan. The questionnaire was divided into several categories for evaluating the feasibility of IVF on an outpatient basis, concerning: (i) egg retrieval; (ii) embryo transfer; (iii) statistical studies of IVF; and (iv) doctors' comments on the methods. It included 25 questions (mainly multiple choice), concerning the size of the clinical staff in outpatient wings and recent clinical problems encountered during the practice of IVF on an outpatient basis. We also asked for comments on the future prospects of this new system. We selected 100 clinical institutes at random that actively pursue an IVF programme for the treatment of infertile patients, and mailed the questionnaire to them. The questionnaires were answered by 24 university hospitals, 25 city hospitals and 31 office-based gynaecological practices; a total of 80 institutes. Among them, 47 clinics (20 hospitals and 27 office-based practices) performed both egg retrieval and embryo transfer on an outpatient basis, six clinics (four hospitals and two office-based practices) carried out egg retrieval on an outpatient basis and embryo transfer on an admission basis, seven clinics (all hospitals) performed embryo transfer on an outpatient basis and egg retrieval on an admission basis, and 20 clinics (18 hospitals and two office-based practices) performed both on an admission basis.
We attempted to obtain information on the advantages and disadvantages of the practice of IVF on an outpatient basis compared with that on a conventional admission basis, whether or not the entire process of IVF was performed on an outpatient basis at their respective institutes, and sought the comments of practising physicians who are experts in this field.
Statistics of IVF treatment practised on an outpatient basis in Japan
Of the 53 clinics which performed egg retrieval on an outpatient basis, 32% carried out more than 20 cases of egg retrievals/month, 19% carried out between five and eight cases/month, 13% carried out 912 cases/month, 7.5% carried out 1720 cases/month, 7.5% carried out 1316 cases/month, and 21% carried out less than four cases/month on an outpatient basis. Of the same 53 clinics, 72% used the same methods to stimulate ovulation using human menopausal gonadotrophinhuman chorionic gonadotrophin (HMGHCG) as those on an admission basis; in contrast, 28% used modification of the conventional methods performed in admitted patients; e.g. they used a smaller amount of HMG to avoid ovarian hyperstimulation syndrome (OHSS; 73%), or they made schedules for ovulation stimulation to avoid egg retrieval on a day off. In addition, we recorded the schedule for egg retrieval on a regular week day. A total of 58% of doctors performed egg retrieval on an outpatient basis in the morning before beginning clinical work, 28% carried it out during clinical work during the daytime, 15% carried it out in the evening after finishing clinical work and 15% carried it out on a flexible basis (multiple selection was possible). The methods used for anaesthesia were simplified i.v. anaesthesia or modified anaesthesia using a minor tranquillizer, barbiturate or pentazocine in 57%, local anaesthesia in 31%, and no anaesthesia in 19% (multiple selection possible). After egg retrieval on an outpatient basis, 42% of patients were observed for <3 h, 45% for 35 h, 9% for 68 h and 4% for >8 h. With regard to the timing of egg retrieval, 42% of doctors carried out egg retrieval every day in regardless of holiday or days off, 18% sometimes carried it out on a holiday, and 40% never performed it on a holiday. The doctors considered the advantages of egg retrieval on an outpatient basis to be: (i) lower cost (90%); (ii) reduced psychological stress for the patient (67%); (iii) simpler procedures and preparation for treatment (60%); (iv) no beds for admission required (55%); (v) fewer medical staff required (16%); and (vi) communication between the doctor and patient was improved (9%) (multiple selection was possible). HCG was injected into the patients either at outpatient clinics (90%) or by the patients at home (10%), 3236 h before the egg retrieval was carried out.
In the 54 clinics which performed embryo transfer on an outpatient basis, all doctors carried this out 2 days after insemination; 57% performed embryo transfer during clinical work in the daytime, 28% carried it out on a flexible schedule, 13% carried it out in the morning before beginning clinical work, and 11% carried it out in the evening after finishing clinical work (multiple selection). In regard to the location for egg retrieval and embryo transfer, >90% of the doctors performed embryo transfer in operation rooms or special treatment rooms for IVF, and only 7% used the regular space in the outpatient clinic. 77% of the clinics who practised IVF on an outpatient basis replied that their average success rates for implantation and pregnancy were almost the same as the rates obatined on an admission basis, 6% reported higher success rates and only 4% reported a lower success rate for IVF on an outpatient basis than on an admission basis. The remaining 13% gave no response on this point.
