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PubMed1989

Evaluation of endocrine parameters and semen samples: pregnancies following conservative infertility treatment versus IVF therapy.

IVF techniques have recently attracted interest as a possible treatment of male subfertility. In order to clarify if semen profiles of men fathering a child after IVF differ significantly from those patients initiating a pregnancy after timed intercourse or AIH, we retrospectively compared sperm parameters in 67 males whose female partners were treated by IVF with those of 102 couples treated conservatively. In all male partners stimulation tests for FSH and LH, TSH and prolactin (PRL) had been performed as well as measurement of testosterone (T) levels. No significant differences were revealed for mean values of any of the classical semen parameters: volume, concentration, vitality, motility, normal morphology and results of the hypoosmotic swelling test between groups for men initiating a conception. Endocrine evaluation of the male patients detected no major hormonal imbalances associated with specific subnormal sperm parameters although regression analyses demonstrated relationships between semen volume and TSH as well as T, and between sperm concentration and PRL as well as FSH levels. We conclude that IVF techniques are not superior to cycle optimization with timed insemination in the treatment of andrological subfertility.

Female↗
PubMed2003

Fertility preservation in breast cancer patients: IVF and embryo cryopreservation after ovarian stimulation with tamoxifen.

BACKGROUND: Breast cancer chemotherapy commonly causes premature ovarian failure and infertility. Because increased estrogen levels are thought to be potentially risky in breast cancer patients, natural cycle IVF (NCIVF) has been used to preserve fertility and treat infertility in these women. METHODS: Twelve women with breast cancer received 40-60 mg tamoxifen for 6.9 +/- 0.6 days beginning on days 2-3 of their menstrual cycle (15 cycles), and had IVF (TamIVF) with either fresh embryo transfer (six cycles) or cryopreservation (nine cycles). They were compared to a retrospective control group (n = 5) who had natural cycle IVF (NCIVF, nine cycles). RESULTS: Cycle cancellation was significantly less frequent in TamIVF, compared with NCIVF (1/15 versus 4/9, P < 0.05). Compared with NCIVF, TamIVF patients had a greater number of mature oocytes (1.6 +/- 0.3 versus 0.7 +/- 0.2, P = 0.03) and embryos (1.6 +/- 0.3 versus 0.6 +/- 0.2, P = 0.02) per initiated cycle. TamIVF resulted in the generation of embryo(s) in every patient (12/12) while only three out of five patients had an embryo following NCIVF. Two out of six patients in TamIVF, and 2/5 in NCIVF conceived. One patient in the TamIVF group delivered a set of twins. After a mean follow up of 15 +/- 3.6 months (range 3-54), none of the patients had a recurrence of cancer. CONCLUSIONS: Tamoxifen stimulation appears to result in a higher number of embryos and may provide a safe method of IVF and fertility preservation in breast cancer patients.

Adult↗
PubMed2003

Endometrial integrin expression in women undergoing IVF and ICSI: a comparison of the two groups and fertile controls.

BACKGROUND: Integrins are thought to play a vital role in implantation. Three integrins in particular (alpha(4)beta(1), alpha(v)beta(3) and alpha(1)beta(1)) are all present during the implantation window. Defects in their expression have been linked to tubal disease, unexplained infertility and endometriosis. Hence, a reduced endometrial integrin expression would be expected in women attending for IVF due to these causes of infertility when compared with those with male factor infertility attending for ICSI. METHODS: Women attending for IVF (n = 25) and ICSI (n = 25) treatment were recruited, and timed endometrial biopsies were taken during the 'implantation window' (cycle day 20-24). A group of fertile women (n = 15) attending for sterilization was used as controls. RESULTS: There was no significant difference in integrin expression between patients undergoing IVF or ICSI. Neither did these groups differ from the control group. CONCLUSIONS: The endometrium in patients undergoing ICSI treatment is sometimes thought to be more receptive, as the infertility might be due to a male factor. This study shows that there is no significant difference in integrin expression between patients attending for IVF or ICSI and the control group. These data add to the increasing uncertainty about the clinical value of assessing the endometrium with only one marker, in this case integrins.

Adult↗
PubMed2003

The IVF league tables: time for a reality check.

