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PubMed2005

Safety of drugs used in assisted reproduction techniques.

Infertility may affect one in six couples; however, the development of the assisted reproduction technique (ART) created the opportunity for a large proportion of the infertile population to bear children. Pharmacological agents are routinely used in ART, and new ones are introduced regularly, with the aim of retrieving multiple oocytes to increase the prospect of pregnancy. The combinations of drugs that are used have specific adverse effects, but it is mostly the combined action of more than one agent that causes the greatest concern. The matter is complicated by the suspicion that some techniques in ART, for example intracytoplasmic sperm injection for severe male infertility problems (including azoospermia), may also contribute to the increase in adverse effects, especially congenital malformation. Gonadotropin releasing hormone (GnRH) agonists are widely used in controlled ovarian hyperstimulation. It may give rise to a short period of estradiol withdrawal symptoms and it may also lead to luteal phase deficiency. Similarly GnRHa antagonists, which have been recently introduced to control ovarian hyperstimulation, can lead to luteal phase deficiency and may cause some local injection site reactions. The more pure form of gonadotropin leads to less local injection site reactions and their main adverse effects are associated with the consequences of multiple ovulations. It has been proposed that gonadotropins may be a factor in the increasing risk of ovarian cancer and possibly breast cancer, but this has not been substantiated. Prion infection is another potential hazard, although no cases have been reported. Ovarian hyperstimulation syndrome is a well recognised complication of controlled ovarian hyperstimulation in ART. It is usually a result of recruitment of a large number of ovarian follicles. Efforts to minimise the incidence of this syndrome and its severity are now well developed. Congenital malformations are another possible adverse effect of fertility drugs, but it is more probable that the increase in congenital abnormality that is reported in ART is because of the population studied, i.e. patients already at high risk of congenital malformation, rather than the fertility drugs used or the technique employed. High order multiple pregnancy and its sequela is a well established complication of controlled ovarian hyperstimulation. This could be a result of multiple ovulations or more than one embryo replacement. Reducing the number of embryos transferred can reduce this more serious adverse effect for expectant mothers and for children conceived from ART.

Gonadotropins↗
PubMedDate not supplied

[Genetic engineering and assisted reproduction techniques in man: a framework for sociologic analysis].

The possibilities opened up by genetic engineering and assisted reproduction techniques require reflection by sociologists and extensive public debate. In view of their potential as factors of social change, evaluation and control are warranted. They can be viable only if transparent and through public co-responsibility, for which an exchange of views is needed between all those who play a part in the development of said techniques. This dialogue must be wholly interdisciplinary and democratic.

Forecasting↗
PubMed1995

The efficacy and cost effectiveness of embryo cryopreservation compared with other assisted reproductive techniques.

OBJECTIVE: To evaluate the efficacy and cost effectiveness of embryo cryopreservation compared with other assisted reproductive techniques (ARTs). DESIGN: Retrospective review of medical records and health care costs. SETTING: Tertiary care academic medical school ART program. PATIENTS: For determination of the efficacy of cryopreserved ET, we analyzed 610 patients undergoing the first 1,000 oocyte retrievals in our program. For determination of cost effectiveness, we analyzed the costs associated with 334 initiated ART cycles in 1992. MAIN OUTCOME MEASURES: The ongoing pregnancy rate (PR) per initiated cycle and per oocyte retrieval. The medical costs associated with each procedure. RESULTS: The transfer of cryopreserved embryos increased the ongoing PR per oocyte retrieval by 6.6%. Transfer of cryopreserved embryos was cost effective compared with other ARTs. The cost per delivery for cryopreserved ETs was between 25% and 45% that of a fresh cycle. CONCLUSIONS: Including embryo cryopreservation in an ART program can improve PRs and lower the ultimate cost per delivery.

Cost-Benefit Analysis↗
PubMed2003

Outcome of twin pregnancies after assisted reproductive techniques--a comparative study.

