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Clomifene citrate and intrauterine insemination as first-line treatments for unexplained infertility: are they cost-effective?

Posted: January 22, 2011 at 6:12 pm

BACKGROUND

First-line treatments for unexplained infertility traditionally include clomifene citrate (CC) or unstimulated intrauterine insemination (IUI). A recently published randomized controlled trial considered the effectiveness of CC and IUI in patients with unexplained infertility and found that neither treatment offered a superior live birth rate when compared with expectant management (EM). This paper reports the economic evaluation conducted alongside this trial in order to assess whether health care providers are gaining value for money in this clinical area.

METHODS

Five hundred and eighty women across five Scottish hospitals were randomized to either EM, CC or IUI for 6 months. The primary outcome measure was live births. Resource-use data were collected during the trial and costs were calculated from a UK National Health Service (NHS) perspective. Incremental cost–effectiveness ratios were calculated, expressed as cost per live birth, in order to compare the cost–effectiveness of CC and IUI with that of EM to treat unexplained infertility.

RESULTS

Live birth rates in the three randomized groups were: EM = 32/193 (17%), CC = 26/194 (13%) and IUI = 43/193 (22%). The mean (standard deviation) costs per treatment cycle were £0 for EM, £83 (£17) for CC and £98 (£31) for IUI. The mean treatment costs per patient for EM, CC and IUI were £12 (£117), £350 (£220) and £331 (£222), respectively. The cost per live birth for EM, CC and IUI was £72 (95% confidence interval £0–£206), £2611 (£1870–£4166) and £1487 (£1116–£2155), respectively. The incremental cost–effectiveness ratio for IUI versus EM was £5604 (–£12204 to £2227), with CC dominated by IUI.

CONCLUSIONS

Despite being more expensive, existing treatments such as empirical CC and unstimulated IUI do not offer superior live birth rates compared with EM of unexplained infertility. They are unlikely to be a cost-effective use of limited NHS resources. The study's main limitation is that it did not consider the psychological effects on couples.

ISRCT Number: 71762042.

Recommendation and review posted by G. Smith

Italian Constitutional Court modifications of a restrictive assisted reproduction technology law significantly improve pregnancy rate

Posted: January 22, 2011 at 6:12 pm

BACKGROUND

In May 2009, the Italian Constitutional Court banned most of the limitations of a restrictive law regulating assisted reproduction technology on the grounds that it limited a couple's right to have access to the best possible medical treatment and reduce any possible higher risk of complications. The aim of the study was to compare our results in fresh cycles before and after this change.

MATERIALS AND METHODS

We analysed retrospectively 3274 IVF cycles: 2248 before and 1026 after the law was modified.

RESULTS

There was no significant difference between the two groups in terms of age, basal FSH levels, years of infertility, the number of previous cycles or the number of oocytes retrieved but the number of oocytes used (2.7 ± 0.6 versus 4.6 ± 1.8; P = <0.001), the number of embryos obtained (2.0 ± 0.9 versus 3.3 ± 1.8; P = <0.001) and transferred (2.2 ± 0.7 versus 2.3 ± 0.7; P = <0.001) were all higher after the removal of the previous restrictions, as was the pregnancy rate per started cycle (23.49% versus 20.42%; P = 0.047). Before modification of the law, the pregnancies were single in 74.11% of the cases (versus 71.43% afterwards), twins in 23.44% (versus 26.89%; P = 0.318) and triplets in 2.46% (versus 1.68%; P = 0.594).

CONCLUSIONS

Our preliminary results after the removal of the previous legal restrictions show a higher pregnancy rate per started cycle (3.7% represents a 15% difference) and a positive (albeit non-significant) trend towards a reduction in the number of multiple pregnancies.

Recommendation and review posted by G. Smith

Anonymity and secrecy options of recipient couples and donors, and ethnic origin influence in three types of oocyte donation

Posted: January 22, 2011 at 6:12 pm

BACKGROUND

This study compares recipient couples' and donors' motivations towards the type of donation and attitudes concerning secrecy or disclosure of the mode of conception in three oocyte donation groups: couples and their donor for a known donation, couples and their donor for a permuted anonymous donation (known-anonymous) and couples without a donor, on a waiting list for a donation (anonymous).

METHODS

Data collected by two psychologists through semi-structured interviews of 135 recipient couples and 90 donors before oocyte donation were analysed retrospectively.

RESULTS

In known donation (42 couples), donors were preferentially family members with a blood tie (54.7%). Choosing their donor seemed mainly for the couple's reassurance rather than to access the child's origins as 50% wanted secrecy. On the other hand, in known-anonymous donation (48 couples), donors were more frequently chosen among friends (41.6%; P = 0.038). These couples were either open to disclosure (45.8%; P= 0.002) or remained hesitant (39.6%). In anonymous donation (45 couples), 49% chose not to seek a donor mostly in order to maintain secrecy towards the child (77.3%). Among the 51% who sought but could not find a donor, only 30.4% wanted secrecy. Recipients from North Africa and from Europe preferred anonymous or known-anonymous donation (83.3 and 75.6%), whereas sub-Saharan Africans opted more often for known donation (63%; P <0.001). Among Europeans (90 couples), 50% were in favour of disclosure compared with only 8.9% of recipients from North or sub-Saharan Africa (45 couples; P< 0.001).

CONCLUSIONS

A diversity of attitudes and cultural differences exist among recipient couples and donors regarding oocyte donation; this pleads for maintaining access to different types of oocyte donation as well as for psychological counselling prior to treatment.