In many countries the reported results of the different IVF clinics are published nationally by the relevant regulatory bodies, such as the Human Fertilisation and Embryology Authority in the UK. The published format suggests that clinics are being compared on a valid basis, and the involvement of the regulatory bodies apparently gives this comparison the official seal of authenticity. However, clinics can control many factors in patient selection, management and reporting, and these can inflate the reported results. Consequently, patients, instead of being appropriately guided, can be misled by these so-called "IVF league tables". The IVF community, including users, providers and regulatory bodies, need to recognize these factors and to develop a way forward for comparing clinics results on an equal and a valid basis. In this paper we discuss the factors that could affect the reported IVF results, and suggest possible options for valid comparison.

Female↗
PubMed2003

Increased T helper 1 cytokine responses by circulating T cells are present in women with recurrent pregnancy losses and in infertile women with multiple implantation failures after IVF.

BACKGROUND: We aimed to study T-helper 1 (Th1) and Th2 intracellular cytokine expression in peripheral blood lymphocytes of women with recurrent spontaneous abortions (RSA) or infertility with multiple implantation failures after IVF cycles. METHODS: Twenty-six women with three or more RSA and 23 with two or more IVF failures (14 with no history of spontaneous abortion (SAB) and nine with more than one SAB) comprised the two study groups. Twenty-one non-pregnant healthy multiparous women served as controls. Proportions (%) of lymphocytes containing IFN-gamma, TNF-alpha, IL-4 and IL-10 and the Th1/Th2 ratios of IFN-gamma/IL-4, IFN-gamma/IL-10, TNF-alpha/IL-4 and TNF-alpha/IL-10 in CD3+, CD3+/CD8- (T helper) and CD3+/CD8+ (T suppressor) cells were measured by 4-colour flow cytometry. RESULTS: RSA women demonstrated significantly higher Th1/Th2 ratios of IFN-gamma/IL-4 (P < 0.01), TNF-alpha/IL-4 and TNF-alpha/IL-10 (P < 0.05 each) in CD3+/CD8- T helper cells than those of controls. The proportion of TNF-alpha producing CD3+/CD8- cells (P < 0.05), and the Th1/Th2 ratios of TNF-alpha/IL-4 (P < 0.05) and TNF-alpha/IL-10 (P < 0.005) in CD3+/CD8- cells were significantly higher in women with multiple IVF failures without SAB as compared with those of controls. CONCLUSIONS: The prevalence of dominant Th1 immune responses in peripheral blood lymphocytes may reflect the systemic contribution of Th1 cytokines to RSA or multiple implantation failures in IVF cycles.

Abortion, Habitual↗
PubMed2003

Morbidity in a Danish national cohort of 472 IVF/ICSI twins, 1132 non-IVF/ICSI twins and 634 IVF/ICSI singletons: health-related and social implications for the children and their families.

BACKGROUND: There is a lack of knowledge on child health as well as family well-being in IVF/ICSI twins. METHODS: These data originated from questionnaires completed by mothers taking part in a national cohort study of twin and singleton births occurring in Denmark in 1997. The overall response rate was 83%. The three cohorts consisted of all IVF/ICSI twin children (n = 472), all IVF/ICSI singletons (n = 634) and all non-IVF/ICSI twin children (n = 1132) born in Denmark in 1997. RESULTS: No major differences in physical health were observed between IVF/ICSI twins and non-IVF/ICSI twins. Compared with IVF/ICSI singletons, more IVF/ICSI twins were admitted to a neonatal intensive care unit (NICU) (P < 0.01) and more had surgical interventions (P = 0.03) and special needs (P = 0.02), moreover they had poorer speech development (P < 0.01). Correspondingly, IVF/ICSI twin mothers rated their infant's general health poorer than IVF/ICSI singleton mothers did. All discrepancies between IVF/ICSI twins and singletons disappeared after stratification for birthweight except for NICU admissions and speech development. Multiple logistic regression analyses showed that both IVF/ICSI and non-IVF/ICSI twin parents experienced more marital stress [odds ratio (OR) 2.9, 95% CI 2.2-3.8] and that twins had more impact on the mother's life (OR 1.7, 95% CI 1.2-2.4) compared with singletons. Nevertheless, the only predictor of low divorce/separation risk was IVF/ICSI treatment. CONCLUSION: Our study indicates that physical health of IVF/ICSI twins is comparable with that of non-IVF/ICSI twins. However, physical health of IVF/ICSI twins is poorer and the implications for the families stronger compared with IVF/ICSI singletons.

Adult↗
PubMed2003

Health-related quality of life in relation to gender and age in couples planning IVF treatment.

