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Article ; Online: Time to stop routine prescription of low-molecular-weight heparin to women with recurrent pregnancy loss and inherited thrombophilia.

Strandell, Annika / Hellgren, Margareta

2023 Volume 402, Issue 10395, Page(s) 6–7

MeSH term(s)	Pregnancy ; Female ; Humans ; Heparin, Low-Molecular-Weight/therapeutic use ; Thrombophilia/complications ; Thrombophilia/drug therapy ; Abortion, Habitual/prevention & control
Chemical Substances	Heparin, Low-Molecular-Weight
Language	English
Publishing date	2023-06-30
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(23)01190-X
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Article ; Online: SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial.

Magarakis, Leonidas / Idahl, Annika / Sundfeldt, Karin / Liv, Per / Pålsson, Mathias / Strandell, Annika

BMJ open

2023 Volume 13, Issue 9, Page(s) e071246

Abstract: Introduction: Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the ... ...

Abstract	Introduction: Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy. Methods and analysis: In SALSTER, a national register-based randomised controlled non-inferiority trial, 968 women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes are Ethics and dissemination: Performing salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316-18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks. Trial registration number: NCT03860805.
MeSH term(s)	Female ; Humans ; Pregnancy ; Cesarean Section ; Multicenter Studies as Topic ; Ovarian Neoplasms/prevention & control ; Ovarian Neoplasms/surgery ; Randomized Controlled Trials as Topic ; Salpingectomy ; Sterilization ; Sweden ; Adult
Language	English
Publishing date	2023-09-04
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-071246
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Article ; Online: HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial.

Idahl, Annika / Liv, Per / Darelius, Anna / Collins, Elin / Sundfeldt, Karin / Pålsson, Mathias / Strandell, Annika

Trials

2023 Volume 24, Issue 1, Page(s) 222

Abstract: Background: The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The ... ...

Abstract	Background: The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The study protocol was first published in January 2019 and is available at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3083-8 . Here, we report amendments made to the study protocol since commencement of the trial. Changes in methods and analysis: The primary outcomes analyses have been changed. (1) Complications will be analyzed using binomial generalized estimating equation (GEE) with log link function, while the unadjusted analyses according to Miettinen and Nurminen will be performed as a sensitivity analysis. (2) Absolute change in Menopause Rating Scale (MRS) will primarily be analyzed using a mixed effects model, adjusted for baseline MRS and center as a random effect. (3) Time to EOC will be analyzed using the mixed effects Cox regression model with center as random effect, while the unadjusted log-rank test will be performed as a sensitivity analysis. The primary outcome Complications will be based solely on the specific assessment in the GynOp quality registry. The Clavien-Dindo classification will be evaluated as a secondary outcome. Furthermore, MRS is also measured three years postoperatively to better pinpoint the onset of menopausal symptoms. Discussion: The changes to the protocol mainly concern the analyses of data. No changes to recruitment, randomization, intervention, or follow-up of primary outcomes have been made. An interim analysis during 2021 concluded that the study should continue until the target sample size is reached. Trial registration: ClinicalTrials.gov, NCT03045965 . Registered 8 February 2017.
MeSH term(s)	Female ; Humans ; Carcinoma, Ovarian Epithelial/surgery ; Hysterectomy/adverse effects ; Hysterectomy/methods ; Salpingectomy/adverse effects ; Salpingectomy/methods ; Ovarian Neoplasms/surgery ; Registries ; Treatment Outcome ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
Language	English
Publishing date	2023-03-24
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07244-w
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Article ; Online: Efficacy and safety of sterilisation procedures to reduce the risk of epithelial ovarian cancer: a systematic review comparing salpingectomy with tubal ligation.

Magarakis, Leonidas / Idahl, Annika / Särnqvist, Charlotte / Strandell, Annika

The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception

2021 Volume 27, Issue 3, Page(s) 230–239

Abstract: Purpose: The objective of this systematic review is to evaluate current literature comparing salpingectomy for sterilisation with tubal ligation, regarding the effectiveness and safety, and assess the certainty of evidence.: Materials and methods: ... ...