Recommendation and review posted by G. Smith

Reproductive outcome after early-onset pre-eclampsia

Posted: January 22, 2011 at 6:12 pm

BACKGROUND

Early-onset pre-eclampsia is an important cause of maternal and neonatal morbidity and mortality and is believed to have a significant impact on future maternal physical and psychological health. However, structured follow-up data of women with a history of early-onset pre-eclampsia are lacking. This study aims to present comprehensive data of a large cohort of women with a history of early-onset pre-eclampsia with respect to future reproductive health, family planning and subsequent pregnancy rates.

METHODS

A tertiary referral cohort of 304 women entered the follow-up study at 6–12 months after their first delivery. Detailed data on maternal and neonatal outcomes, family planning and subsequent pregnancies were recorded. In addition, data on perspectives, major concerns and decision-making of women who had not achieved a second pregnancy were collected by questionnaire and structured interviews. Data were compared with a population of 268 low-risk primiparous women with an uncomplicated delivery.

RESULTS

At a mean of 5.5 years after first delivery, 65.8% of women with a history of early-onset pre-eclampsia had achieved a second pregnancy compared with 77.6% of healthy controls. At follow-up, 19.1% of women with a history of early-onset pre-eclampsia had an active wish to become pregnant, whereas 15.1% of women did not wish to achieve a future pregnancy. In the latter group, decision-making was most commonly influenced by fear of recurrent disease (33%) and fear of delivering another premature child (33%) among others reasons, e.g. post-partum counseling and concerns of the partner.

CONCLUSIONS

The majority of women with a history of early-onset pre-eclampsia achieve or wish to achieve a second pregnancy within a few years of their delivery. Nonetheless, first pregnancy early-onset pre-eclampsia appears to have a significant impact on future reproductive health and decision-making, emphasizing the importance of careful post-partum counseling.

Recommendation and review posted by G. Smith

Characterization of invasive trophoblasts generated from human embryonic stem cells

Posted: January 22, 2011 at 6:12 pm

BACKGROUND

Abnormal human embryo implantation leads to poor foetal development and miscarriage, or pre-eclampsia. Ethical and practical considerations concerning implantation limit its investigation, and it is often difficult to extrapolate findings in laboratory animals when implantation processes show diverse species differences. Therefore, it is important to develop new in vitro models to study the earliest events of human implantation. The aim of this study was to derive trophoblast cell lines from human embryonic stem cells (hESCs) by a robust protocol and co-culture of these cells with an established endometrial cell culture system to validate a model of trophoblast invasion at implantation.

METHODS

Derivation of trophoblast cell lines from hESC lines was established by spontaneous and induced differentiation of embryoid bodies and by initial measurement of hCGβ secretion by enzyme-linked immunosorbent assay and their phenotype investigated using gene- and protein-expression markers. Vesicles formed from an aggregating trophoblast were co-cultured with decidualized human endometrial stromal cells in hypoxic (2% oxygen) and normoxic (20% oxygen) environments.

RESULTS

Derived villous cytotrophoblast cell (CTB) lines further differentiated to invasive, extra-villous CTBs. Eventually, cells lost their proliferative capacity, with some lines acquiring karyotypic changes, such as a gain in the X chromosome. Cell-invasion assays confirmed that the extra-villous CTBs were invasive and erosion of the endometrial stromal layer occurred, particularly under hypoxic conditions in vitro.

CONCLUSIONS

Trophoblast cell lines derived from hESCs differentiate and adapt in vitro and can be used as a model to study the mechanisms of early trophoblast invasion.

Recommendation and review posted by G. Smith

Thrombin-induced chemokine production in endometrial stromal cells

Posted: January 22, 2011 at 6:12 pm

BACKGROUND

In order to investigate the regulation of chemokines [interleukin-8 (IL-8), growth-regulated oncogene (GRO), monocyte chemoattractant protein-1 (MCP-1)) induced by thrombin in endometrial stromal cells (ESCs), the effects of thrombin, a protease activated receptor (PAR)-1 antagonist (PPACK), mitogen-activated protein kinase kinase inhibitor (U0126), phospholipase C inhibitor (U-73122), an antagonist of the intracellular InsP3 receptor (2-aminoethoxy-diphenylborate (2-APB)] and a protein kinase C inhibitor (GF-109203X) on the production of chemokines by ESCs were evaluated.

METHODS

ESCs from eight endometrial specimens in the secretory phase were cultured and incubated for 24h with thrombin and PPACK, U0126, U-73122, 2-APB or GF-109203X. The levels of IL-8, GRO and MCP-1 in the culture medium were measured by means of ELISA. The activation of MAP kinase was detected by western blot analysis using anti-phosphorylated MAP kinase (ERK1/2) antibody.

RESULTS

Following stimulation by thrombin, the production of IL-8, GRO and MCP-1 increased significantly in a dose-dependent manner. PPACK, U0126, U-73122, 2-APB or GF-109203X suppressed the increases in production of IL-8, GRO and MCP-1 induced by thrombin (P < 0.001, P <0.001 and P <0.001, respectively). MAP kinase activities were induced by treatment with thrombin, and were suppressed by PPACK, U0126, U-73122, 2-APB or GF-109203X.

CONCLUSIONS

Our results suggest that thrombin stimulates the production of IL-8, GRO and MCP-1 via PAR-1 by a mechanism involving the MAP kinase system. The increases in IL-8, GRO and MCP-1 may contribute to the maintenance of implantation involving leukocyte chemotaxis.

Recommendation and review posted by G. Smith


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