BACKGROUND: Specific subgroups of people planning IVF might be at risk of having more psychological or health-related problems. Identification of subgroups at risk may better enable allocation of appropriate counselling. METHODS: A group of 425 men and 447 women planning to undergo IVF treatment filled out a questionnaire. Four domains of health-related quality of life were measured, namely perceived emotional, physical, cognitive and social functioning. RESULTS: Young men and women (aged 21-30 years) planning IVF had more short-term social and emotional problems than people of the same age group in the general population. No substantial differences were found in cognitive and physical functioning for all age groups of men nor women planning IVF compared with the general population. A high level of irrational parenthood cognitions substantially accounted for a less optimal score on all the different domains of quality of life. These cognitions ('needing a child in order to live a happy life') were especially prevalent among younger women. CONCLUSIONS: Patients with high levels of irrational parenthood cognitions are at risk of a less optimal quality of life. A short cognitive counselling therapy is advised for patients with high levels of these cognitions.

Adult↗
PubMed2004

ICSI versus conventional techniques for oocyte insemination during IVF in patients with non-male factor subfertility: a Cochrane review.

UNLABELLED: This paper is based on a Cochrane review of the same title by the same authors published in The Cochrane Library, issue 3, 2003 (see www.CochraneLibrary.net for information) with permission from the Cochrane Collaboration-John Wiley and Sons. Cochrane reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and The Cochrane Library should be consulted for the most recent version of the review. BACKGROUND: The objective of this review was to investigate whether ICSI improves live-birth rate in comparison with IVF in couples with non-male factor subfertility. METHODS: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched 30 May 2002), the Cochrane Controlled Trials Register (Cochrane Library Issue 2, 2002), PubMed (January 1992 to September 2003) and reference lists of articles. Trials were included if they compared the effects of ICSI and IVF on live births, pregnancy and fertilization outcomes. Only randomized studies were included in this review. Two reviewers extracted data independently. RESULTS: There were no randomized data comparing live-birth rates. The single identified study did not find a difference in pregnancy rates (OR 1.4, 95% CI 0.95-2.2). There were no randomized data on miscarriage rates, or on other adverse events such as congenital malformations that may be of concern (415 couples randomized). Two studies used alternation to assign their couples and did have live birth as an outcome. These studies showed a significantly higher fertilization rate in the IVF group, but no difference in pregnancy, miscarriage or live-birth rate. CONCLUSIONS: Whether ICSI should be preferred to IVF for cases of non-male factor subfertility remains an open question. Further research should focus on live-birth rates and adverse events.

Abortion, Spontaneous↗
PubMed2004

Neonatal outcome in a Danish national cohort of 3438 IVF/ICSI and 10,362 non-IVF/ICSI twins born between 1995 and 2000.

BACKGROUND: In Denmark, one-third of twin pregnancies are the result of IVF/ICSI treatment. Limited data on neonatal outcome in IVF/ICSI twins are available in the literature. METHODS: A register study was conducted on neonatal morbidity and mortality in a complete national twin cohort including all 3438 (3393 live-born) IVF/ICSI and 10,362 (10,239 live-born) non-IVF/ICSI twins born between 1995 and 2000. Twins were identified in the National Medical Birth Registry and dichotomized into IVF/ICSI and non-IVF/ICSI by cross-reference with the Danish IVF Registry. Data on neonatal morbidity and mortality were retrieved from the Danish Patient Registry and the Danish Registry of Causes of Deaths. In order to exclude monozygotic twins, sub-analyses on unlike-sex twins were conducted. RESULTS: A birth weight discordance of >20% was observed in 20.6% of IVF/ICSI versus 15.7% of control twin pairs (P < 0.001). The risk of discordant birth weight >20% was OR 1.29 (95% CI 1.04-1.58) in unlike-sex IVF/ICSI twins versus control twins. The risk of delivery at <37 completed weeks and birth weight <2500 g was similar in the two cohorts; however, in unlike-sex IVF/ICSI versus control twins the risk of delivery at <37 weeks and birth weight <2500 g was OR 1.22 (95% CI 1.09-1.38) and OR 1.25 (1.11-1.40) respectively. After stratification for maternal age and parity, these risks disappeared. IVF/ICSI twins carried a higher risk of admittance to a neonatal intensive care unit (NICU) than control twins (OR 1.18, 95% CI 1.09-1.27), and this was even more pronounced in unlike-sex twins [OR 1.34 (95% CI 1.19-1.51)]. No differences were observed in malformation or mortality rates between the two cohorts. CONCLUSIONS: Despite higher birth weight discordance and more NICU admissions among IVF/ICSI twins, neonatal outcome in IVF/ICSI twins seems to be comparable with that of non-IVF/ICSI twins, when only dizygotic twins were considered in the comparisons.

