Salpingotomy versus salpingectomy in women with tubal pregnancy (ESEP study): an open-label, multicentre, randomised controlled trial.

BACKGROUND: Tubal ectopic pregnancy can be surgically treated by salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with salpingectomy. METHODS: In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. FINDINGS: 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60·7% after salpingotomy and 56·2% after salpingectomy (fecundity rate ratio 1·06, 95% CI 0·81-1·38; log-rank p=0·678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the salpingectomy group (14 [7%] vs 1 [<1%]; RR 15·0, 2·0-113·4). Repeat ectopic pregnancy occurred in 18 women (8%) in the salpingotomy group and 12 (5%) women in the salpingectomy group (RR 1·6, 0·8-3·3). The number of ongoing pregnancies after ovulation induction, intrauterine insemination, or IVF did not differ significantly between the groups. 43 (20%) women in the salpingotomy group were converted to salpingectomy during the initial surgery because of persistent tubal bleeding. Our meta-analysis, which included our own results and those of one other study, substantiated the results of the trial. INTERPRETATION: In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with salpingectomy. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW), Region Västra Götaland Health & Medical Care Committee.

Quality of life after adopting compared with childbirth with or without assisted reproduction.

OBJECTIVE: This study compares quality of life among couples who had adopted a child 4-5.5 years previously with couples whose conception was spontaneous, as well as with couples who had successful or unsuccessful in vitro fertilization (IVF) treatment. DESIGN: Cross-sectional study. SETTING: Tertiary level university hospital. SAMPLE: From the following groups, 979 responses were obtained: adoption; successful IVF; unsuccessful IVF-living with children; unsuccessful IVF-living without children; and childbirth after spontaneous conception (controls). METHODS: Quality of life was studied with the Psychological General Well Being (PGWB) and Sense of Coherence (SOC) instruments. Demographic, socio-economic and health data were obtained with additional questionnaires. Multiple variance analysis was applied. MAIN OUTCOME MEASURES: The PGWB and SOC scores. RESULTS: After adjustment for seven confounders, the adoption group had higher PGWB scores than the unsuccessful IVF-living without children and the controls and higher SOC scores than all other groups. The unsuccessful IVF-living without children had lower PGWB and SOC scores than all other groups. The PGWB and SOC scores among controls did not differ from those with successful IVF or unsuccessful IVF-living with children. CONCLUSIONS: Adjusted PGWB and SOC scores revealed a high quality of life in the adoption group. However, the group unsuccessful IVF-living without children had low quality of life scores. Quality of life appears to be independent of the outcome of IVF treatment as long as there are children in the family.

Gender perspective on quality of life, comparisons between groups 4-5.5 years after unsuccessful or successful IVF treatment.

OBJECTIVE: To describe and compare quality of life in men and women who had in vitro fertilization (IVF) within the Swedish public health system 4-5.5 years previously, either unsuccessfully and were subsequently living without children, or successfully, having children aged 4-5.5 years. These groups were compared to a control group of men and women with children born at the same time as in the successful group. DESIGN: Cross-sectional study. SETTING: Reproductive Unit, Sahlgrenska University Hospital, Gothenburg, Sweden. SAMPLE: Twenty-six men and 37 women in the unsuccessful group, 135 men and 154 women in the successful group and 93 men and 118 women in the control group. METHODS: Questionnaire study. The respective gender differences were studied in the control and study groups. MAIN OUTCOME MEASURES: Psychological general well-being (PGWB), sense of coherence (SOC), experience of infertility, demographic-socio-economic, and health characteristics. RESULTS: Men in the unsuccessful IVF group scored lower in total PGWB and SOC indices than the successful group men. They reported more depression, lower PGWB and lower SOC than the control group men. Women in the unsuccessful IVF group reported more anxiety, depression, and lower SOC than the successful group women and more depression and lower SOC indices than control group women. Men and women in the unsuccessful IVF group did not differ in any of the parameters. Men in the successful IVF group had higher PGWB, less signs of depression and more self-confidence than women in that group. CONCLUSION: Quality of life in men seems more negatively affected by involuntary infertility than reported in earlier studies.

Quality of life for couples 4-5.5 years after unsuccessful IVF treatment.

OBJECTIVE: To describe quality of life in men and women who had terminated in vitro fertilization (IVF) within the public health system 4-5.5 years previously, and for whom treatment did not result in childbirth. DESIGN: Cross-sectional study. SETTING: Reproductive Unit, Sahlgrenska University Hospital, Gothenburg, Sweden. SAMPLE: Four hundred pairs were invited to participate, 71% accepted and 68% completed questionnaires. METHODS: Questionnaire study. Study subgroups were compared with a control group with children and with each other. MAIN OUTCOME MEASURE: Psychological General Well-Being (PGWB), Sense of Coherence (SOC), experience of infertility, demographic-socio-economic and health characteristics were measured. RESULTS: Surprisingly, 76.7% had or lived together with children; 39.6% had biological children, 34.8% had adopted and 3.7% were parents to both biological and adopted children. No differences were found between the study and the control groups, except in SOC which scored lower in the study group. The study group with children had a higher PGWB index than the 23.3% without children and the controls. SOC scored higher in the subgroup with than those without children. Infertility was still a central issue in the subgroup without children. CONCLUSION: Despite having undergone unsuccessful IVF within the public health system, more than 75% lived with children 4-5.5 years later. This subgroup had a better quality of life, compared to those without children. Additional IVF treatment may result in increased quality of life.

The ESEP study: salpingostomy versus salpingectomy for tubal ectopic pregnancy; the impact on future fertility: a randomised controlled trial.

BACKGROUND: For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP. METHODS/DESIGN: International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation. The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on costs per live birth, including IVF treatment whenever a spontaneous pregnancy does not occur. Patients' preferences will be assessed using a discrete choice experiment. DISCUSSION: This trial will provide evidence on the trade off between salpingostomy and salpingectomy for tubal EP in view of the pros and cons of both interventions and will offer guidance to clinicians in making the right treatment choice. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37002267.