OBJECTIVE: To compare obstetrical and perinatal outcome of twin pregnancies after assisted reproductive techniques (ART) with that of twins conceived spontaneously. STUDY DESIGN: Hospital based retrospective study. RESULTS: There were 132 twin deliveries of which 36 were conceived after ART. Patients of the ART group were mostly nulliparous and slightly older. There was no statistically significant difference in the frequency of preterm delivery or mean gestational age at delivery. Elective Caesarean delivery was more frequent in twin pregnancies conceived after ART, and there were no other differences in maternal complications. There was also no difference in the mean birth weight or frequency of neonatal complication between the two groups. CONCLUSION: In this comparative study, the obstetric and neonatal outcomes between spontaneous twins and those conceived after ART are similar except for higher operative deliveries in the latter group of twins.

Adult↗
PubMed2006

Oxidative stress in an assisted reproductive techniques setting.

OBJECTIVE: The manipulation of gametes and embryos in an in vitro environment when performing assisted reproductive techniques (ART) carries the risk of exposure of these cells to supraphysiological levels of reactive oxygen species (ROS). The main objective of this review is to provide ART personnel with all the necessary information regarding the development of oxidative stress in an ART setting, as well as the sources of ROS and the mechanisms of oxidative stress-induced damage during ART procedures. The impact of oxidative stress on ART outcome and the different strategies designed to prevent it are also discussed. DESIGN: Review of international scientific literature. A question-and-answer format was adopted in an attempt to convey comprehensive information in a simple yet focused manner. RESULT(S): The pO(2) to which gametes and the embryo are normally exposed in vivo is significantly lower than in vitro. This results in increased production of ROS. Increase in levels of ROS without a concomitant rise in antioxidant defenses leads to oxidative stress. Lipid, protein, and DNA damage have all been associated with oxidative stress. This may ultimately result in suboptimal ART success rates. CONCLUSION(S): Many modifiable conditions exist in an ART setting that may aid in reducing the toxic effects of ROS.

Embryo, Mammalian↗
PubMed2001

Investigation into effectiveness of counseling on assisted reproductive techniques in Turkey.

This experimental study was conducted to determine the specific problems experienced by couples participating in assisted reproductive techniques (ART) and to assess couples' counseling needs. It was also intended to determine the effects of the counseling service model, developed and implemented by the researcher, on the success rate of ART, and to assess the couples' anxiety, depression and life satisfaction levels. Thirty couples for the experimental group and 30 couples for the control group were included in the study. The couples in the control group experienced the routine procedures that the treatment currently includes. Couples in the experimental group took part in the counseling service model, and were informed and supported throughout the steps of the ART A guide developed for the couples and education material developed for the counseling service model were used during the study. Three psychological tests were given to the couples before (pretest) and after (post-test) each procedure. These tests included anxiety, depression and life satisfaction inventories. The difference means test and Student's t test were used for statistical analysis. The results of the study showed that couples in the experimental group had lower anxiety and depression scores than the couples in the control group. Life satisfaction scores and pregnancy rates were higher for couples in the experimental group than for the couples in the control group. Statistical evaluation showed that the difference between the experimental group and the control group was significant (p < 0.05). This study demonstrates the importance of the counseling role of the nurse, and the development and application of counseling services in ART centers, in lowering the anxiety and depression levels of couples and ensuring success of the treatment.

Adaptation, Psychological↗
PubMed2005

Screening of mutations in the CFTR gene in 1195 couples entering assisted reproduction technique programs.