Birth Weight↗
PubMed2004

High endometrial aromatase P450 mRNA expression is associated with poor IVF outcome.

BACKGROUND: The success of IVF treatment is dependent upon embryo quality and coordinated growth and differentiation of the endometrium. Aromatase P450 expression in the human endometrium is thought to be restricted to women with proliferative reproductive tract disorders such as endometriosis, leiomyomas and adenomyosis. METHODS: To determine whether endometrial aromatase P450 mRNA expression is prognostic of IVF outcome, we quantified transcript levels in biopsy specimens from a cohort of subfertile patients awaiting IVF treatment using real-time quantitative PCR. RESULTS: Aromatase P450 transcripts were detected in all endometria examined, although the levels varied considerably between samples, ranging from 0.22 to 486.6 arbitrary units (a.u.). The clinical pregnancy rate in women with high endometrial aromatase P450 mRNA levels (> or = 8.3 a.u.; n = 21) was 9.5% compared with 30.1% in those patients with low expression levels (<8.3 a.u.; n = 101) (P < 0.05). The cycle day of the endometrial biopsy, cause of infertility, age, parity, number of oocytes collected and number of embryos transferred did not differ between patients with high versus low endometrial aromatase P450 mRNA levels (P > 0.1). CONCLUSIONS: Our results indicate that endometrial P450 mRNA levels can identify women at increased risk of IVF treatment failure.

Aromatase↗
PubMed2004

Maternal serum levels of interferon-gamma and interleukin-2 soluble receptor-alpha predict the outcome of early IVF pregnancies.

BACKGROUND: Elevated maternal serum levels of interleukin-2 soluble receptor-alpha (IL-2 sRalpha), tumour necrosis factor-alpha (TNF-alpha) and interferon-gamma (IFN-gamma) have been associated with pregnancy loss. The aim of our study was to evaluate the predictive value of these cytokines in the outcome of early IVF pregnancies. METHODS: One hundred and fifty-nine consecutive IVF patients who were subsequently diagnosed to have a biochemical pregnancy (n = 23), a first-trimester miscarriage (n = 19) or a normal term delivery (n = 117) were included in this study. Serum was collected from the initial pregnancy test, 11 days after a day 3 embryo transfer, and all samples were analysed for IL-2 sRalpha, TNF-alpha and IFN-gamma by commercially available enzyme-linked immunosorbent assay (ELISA) kits. RESULTS: IL-2 sRalpha levels were significantly higher in patients with an early pregnancy loss compared with patients with a normal term delivery (849.5 +/- 69.6 versus 693.5 +/- 31.2 pg/ml, P = 0.02), and a cut-off point of IL-2 sRalpha >1000 pg/ml predicted a poor pregnancy outcome (44.4 versus 22.7% pregnancy loss, IL-2 sRalpha >or=1000 versus IL-2 sRalpha <1000 pg/ml; P = 0.02). IFN-gamma-positive patients had twice the risk for poor IVF pregnancy outcome compared with IFN-gamma-negative subjects (40.8 versus 20.0%, respectively; P < 0.02), including a significantly lower implantation rate (37.6 +/- 0.05 versus 50.0 +/- 0.03%, respectively; P = 0.02). There was no difference in pregnancy outcome based upon serum levels, or the ability to detect the presence of TNF-alpha. No differences in levels of these cytokines were found based on the aetiology of the patients' infertility. CONCLUSIONS: Elevated maternal serum levels of IL-2 sRalpha and IFN-gamma as early as 11 days after embryo transfer are associated with poor IVF pregnancy outcome.

Adult↗
PubMed2004

Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers.

BACKGROUND: The difficulty of embryo transfer has been reported to affect success rates in some centres, but not in others. Cervical dilatation has been proposed as a means to overcome difficult embryo transfer, but consistent criteria for patient selection are lacking. In a prospective randomized study, we examined the influence of cervical dilatation 1-3 months before embryo transfer on the outcome of IVF in cases having difficult embryo transfer in two previously failed IVF cycles. METHODS: Two alternative methods of embryo transfer preparation were evaluated in 283 randomly assigned women having difficult embryo transfers in two previously failed IVF attempts. Randomization was made using a computer-generated random number table. Cervical dilatation before starting any IVF treatment was used in 145 cases, and no dilatation was performed in 138 cases. RESULTS: The cervical dilatation group yielded a significantly higher pregnancy rate than the non-dilated group (40% versus 24%; P < 0.01). Likewise, the implantation rate (24.1% versus 14.9%; P < 0.01) and the live birth rate (34.48% versus 19.56%; P < 0.01) were significantly higher in the dilatation group than in the non-dilated group. CONCLUSIONS: In patients with prior difficult embryo transfer, cervical dilatation 1-3 months before embryo transfer lead to an improved pregnancy rate.