Abstract	Purpose: The objective of this systematic review is to evaluate current literature comparing salpingectomy for sterilisation with tubal ligation, regarding the effectiveness and safety, and assess the certainty of evidence. Materials and methods: PubMed, Cochrane, and Embase databases were searched. Randomised (RCT) and observational studies were included. Articles were quality assessed and data extracted by two independent authors. Certainty of evidence was assessed using GRADE. Results: Of 2020 articles, 17 were included. No study investigated the risk of EOC. No difference in anti-Müllerian hormone was reported in one RCT at caesarean section (CS). Two cohort studies evaluated ovarian function with surrogate measures and found no difference at caesarean section. Complications did not differ but were inconsistently reported. Laparoscopic tubal ligation was 7 min faster (95% CI 3.8-10.5). Operative time at caesarean section was dependent on the use of surgical devices. Certainty of evidence was low or very low for all estimates, indicating knowledge gaps. Reliable safety data on salpingectomy for sterilisation is lacking, and there is no effectiveness data. Presently, women cannot be properly counselled regarding salpingectomy for sterilisation.
MeSH term(s)	Carcinoma, Ovarian Epithelial ; Cesarean Section ; Female ; Humans ; Ovarian Neoplasms/prevention & control ; Ovarian Neoplasms/surgery ; Pregnancy ; Salpingectomy/methods ; Sterilization ; Sterilization, Tubal/methods
Language	English
Publishing date	2021-12-06
Publishing country	England
Document type	Journal Article ; Systematic Review
ZDB-ID	1397560-2
ISSN	1473-0782 ; 1362-5187
ISSN (online)	1473-0782
ISSN	1362-5187
DOI	10.1080/13625187.2021.2010041
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Article ; Online: Pregnancy of unknown location: external validation of the hCG-based M6NP and M4 prediction models in an emergency gynaecology unit.

Fistouris, Johan / Bergh, Christina / Strandell, Annika

BMJ open

2022 Volume 12, Issue 11, Page(s) e058454

Abstract: Objective: To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4.: Design: Retrospective cohort study.: ... ...

Abstract	Objective: To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4. Design: Retrospective cohort study. Setting: University Hospital. Participants: Women with PUL. Methods: All consecutive women with a PUL during a study period of 3 years were screened for inclusion. Risk prediction of an EP was based on two serum human chorionic gonadotropin (hCG) levels taken at least 24 hours and no longer than 72 hours apart. Main outcome measures: The area under the ROC curve (AUC) expressed the ability of a model to distinguish an EP from a non-EP (discrimination). Calibration assessed the agreement between the predicted risk of an EP and the true risk (proportion) of EP. The proportion of EPs and non-EPs classified as high risk assessed the model's sensitivity and false positive rate (FPR). The proportion of non-EPs among women classified as low risk was the model's negative predictive value (NPV). The clinical utility of a model was evaluated with decision curve analysis. Results: 1061 women were included in the study, of which 238 (22%) had a final diagnosis of EP. The AUC for EP was 0.85 for M6NP and 0.81 for M4. M6NP made accurate risk predictions of EP up to predictions of 20% but thereafter risks were underestimated. M4 was poorly calibrated up to risk predictions of 40%. With a 5% threshold for high risk classification the sensitivity for EP was 95% for M6NP, the FPR 50% and NPV 97%. M6NP had higher sensitivity and NPV than M4 but also a higher FPR. M6NP had utility at all thresholds as opposed to M4 that had no utility at thresholds≤5%. Conclusions: M6NP had better predictive performance than M4 and is valid in women with PUL attending an emergency gynaecology unit. Our results can encourage implementation of M6NP in related yet untested clinical settings to effectively support clinical decision-making.
MeSH term(s)	Pregnancy ; Humans ; Female ; Gynecology ; Retrospective Studies ; Pregnancy, Ectopic/diagnosis ; Area Under Curve ; Calibration
Language	English
Publishing date	2022-11-29
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-058454
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Article ; Online: Fertility preservation and fertility treatment in transgender adolescents and adults in a Swedish region, 2013-2018.

Mattelin, Ellenor / Strandell, Annika / Bryman, Inger

Human reproduction open

2022 Volume 2022, Issue 2, Page(s) hoac008

Abstract: Study question: In a transgender population referred for fertility consultation, which factors influence the decision to cryopreserve oocytes and sperm?: Summary answer: Previous hormonal treatment, gender affirmation surgery and sexual orientation ... ...