Genetic testing of the cystic fibrosis transmembrane conductance (CFTR) gene is currently performed in couples undergoing assisted reproduction techniques (ART), because of the high prevalence of healthy carriers in the population and the pathogenic relationship with congenital bilateral absence of vas deferens (CBAVD). However, discordant data have been reported concerning the usefulness of this genetic test in couples with no family history of cystic fibrosis (CF). In this study, we report the results of CFTR molecular screening in 1195 couples entering ART. Genetic testing was initially carried out in a single partner of each couple. CFTR mutations were detected in 55 subjects (4.6%), a percentage that overlaps with the one reported in the general population. However, significantly higher frequencies of were found in CBAVD individuals (37.5%) and in males with nonobstructive azoospermia (6.6%). The 5T allele was found in 78 patients (6.5%). This figure was again significantly different in males with nonobstructive-azoospermia (9.9%) and in those with CBAVD (100%). All together, 139 subjects (11.6%) had either a CFTR mutation or the 5T allele. Subsequent molecular analysis of their partners disclosed a CFTR mutation or 5T allele in nine cases (6.5%). However, none of these couples had CFTR alterations in both members, a CFTR mutation being invariably present in one partner and the 5T allele in the other. In order to improve genetic counselling of these couples, the TG-M470V-5T association was analyzed, and a statistically significant relationship between 12TG-V470 and CBAVD was detected.

Alleles↗
PubMed2003

Male age is not an independent factor to affect the outcome of assisted reproductive techniques.

Controversy exists whether advanced male age is associated with poor sperm quality and subsequent failure in the assisted reproductive techniques (ART). The purpose of this study was to evaluate the effect of male age on sperm quality and the outcome of ART as well as the association of male age with other relevant factors, particularly with the female age. A retrospective study was performed in order to evaluate the effect of male age on the sperm parameters in 880 routine seminal analyses. Additionally, sperm parameters were also compared among different age groups in 919 cases with male factor infertility who had been included in an ART programme. The laboratory and clinical results of ART (fertilization rate, number and quality of embryos transferred, as well as pregnancy rates) were compared according to different age groups. The results were also evaluated by one-way correlation and also step-wise logistic regression analysis to identify the interactions and correlations between different parameters. There were no statistically significant differences between male age groups in terms of sperm concentration, motility and morphology either in routine seminal analyses or in ART groups. In the ART group, a statistically significant linear correlation was present between male and female ages. Male age was increasing in parallel to female age. Female age was also correlated significantly with ART results. In one-way correlation analysis, male age was found to be correlated with the pregnancy rate, but not with fertilization rate and the quality of the transferred embryos. However, regression analysis revealed that correlation between male age and pregnancy results was simply dependent on the effect of the female age. Seminal parameters did not reveal a significant change with the increasing male age. The effect of male age on ART results in cases with male factor infertility is not a direct effect but a reflection of the negative impact of the parallel increase in the female age.

Adult↗
PubMedDate not supplied

[The Constitutional Court regarding Assisted Reproduction Techniques: a critical assessment].

Last June Spain's Constitutional Court ruled on the challenge lodged against Law 35/1988 on Assisted Reproduction Techniques (Ruling 116/1999). The ruling confirmed the provisions of the Law. However, in examining the Law in question the Court did not, in my opinion interpret correctly the Spanish Constitution. I argue that there are three main areas of disagreement: since the contents directly affect human dignity the Law should have taken the form of a higher (Organic) Law. Secondly, the Law's treatment of in vitro fertilised embryos in certain cases, falls short of the minimum required by the Constitution. Thirdly, paternity investigation is prevented contrary to the provisions of the Constitution and hence the constitutional notion of family is undermined.

Family↗
PubMed1993

In vitro fertilization and other assisted reproductive techniques.

Each year, thousands of pregnancies are achieved worldwide by in vitro fertilization (IVF) and its modifications, commonly grouped under the general term "assisted reproductive techniques" (ARTs). The IVF program at the University of Southern California (USC) was among the first to be established in the United States and had the distinction of achieving success, in 1981, with the first IVF infant to be born on the West Coast. This paper discusses patient selection, superovulation techniques, methods of follicle aspiration, sperm preparation, embryo transfer procedures and management of the luteal phase of ART cycles. The various ARTs are described, as are the expected success rates. Particular emphasis is placed on the techniques of oocyte donation and unstimulated IVF, both of which play prominent roles in the treatment of infertility in the USC program.

