Physical Exercise following bariatric surgery in women with Morbid obesity Study protocol clinical trial (SPIRIT compliant)

Background: Severe and morbid obesity are increasing globally, particularly in women. As BMI increases, the likelihood of anovulation is higher. The primary aim of the EMOVAR clinical trial is to examine, over the short (16 weeks) and medium (12 months) term, the effects of a supervised physical exercise program (focused primarily on aerobic and resistance training) on ovarian function in women with severe/morbid obesity who have undergone bariatric surgery. Secondary objectives are to examine the effects of the intervention on chronic inflammation, insulin resistance, arterial stiffness, physical fitness, and health-related quality of life. Methods: This is a randomized controlled trial in which ∼40 female bariatric surgery patients, aged between 18 and 45 years old, will be included. Participants assigned to the experimental group will perform a total of 48 sessions of supervised concurrent (strength and aerobic) training (3sessions/week, 60min/session) spread over 16 weeks. Patients assigned to the control group will receive lifestyle recommendations. Outcomes will be assessed at baseline, week 16 (i.e., after the exercise intervention) and 12 months after surgery. The primary outcome is ovarian function using the Sex-Hormone Binding Globuline, measured in serum. Secondary outcomes are serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale). Other secondary outcomes include serummarkers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6, tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and theHOMA-IR), arterial stiffness, systolic, diastolic and mean blood pressure, body composition, and total weight loss. Physical fitness (including cardiorespiratory fitness, muscular strength, and flexibility), health-related quality of life (SF-36 v2) and sexual function (Female Sexual Function Index) will also be measured. Discussion: This study will provide, for the first time, relevant information on the effects of exercise training on ovarian function and underlying mechanisms in severe/morbid obese women following bariatric surgery.This work was supported by Ministerio de Economía y Competitividad (MINECO), Plan Nacional de I+D+i call RETOS 2018 (grant n° RTI2018-093302-A-I00). EM-R was funded by the Spanish Ministry of Science, Innovation and Universities (FPU18/01107) and AH-M by the Gerty Cory pre-doctoral program for deficit areas at the University of Almería

A New Beginning : Young Women's Experiences and Sexual Function 18 Months After Bariatric Surgery

Introduction: Female patients expect improved quality of life, including sexual health and regain of fertility after bariatric surgery. Little has been published on to the extent to which patients’ expectations are met by the weight loss after surgery. Aim: To explore how women perceive the effects of bariatric surgery on quality of life, focusing on sexual health and fertility. Methods: A qualitative study based on thematic analysis, supported by questionnaire data. Interviews following a semistructured guide were conducted with childless women (n = 11) aged 25–34 years recruited from a university-affiliated Swedish bariatric center. The interviews took place 18 months after surgery in the participants’ homes or at the hospital and were recorded and transcribed verbatim. Data were analyzed with a thematic approach. Questionnaires were filled in at the time of the interviews and compared with preoperative data using a Wilcoxon test for paired data. Main outcome measures: Participants described experiences related to female sexual health after bariatric surgery. The Hospital Anxiety and Depression Scale and the Female Sexual Function Index questionnaires were administered preoperatively and postoperatively. Results: “A new beginning” was identified as the master theme, with 3 underlying subthemes: “Being worthy of love,” “Exploring sexuality,” and “Considering parenthood.” The participants described a transformation into being more comfortable with themselves that affected all areas of life, including sexual life. These findings were supported by lower scores for depression, 6.5 vs 2, and improved total Female Sexual Function Index scores, median 23.3 preoperatively and 29.1 postoperatively, P = .012. Conclusions: Improved body image and enhanced self-esteem play important roles in improved sexual functioning in women after bariatric surgery. Nilsson-Condori E, Järvholm S, Thurin-Kjellberg A, et al. A New Beginning: Young Women's Experiences and Sexual Function 18 Months After Bariatric Surgery

Outcomes of in-vitro fertilization after bariatric surgery : a national register-based case-control study

STUDY QUESTION: Does previous bariatric surgery (BS) in women affect cumulative live birth rate in IVF?SUMMARY ANSWER: Women having had BS seem to have the same cumulative live birth rate as non-operated women of the same BMI at IVF treatment.WHAT IS KNOWN ALREADY: Because of the perinatal risks of obesity to mother and infant as well as impaired outcomes of IVF, obese women are advised to reduce their weight, but it is not clear whether previous BS could affect IVF results.STUDY DESIGN, SIZE, DURATION: This national register-based case-control study included all cases of BS (n = 30 436) undergoing IVF (n = 153) from 2007 until 2017.PARTICIPANTS/MATERIALS, SETTING, METHODS: Swedish women between 18 and 45 years operated with BS, with at least one first started cycle of IVF after surgery, were included. For each woman having IVF after BS (n = 153), up to five non-operated control women (n = 744) starting their first IVF cycle during the study period were matched for age, parity and BMI at treatment. The primary outcome in this study was the cumulative live birth rate (CLBR) after the first IVF cycle, defined as all live births after the first cycle including fresh and frozen embryo transfers.MAIN RESULTS AND THE ROLE OF CHANCE: There was no significant difference in CLBR between the BS group and the matched controls (29.4% compared to 33.1%), even though the number of retrieved oocytes (7.6 vs 8.9, P = 0.005) and frozen embryos (1.0 vs 1.5, P = 0.041) were significantly fewer in the BS group. There was no association between cumulative live birth and BS, adjusted odds ratio 1.04, 95% CI (0.73, 1.51). However, the birth weight was significantly lower in the children born to mothers with previous BS, mean (SD) 3190 (690) vs 3478 (729) g, P = 0.037.LIMITATIONS, REASONS FOR CAUTION: Confounders such as age, BMI and previous childbirth were accounted for by the matching design of the study, but there were no data on indication for IVF, anti-Müllerian hormone, smoking or previous comorbidities. The study was exploratory and did not reach sufficient power to detect potential smaller differences in live birth rates.WIDER IMPLICATIONS OF THE FINDINGS: The findings concur with those in previously published smaller studies and provide somewhat reassuring results considering IVF outcomes after BS with a CLBR comparable to that of controls, despite a lower mean birth weight.STUDY FUNDING/COMPETING INTEREST(S): This research was funded by grants from the Southern Health Care Region of Sweden. The authors have no competing interests to declare.TRIAL REGISTRATION NUMBER: N/A