Abstract	Study question: In a transgender population referred for fertility consultation, which factors influence the decision to cryopreserve oocytes and sperm? Summary answer: Previous hormonal treatment, gender affirmation surgery and sexual orientation were associated with the decision to undergo fertility preservation and transgender women underwent fertility preservation more frequently than transgender men. What is known already: It is well-known internationally that fertility preservation and fertility treatment are increasingly requested by transgender men and women. Factors affecting their decisions as well as treatment differences between transgender women and transgender men have been reported, but many studies have had low participation rates and small sample sizes. Study design size duration: This retrospective cohort study, conducted during 2013-2018, included 78 transgender women (assigned male at birth and referred for sperm cryopreservation) and 164 transgender men (assigned female at birth referred for oocyte cryopreservation). Participants/materials setting methods: In 2013, the previous requirement for sterilization before completion of a legal gender change was removed in Sweden. All fertile-aged transgender men and transgender women referred to a tertiary care centre for consultation concerning fertility preservation, fertility treatment or hysterectomy were identified from administrative systems. Demographic, medical and treatment data were extracted from electronic medical records and from an ART database. Logistic regression was applied to analyse factors affecting the decision to cryopreserve gametes among transgender men and transgender women. Main results and the role of chance: A majority of transgender men (69.5%) and transgender women (82%), wanted to become parents. Fertility preservation was less frequent in transgender men than in transgender women (26.2% versus 75.6%, respectively). No individuals among those primarily referred for hysterectomy opted for cryopreservation of oocytes. Among transgender men, young age, no previous hormonal treatment and stating homosexual orientation were independent factors associated with the decision to cryopreserve oocytes. Among transgender women, the decision to undergo gender affirmation surgery and stating heterosexual orientation were independent factors associated with a decision to refrain from fertility preservation. Fertility treatments, using IUI or IVF with donor sperm, were mainly performed in partners of transgender men. Ten live births were reported in the group of transgender men and two for transgender women. Limitations reasons for caution: The main limitation is the retrospective nature of the study, with missing data for many variables. The short study period and the study population being too young to permit observation of long-term outcomes of fertility preservation and fertility treatments are reasons for caution. Wider implications of the findings: Our results confirm that fertility preservation has been requested by transgender people since the change in Swedish legislation in 2013. Information about aspects of fertility early in the transition process is important, since hormonal and surgical treatments may have a large impact on the decision to undergo fertility preservation. It is important to train fertility clinic staff to identify and handle the specific obstacles, as well as address the need for information and support that transgender people may have when planning for fertility preservation, fertility treatment and pregnancy. Study funding/competing interests: This research was supported by a grant from the Swedish state, under the ALF agreement between the Swedish government and the county councils (ALFGBG-720291), and by Hjalmar Svensson's Research Foundation. None of the authors has any conflict of interest to declare. Trial registration number: N/A.
Language	English
Publishing date	2022-02-21
Publishing country	England
Document type	Journal Article
ISSN	2399-3529
ISSN (online)	2399-3529
DOI	10.1093/hropen/hoac008
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Article ; Online: HOPPSA update

Annika Idahl / Per Liv / Anna Darelius / Elin Collins / Karin Sundfeldt / Mathias Pålsson / Annika Strandell

Trials, Vol 24, Iss 1, Pp 1-

changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

2023 Volume 5

Abstract: Abstract Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC) ...

Abstract	Abstract Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The study protocol was first published in January 2019 and is available at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3083-8 . Here, we report amendments made to the study protocol since commencement of the trial. Changes in methods and analysis The primary outcomes analyses have been changed. (1) Complications will be analyzed using binomial generalized estimating equation (GEE) with log link function, while the unadjusted analyses according to Miettinen and Nurminen will be performed as a sensitivity analysis. (2) Absolute change in Menopause Rating Scale (MRS) will primarily be analyzed using a mixed effects model, adjusted for baseline MRS and center as a random effect. (3) Time to EOC will be analyzed using the mixed effects Cox regression model with center as random effect, while the unadjusted log-rank test will be performed as a sensitivity analysis. The primary outcome Complications will be based solely on the specific assessment in the GynOp quality registry. The Clavien-Dindo classification will be evaluated as a secondary outcome. Furthermore, MRS is also measured three years postoperatively to better pinpoint the onset of menopausal symptoms. Discussion The changes to the protocol mainly concern the analyses of data. No changes to recruitment, randomization, intervention, or follow-up of primary outcomes have been made. An interim analysis during 2021 concluded that the study should continue until the target sample size is reached. Trial registration ClinicalTrials.gov, NCT03045965 . Registered 8 February 2017.
Keywords	HOPPSA ; Opportunistic salpingectomy ; Hysterectomy ; Complications ; Menopausal symptoms ; Ovarian cancer ; Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
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Article ; Online: SALpingectomy for STERilisation (SALSTER)

Per Liv / Annika Strandell / Karin Sundfeldt / Annika Idahl / Leonidas Magarakis / Mathias Pålsson

BMJ Open, Vol 13, Iss

study protocol for a Swedish multicentre register-based randomised controlled trial

2023 Volume 9

Abstract: Introduction Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the ... ...