In the 60 clinics which performed IVF/embryo transfer (including egg retrieval only or embryo transfer only) on an outpatient basis, 40% had more than five staff members assisting in the procedures, 33% had four, 17% had three, and 10% had two staff. Of these 60 clinics, 58% (72% of office-based gynaecological practices), hired specialist staff for embryo transfer only, and the percentage of office-based gynaecological practices was higher than at hospitals performing embryo transfer on an outpatient basis. In these 60 clinics, 79% performed ICSI.
Problems and side-effects of outpatient IVF
We sought to document experiences of severe side-effects during the IVF procedure on an outpatient basis; 66% reported OHSS, 33% reported severe intra-abdominal bleeding following egg retrieval, 11% reported heavy vaginal bleeding following egg retrieval, and several doctors reported other symptoms. However, in the clinics where IVF was performed on an outpatient basis, 80% commented that the method was almost as safe as that performed on a conventional admission basis. With regard to the problems of the practice of IVF performed on an outpatient basis, 65% of the clinics answered that there were no problems with this method, 17% reported that OHSS was more easily overlooked, and 13% answered that the time of the IVF procedure was restricted (Figure 1A). In contrast, in clinics where IVF was performed on an admission basis, 93% commented that OHSS was easier to overlook following IVF on an outpatient basis, and 36% pointed out that the time of the IVF procedure was restricted, compared with that on an admission basis (Figure 1B
) (multiple selection).
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Future prospects of IVF on an outpatient basis
We sought some comments on the future of the practice in IVF/embryo transfer on an outpatient basis from the questionnaires. Among the clinics doing it on an outpatient basis, 81% predicted that this practice will become more popular and the main setting for IVF. In the clinics practising IVF on an admission basis, the same opinions were given but by a smaller percentage (41%), and 17% of them think that improvements of the practice of IVF on an outpatient basis will be needed. It is important to identify and overcome the problems associated with such practice as soon as possible. Comments were sought on improved methods in the practice of IVF on an outpatient basis. The results were as follows (multiple selection): improvement in methods used for ovulation induction (38%), that of IVF staff or staff arrangements (28%), that of anaesthesia (23%), improvement of follicular monitoring (19%), that of the embryo transfer technique (13%), that of the ICSI technique (13%), that of culture systems and instruments including culture medium (9%), and that of egg retrieval methods (8%).
The present study revealed that 77% of clinics which perform IVF on an outpatient basis have four or more staff for IVF including staff specially trained for assisted reproductive technology. Nowadays, office-based gynaecological practices may perform more effective IVF because they can more easily hire specialized staff compared with the large-sized hospitals in Japan. In future, it is necessary to systematize and train specialized staff for outpatient IVF practice in order to master the technique and/or the knowledge of reproductive endocrinology or biology. On the other hand, since obstetrics and gynaecology specialists of outpatient clinics in city or the university hospitals in Japan are very busy due to the large number of patients and small number of medical staff including nurses, they cannot perform IVF efficiently on an outpatient basis. Additionally, it is more difficult for the doctors in hospitals to arrange IVF treatment systematically on days off and holidays. Therefore, this new method can be developed for office-based practice or private practice for the treatment of patients. Transport IVF system, that is, the transportation of oocytes or embryos from outpatient clinics to IVF laboratories in affiliated hospitals will also come more accessible to infertile patients in the near future (Jansen et al., 1986; Verhoeff et al., 1992
).
The security of retrieved eggs or embryo will be important because the outpatient practice of IVF would be busier and is more widely available to the patients than the conventional method. At the same time, we must pay attention to the ethical problems that may arise from complicated social conditions in future. Finally, it is necessary to consider high-risk pregnancies which will be encountered more frequently due to an increase in the practice of IVF. Close association will be needed between office-based gynaecological practice and the central hospitals in the same district.
Conclusions
We report the results of a questionnaire survey of randomly selected gynaecological outpatient clinics and hospitals, and the actual status of the practice of IVF on an outpatient basis in Japan in 1997. The average success rate of the egg retrieval, implantation and pregnancy in the outpatient practice of IVF were almost same as those associated with IVF on an admission basis. In clinics where embryo transfer is performed on an outpatient basis, 80% of doctors comment that the method is almost as safe as that carried out on an admission basis. These results predict that the new method will become more popular and will be the main mode of practice of IVF in future. The method is very attractive for the treatment of infertile patients, and the need for the practice of IVF on an outpatient basis is increasing in Japan. However, there are still some problems that must be overcome and side-effects that must be prevented.
Notes
1 To whom correspondence should be addressed
This Opinion was previously published on Webtrack 66, May 24, 1999
References
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