Fertilization in Vitro↗
PubMed2004

Gonadotropin-releasing hormone antagonists for assisted reproductive techniques: are there clinical differences between agents?

Gonadotropin-releasing hormone (GnRH) antagonists have been tested extensively in ovarian stimulation protocols for assisted reproductive techniques (ART). GnRH antagonists immediately and rapidly inhibit gonadotropin release by the anterior pituitary gland by competitive blockage of the GnRH receptor, preventing and interrupting luteinising hormone surges in controlled ovarian hyperstimulation for infertility treatment. A review of the available literature on GnRH antagonists for ART is presented, focusing on the pharmacological and clinical properties of the two compounds available on the market, cetrorelix and ganirelix. Both cetrorelix and ganirelix are well tolerated and effective drugs for controlled ovarian hyperstimulation and are of comparable value for infertility treatment. Cetrorelix is available as a 0.25mg preparation for daily injections and as a 3mg intermediate depot preparation. Ganirelix is available as a 0.25mg preparation for daily injections.Currently, two treatment protocols are used in clinical practice: the GnRH antagonist multiple-dose protocol and the GnRH antagonist single-dose protocol. Both protocols are effective and well tolerated. Cetrorelix and ganirelix have not yet been directly compared in a clinical trial; nor have the single-dose and the multiple-dose approaches been compared in a randomised, controlled trial. Data to compare these compounds in clinical terms can be extrapolated only from results of phase II dose-finding studies and phase III studies comparing GnRH agonist cycles with GnRH antagonists in single- and multiple-dose protocols. Therefore, all conclusions on clinical differences between cetrorelix and ganirelix should remain tentative, as they are based on a limited amount of available data.Randomised, controlled trials comparing cetrorelix and ganirelix are warranted to further evaluate benefits and drawbacks of individual GnRH antagonists. Furthermore, more data are needed to determine the efficacy and safety of cetrorelix and ganirelix in established treatment protocols in patients other than those included in clinical trials investigating new drugs, such as "poor responders", patients with polycystic ovaries, patients with a history of allergy or overweight patients.

Clinical Trials as Topic↗
PubMed2005

Redefining the relationship between sperm deoxyribonucleic acid fragmentation as measured by the sperm chromatin structure assay and outcomes of assisted reproductive techniques.

OBJECTIVE: To test the hypothesis that couples with sperm chromatin structure assay (SCSA) DNA fragmentation index (DFI) values >27% would not achieve pregnancy with assisted reproductive techniques (ART) and to investigate how DFI and high DNA stainability (HDS), as measured by the SCSA, affect fertilization, cleavage, implantation, and pregnancy rates in IVF cycles. DESIGN: Prospective clinical study. SETTING: Academic human reproduction laboratory. PATIENT(S): One hundred couples undergoing IVF with conventional insemination or intracytoplasmic sperm injection. INTERVENTION(S): Testing with SCSA was performed by SCSA Diagnostics (Brookings, South Dakota) on a semen aliquot taken from ejaculate used for ART. MAIN OUTCOME MEASURE(S): Relating total DFI and HDS to conventional semen parameters and cycle-specific outcomes after ART. RESULT(S): Nine of nineteen couples achieved clinical pregnancy when DFI was > or =27%, and 2 of 22 couples achieved clinical pregnancy when DFI was < or =9%. One of nine couples achieved clinical pregnancy with HDS >17%. The DFI was negatively correlated with sperm density (r = -0.23, P<.03) and motility (r = -0.55, P<.00), and HDS was negatively correlated with sperm density (r = -0.37, P<.00). CONCLUSION(S): Sperm chromatin structure assay failed to identify elevated DFI thresholds for negative pregnancy outcome after ART. Patients with low DFI (< or =9%) were least likely to become pregnant, which is also contradictory to SCSA marketing, which states that DFIs of < or =15% have excellent fertility potential. Patients with HDS > or =17% had low pregnancy rates, indicating decreased fertility potential, which deserves further investigation. Larger studies are necessary to confirm that low DFI is associated with decreased fertility and, if proved, might redefine the use of the SCSA in evaluating infertility.