Adult↗
PubMed2004

Expected poor responders on the basis of an antral follicle count do not benefit from a higher starting dose of gonadotrophins in IVF treatment: a randomized controlled trial.

BACKGROUND: The aim of this study was to evaluate the effect of doubling the starting dose of gonadotrophins on the ovarian response in IVF patients with a low antral follicle count (AFC). METHODS: Fifty-two patients with an AFC of <5 follicles of 2-5 mm diameter before starting their first IVF cycle participated in this randomized controlled trial. They were randomized by opening a sealed envelope, receiving either 150 IU (group I, n = 26) or 300 IU (group II, n = 26) of rFSH as a starting dose. The main outcome measures of the study were number of oocytes, poor response (<4 oocytes at retrieval or cancellation due to insufficient follicle growth) and ongoing pregnancy (12 weeks of gestation). RESULTS: The groups were comparable regarding patient characteristics and outcome of the IVF treatment. The median number of oocytes collected was 3 for both groups (P = 0.79). The difference in the mean number of oocytes was 0.3 oocytes in favour of group I (P=0.69). Sixty-five per cent of the patients in group I experienced a poor response and 62% in group II. The ongoing pregnancy rate was 8% in group I and 4% in group II (P = 0.55). CONCLUSIONS: Expected poor response patients, defined as patients with an AFC <5, are likely not to benefit from a higher starting dose of gonadotrophins in IVF.

Adult↗
PubMed2004

Minimal stimulation IVF with late follicular phase administration of the GnRH antagonist cetrorelix and concomitant substitution with recombinant FSH: a pilot study.

BACKGROUND: The use of the natural cycle for IVF offers the advantage of a patient-friendly and low-risk protocol. Its effectiveness is limited, but may be improved by using a GnRH antagonist to prevent untimely LH surges. METHODS: In this pilot study, minimal stimulation IVF with late follicular phase administration of the GnRH antagonist cetrorelix and simultaneous substitution with recombinant FSH was applied for a maximum of three cycles per patient. Main outcome measures were pregnancy rates per started cycle and cumulative pregnancy rates after three cycles. RESULTS: A total of 50 patients completed 119 cycles (2.4 per patient). Fifty-two embryo transfers resulted in 17 ongoing pregnancies [14.3% per started cycle; 32.7% per embryo transfer; 95% confidence interval (CI) 7.9-20.7% and 19.7-45.7%, respectively]. One dizygotic twin pregnancy occurred after transfer of two embryos, the other pregnancies were singletons. The cumulative ongoing pregnancy rate after three cycles was 34% (95% CI 20.6-47.4%). Live birth rate was 32% per patient (95% CI 18.8-45.2%). CONCLUSIONS: Pregnancy rates after IVF with minimal, late follicular phase stimulation are encouraging. Considering the low-risk and patient-friendly nature of this protocol, it may be a feasible alternative to IVF with ovarian hyperstimulation.

Adult↗
PubMed2005

A qualitative study of women's decision-making at the end of IVF treatment.

BACKGROUND: The decision not to pursue further in vitro fertilization (IVF) after one or more unsuccessful attempts is an important and often difficult one for couples. Relatively little is known about the woman's perception of this decision-making process. The aim of this study was to examine patients' perspectives of decision-making, including circumstances influencing it and satisfaction with the decision-making process. METHODS: Semi-structured interviews were conducted with a purposive sample of 25 women who had decided to end treatment after unsuccessful IVF treatment. Interviews were tape-recorded and transcribed by means of thematic analysis using the open coding technique. RESULTS: Women experienced difficulty in accepting that their infertility would remain unresolved. Many felt that they had started with unrealistic expectations of treatment success and felt vulnerable to the pressures of both the media and society. Although the decision to end treatment was difficult, it offered many women a way out of the emotional distress caused by IVF; however, the process of decision-making created a sense of 'confrontation' for the women in which they had to address issues they had previously avoided. Adoptive parents perceived less societal pressure than those who remained childless. CONCLUSIONS: Efforts to improve the psychological preparation of couples who decide to end IVF treatment should be directed towards examination of the existing system of consultation, which has certain limitations in terms of the quality of communication and the provision of post-treatment support. Further efforts to develop strategies, which facilitate the decision-making process, should be considered.