Abstract	Introduction Salpingectomy is currently suggested as an alternative to tubal ligation for sterilisation. Precursor lesions of ovarian carcinoma can be found in the fallopian tubes; thus, salpingectomy could possibly reduce the incidence. Most of the existing trials on safety are small, on caesarean section and report on surrogate ovarian function measures. Randomised trials in laparoscopy are lacking. Well-designed trials are needed to evaluate safety of laparoscopic opportunistic salpingectomy.Methods and analysis In SALSTER, a national register-based randomised controlled non-inferiority trial, 968 women <50 years, wishing laparoscopic sterilisation will be randomised to either salpingectomy or tubal ligation. The Swedish National Quality Register of Gynecological Surgery (GynOp) will be used for inclusion, randomisation and follow-up. Primary outcomes are any complication up to 8 weeks postoperatively, and age at menopause. Both outcomes are measured with questionnaires, complications are also assessed by a gynaecologist. In a nested trial, ovarian function will be evaluated comparing the mean difference of anti-Müllerian hormone (AMH), assessed preoperatively and 1 year after surgery.Ethics and dissemination Performing salpingectomy for sterilisation has become increasingly common, despite the unclear risk-benefit balance. SALSTER studies the safety of salpingectomy compared with tubal ligation. Regardless of the result, SALSTER will provide gynaecologists with high quality evidence to inform women to decide on salpingectomy or not. The central ethical review board of Gothenburg, Sweden (Dnr. 316–18) approved the trial in 2018. Results will be presented at scientific congresses and published in peer-reviewed scientific journals. The results will be communicated through professional organisations and research networks.Trial registration number NCT03860805.
Keywords	Medicine ; R
Subject code	170
Language	English
Publishing date	2023-09-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Comprehensive evidence on assisted reproductive technologies.

Strandell, Annika

The Cochrane database of systematic reviews

2014 , Issue 1, Page(s) ED000077

MeSH term(s)	Databases, Bibliographic ; Humans ; Infertility/therapy ; Reproductive Techniques, Assisted/standards ; Review Literature as Topic
Language	English
Publishing date	2014-01-14
Publishing country	England
Document type	Editorial ; Comment
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.ED000077
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Article ; Online: Pregnancy of unknown location

Christina Bergh / Annika Strandell / Johan Fistouris

BMJ Open, Vol 12, Iss

external validation of the hCG-based M6NP and M4 prediction models in an emergency gynaecology unit

2022 Volume 11

Abstract: Objective To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4.Design Retrospective cohort study.Setting ... ...

Abstract	Objective To investigate if M6NP predicting ectopic pregnancy (EP) among women with pregnancy of unknown location (PUL) is valid in an emergency gynaecology setting and comparing it with its predecessor M4.Design Retrospective cohort study.Setting University Hospital.Participants Women with PUL.Methods All consecutive women with a PUL during a study period of 3 years were screened for inclusion. Risk prediction of an EP was based on two serum human chorionic gonadotropin (hCG) levels taken at least 24 hours and no longer than 72 hours apart.Main outcome measures The area under the ROC curve (AUC) expressed the ability of a model to distinguish an EP from a non-EP (discrimination). Calibration assessed the agreement between the predicted risk of an EP and the true risk (proportion) of EP. The proportion of EPs and non-EPs classified as high risk assessed the model’s sensitivity and false positive rate (FPR). The proportion of non-EPs among women classified as low risk was the model’s negative predictive value (NPV). The clinical utility of a model was evaluated with decision curve analysis.Results 1061 women were included in the study, of which 238 (22%) had a final diagnosis of EP. The AUC for EP was 0.85 for M6NP and 0.81 for M4. M6NP made accurate risk predictions of EP up to predictions of 20% but thereafter risks were underestimated. M4 was poorly calibrated up to risk predictions of 40%. With a 5% threshold for high risk classification the sensitivity for EP was 95% for M6NP, the FPR 50% and NPV 97%. M6NP had higher sensitivity and NPV than M4 but also a higher FPR. M6NP had utility at all thresholds as opposed to M4 that had no utility at thresholds≤5%.Conclusions M6NP had better predictive performance than M4 and is valid in women with PUL attending an emergency gynaecology unit. Our results can encourage implementation of M6NP in related yet untested clinical settings to effectively support clinical decision-making.
Keywords	Medicine ; R
Subject code	610
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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