Adult↗
PubMedDate not supplied

[Genetic reading of the decision of the Constitutional Court on the appeal on unconstitutionality against Law 35/1988 on Assisted Reproduction Techniques].

In this article we provide a "genetic reading" of the challenge on grounds of alleged inconstitutionality made against Spain's Law on Assisted Reproduction Techniques (Law 38/1988) and of the ruling handed down by the Constitutional Court on 17 June 1999. A critical appraisal is given of some genetic and biological concepts which, in the author's view, are used incorrectly in the legal texts presented. The article also shows that at the heart of the matter lies still the latent problem of the status in law of embryos. Lastly, brief reference is made to the issue of freedom of research.

Embryo, Mammalian↗
PubMedDate not supplied

Impact of urinary FSH price: a cost-effectiveness analysis of recombinant and urinary FSH in assisted reproduction techniques in the USA.

This study compares the cost-effectiveness of recombinant human FSH (r(h)FSH, Gonal-F) and urinary FSH (uFSH) in assisted reproduction techniques in the USA, using several hypothetical prices for uFSH. A specifically designed Markov model and Monte-Carlo simulation techniques were used to model the possible outcomes during three treatment cycles. Data included in the model were derived from randomized clinical trials and databases. An expert panel determined probability distributions for each decision point throughout each virtual treatment cycle. The assumed unit cost of r(h)FSH was $58.52 (based on the average retail cost) and three unit prices ($49, $45, $40) were used for uFSH. A total of 5000 simulations was performed on a virtual cohort of 100,000 patients. The mean number of assisted reproduction treatment cycles/success (ongoing pregnancy at 12 weeks) was 4.34 with r(h)FSH and 4.75 with uFSH. The total number of pregnancies achieved was 40,665 and 37,890, respectively. The mean cost per successful pregnancy with r(h)FSH was $40 688. For uFSH at unit costs of $40, $45 and $49, the mean costs per successful pregnancy were $43,500, $44,400 and $45,000, respectively (each P < 0.0001 versus r(h)FSH). Thus, despite its greater cost per unit dose, r(h)FSH is more cost-effective than uFSH over a wide range of uFSH prices, reflecting the greater clinical efficacy of r(h)FSH.

Cost-Benefit Analysis↗
PubMed1998

Lower risks of adverse outcome in twins conceived by artificial reproductive techniques compared with spontaneously conceived twins.

The outcomes of twins conceived by 136 women after medical assistance (MA) such as ovulation induction with or without assisted reproductive techniques, and twins conceived spontaneously (SP) by 72 women were compared. All 208 women were monitored from < 20 weeks gestation; they all delivered at > or = 24 weeks gestation. The chorionicity of the placenta was diagnosed antenatally and confirmed after delivery. There were 10 perinatal deaths; the physical and neurological status of the remaining 406 infants was assessed at 1 year of corrected age. There were no differences in gestational age at birth, the birth weights of the larger and smaller twins, the birth weight discordance, or the incidence of life-threatening major malformations between groups. Adverse infant outcomes, such as death, cerebral palsy and mental retardation occurred in nine (3.3%) of 272 MA twins compared with 12 (8.3%) of 144 SP twins (P < 0.05). The placenta was monochorionic in only three (2.2%) of 136 MA twin pregnancies compared with 41 (57%) of 72 SP twin pregnancies (P < 0.001). Of the 21 infants with adverse outcomes, nine had monochorionic placentas. Thus, the risk of an adverse outcome was 2.8-fold higher (95% confidence interval (CI) 1.2-6.4) in monochorionic twins than in dichorionic twins (10 versus 3.7%; P < 0.05). There was no difference in the incidence of adverse infant outcomes between SP (4.8%) and MA (3.4%) twins with dichorionic placentas. These findings suggest that ovulation induction in itself was not associated with an adverse outcome of twin pregnancies. The lower frequency of monochorionic placentas in MA twins may have been responsible for the lower risk of an adverse outcome in MA twins.