Adult↗
PubMed2005

Predictors of ongoing implantation in IVF in a good prognosis group of patients.

BACKGROUND: The aim of this study was to investigate whether, in a large randomized trial, it is possible to identify specific maternal and/or embryo variables that could independently correlate with ongoing implantation in IVF/ICSI. METHODS: In a Scandinavian study, 661 women were randomized to elective single embryo transfer or double embryo transfer. Women aged <36 years undergoing their first or second IVF cycle and with at least two good quality embryos were eligible. Only one cycle per subject was included. In the present study, cycles with 0 or 100% ongoing implantation (n = 520) were analysed regarding maternal and embryo variables. RESULTS: In this selected study group, the ongoing implantation rate was 195/734 (26.6%). In the univariate analysis, first IVF cycle, conventional IVF as fertilization method and 4-cell embryos showed a statistically higher ongoing implantation rate than did second IVF cycle, ICSI and non-4-cell embryos. In the multivariate analysis the same variables correlated independently to ongoing implantation. In addition, ovarian sensitivity correlated independently to ongoing implantation. CONCLUSION: This information should be used when selecting the number of embryos for transfer with the overall aim to reduce the rate of multiple births while maintaining a satisfactory birth rate.

Adult↗
PubMed2005

Sidestream smoking is equally as damaging as mainstream smoking on IVF outcomes.

BACKGROUND: Cigarette smoking (CS) is a widely recognized health hazard, yet it remains prevalent in society and the effects of environmental tobacco smoke exposure on fertility are unknown. Our objective was to measure the effects of CS on the fertility of mainstream (MS) or sidestream (SS) smoke-exposed women compared to their non-smoking (NS) counterparts. METHODS: This retrospective study investigated 225 female patients undergoing IVF (n = 97) or ICSI (n = 128). Patients were grouped based on their smoking status for comparison. This included: 39 MS (18 IVF and 21 ICSI); 40 SS (16 IVF and 24 ICSI); and 146 NS (63 IVF and 83 ICSI) women. Fertility treatment outcomes including embryo quality, implantation and pregnancy rate were measured. RESULTS: No difference in embryo quality between the three groups was observed. However, there was a significant difference in implantation rate (MS = 12.0%, SS = 12.6%, and NS = 25.0%) and pregnancy rate (MS = 19.4%, SS = 20.0%, and NS = 48.3%) per embryo transfer. CONCLUSIONS: Despite similar embryo quality there was a striking difference in implantation and pregnancy rates of MS and SS smokers when compared with NS. Our data demonstrate that the effects of SS smoking are equally as damaging as MS smoke on fertility.

Embryo Implantation↗
PubMed2005

Comparison of different treatment strategies in IVF with cumulative live birth over a given period of time as the primary end-point: methodological considerations on a randomized controlled non-inferiority trial.

BACKGROUND: We discuss methodological considerations related to a study in IVF, which compares the effectiveness, health economics and patient discomfort of two treatment strategies that differ in both ovarian stimulation and embryo transfer policies. METHODS: This was a randomized controlled clinical trial in two large Dutch IVF centres. The tested treatment strategies are: mild ovarian stimulation [including gonadotrophin-releasing hormone (GnRH) antagonist co-treatment] together with the transfer of one embryo, versus conventional stimulation (with GnRH agonist long protocol co-treatment) and the transfer of two embryos. Outcome measures are: (i) pregnancies resulting in term live birth; (ii) total costs per term live birth; and (iii) patient stress/discomfort per started IVF treatment, over a 12 month period. Power considerations for this study were an overall cumulative live birth rate of 45% for the conventional treatment strategy, with non-inferiority of the mild treatment strategy defined as a live birth rate no more than 12.5% lower compared with the conventional study arm. For a power of 80% and alpha of 0.05, 400 subjects are required. RESULTS: As planned, from February 2002 until February 2004, 410 patients were enrolled. CONCLUSIONS: This effectiveness study applies an integrated medical, health economics and psychological approach with term live birth over a given period of time after starting IVF as the end-point. Complete and timely patient enrolment vindicates many of the design decisions.

Birth Rate↗