Birth Weight↗
PubMed1992

Effects of smoking on ovulation induction for assisted reproductive techniques.

OBJECTIVE: To determine the effects of smoking on ovulation induction for assisted reproductive techniques. DESIGN: Matched, retrospective, cohort study. SETTING: Outpatient University endocrine/infertility program. PATIENTS: Eighteen smokers and 36 nonsmokers: 2 nonsmokers matched to each smoker for age, weight, and history of ovarian surgery. MAIN OUTCOME MEASURES: During a stimulation cycle, the serum estradiol (E2) level, number of follicles, number of oocytes, number of embryos, and ampules of gonadotropins used were compared in the smoking versus the nonsmoking groups by Wilcoxon's signed rank test for paired data. Follicular fluid (FF), testosterone (T), androstenedione (A), E2, A:E2 ratios, and T:E2 ratios were measured and compared between groups by Mann-Whitney U-tests. RESULTS: Smokers had significantly lower serum E2 levels, fewer follicles, fewer oocytes retrieved, and fewer embryos per cycle than nonsmokers, despite equal amounts of gonadotropin administration. Follicular fluid obtained from mature follicles had a higher A:E2 ratio and a higher T:E2 ratio in smokers compared with nonsmokers. CONCLUSIONS: Smoking adversely affects ovulation induction parameters and alters the FF hormonal milieu.

Adult↗
PubMed2003

Cost-effectiveness of recombinant versus urinary follicle-stimulating hormone in assisted reproduction techniques in the Spanish public health care system.

PURPOSE: To evaluate the relative cost-effectiveness of recombinant and urinary follicle-stimulating hormone (FSH) in assisted reproduction techniques in the Spanish National Health Service. METHODS: Markov modelling was used to compare costs and outcomes of three complete treatment cycles using recombinant or urinary FSH for controlled ovarian stimulation. Cost and effectiveness estimates were obtained from the literature and from Spanish clinicians. A Monte Carlo technique was used to randomise the distribution of outcomes at each stage. The analysis was performed by passing a virtual population of 100,000 patients through the computer simulation in each of 5000 Monte Carlo simulations. RESULTS: The cost per pregnancy was Euro12,791+/-1202 ($11,346+/-1066) with recombinant and Euro13,007+/-1319 ($11,537+/-1170) with urinary FSH (p < 0.0001). The mean number of cycles per pregnancy was 4.69 and 5.21, respectively. CONCLUSIONS: Recombinant FSH is more cost-effective than urinary FSH in the Spanish public health care system.

Female↗
PubMed2002

Risk of cranial ultrasound abnormalities in very-low-birth-weight infants conceived with assisted reproductive techniques.

OBJECTIVE: To evaluate risks of cranial ultrasound abnormalities among very-low-birth-weight (VLBW) infants conceived with fertility therapy (ovulation induction only or with assisted reproductive techniques [ART]) and of multiple gestation pregnancies. STUDY DESIGN: The incidences of cranial ultrasound abnormalities in 1473 VLBW infants conceived with and without fertility therapy and born of multiple versus singleton pregnancies were compared, using logistic regression models. RESULTS: Infants conceived with ART were less likely to have intraventricular hemorrhage (IVH). Twins and triplets had risks of cranial ultrasound abnormalities similar to those of singletons. Twins and triplets conceived with ART were at lower risk of IVH. CONCLUSION: VLBW infants conceived with ART do not appear to be at increased risk of cranial ultrasound abnormalities. Likewise, twins and triplets were not at increased risk of these abnormalities.

Brain Damage, Chronic↗