Infertility, pregnancy loss and assisted reproduction in women with asthma : a population-based cohort study

STUDY QUESTION: Is the chance of childbirth, and risk of infertility, pregnancy loss and need for assisted reproduction different for women with asthma compared to women without asthma?SUMMARY ANSWER: Women with asthma had comparable chances of giving birth compared to the reference population, however, their risk of both infertility and pregnancy loss, as well their need for medically assisted reproduction, was higher.WHAT IS KNOWN ALREADY: Reproductive dysfunction has been reported among women with asthma, including longer time to pregnancy, increased risk of pregnancy loss and a higher need of medically assisted reproduction, but their risk of clinical infertility is unknown.STUDY DESIGN, SIZE, DURATION: This longitudinal register-based cohort study included all women with a healthcare visit for delivery, infertility, pregnancy loss or induced abortion in the southernmost county in Sweden, over the last 20 years.PARTICIPANTS/MATERIALS, SETTING, METHODS: Using the Skåne Healthcare Register, we identified all women aged 15-45 between 1998 and 2019, who received a diagnosis of asthma before their first reproductive outcome (n = 6445). Chance of childbirth and risk of infertility, pregnancy loss and assisted reproduction were compared to a healthcare seeking population of women without any asthma (n = 200 248), using modified Poisson regressions.MAIN RESULTS AND THE ROLE OF CHANCE: The chance of childbirth was not different between women with asthma versus those without, adjusted risk ratio (aRR) = 1.02, 95% CI: 1.01-1.03. The risk of seeking care for infertility was increased, aRR = 1.29, 95% CI: 1.21-1.39, and women with asthma more often needed assisted reproduction aRR = 1.34 95% CI: 1.18-1.52. The risk of suffering a pregnancy loss was higher, aRR = 1.21, 95% CI: 1.15-1.28, and induced abortions were more common, aRR = 1.15, 95% CI: 1.11-1.20, among women with asthma.LIMITATIONS, REASONS FOR CAUTION: The study was an observational study based on healthcare visits and lacked detailed anthropometric data, thus residual confounding cannot be excluded. Only women with a healthcare visit for a reproductive outcome were included, which cannot be translated into pregnancy intention. A misclassification, presumed to be non-differential, may arise from an incorrect or missing diagnosis of asthma or female infertility, biasing the results towards the null.WIDER IMPLICATIONS OF THE FINDINGS: This study points towards reproductive dysfunction associated with asthma, specifically in regards to the ability to maintain a pregnancy and the risk of needing medically assisted reproduction following clinical infertility, but reassuringly the chance of subsequently giving birth was not lower for these women.STUDY FUNDING/COMPETING INTEREST(S): This article is part of the ReproUnion collaborative study, co-financed by EU Interreg ÖKS, Capital Region of Denmark, Region Skåne and Ferring Pharmaceuticals. The authors have no competing interests to disclose.TRIAL REGISTRATION NUMBER: N/A

Fertility outcomes in women with pre-existing type 2 diabetes-a prospective cohort study

OBJECTIVE: To study childbirth and the risk of miscarriage and infertility among women who have received a diagnosis of type 2 diabetes before the start of their reproductive journey. DESIGN: Register-based cohort study using the Skåne Healthcare Register SETTING: All healthcare visits for the whole population of the southernmost region in Sweden over the past 20 years PATIENT(S): All women who were aged 18-45 years between January 1, 1998 and December 31, 2019 and who received a clinical diagnosis of type 2 diabetes before their first childbirth, miscarriage, or infertility diagnosis (n = 230) were compared with a healthcare-seeking population of women without any type of diabetes, matched for calendar year and age (n = 179,434). INTERVENTION(S): None MAIN OUTCOME MEASURE(S): Childbirth, miscarriage, and infertility diagnosis RESULT(S): The birthrate was lower among women with type 2 diabetes (62.6% vs. 83.8%), and they were less likely to give birth (crude risk ratio [RR] = 0.73, 95% confidence interval [CI]: 0.66-0.81). They had a higher risk of experiencing a miscarriage (RR = 1.88, 95% CI: 1.50-2.36). The risk of infertility was increased (RR = 3.44, 95% CI: 2.88-4.10) as was the risk of having infertility and not giving birth (RR = 4.47, 95% CI: 3.44-5.82). All results remained the same after adjustment for polycystic ovary syndrome and obesity. CONCLUSION(S): Women with type 2 diabetes with onset before their reproductive journey were more often childless compared with women without diabetes and had a higher risk of experiencing both miscarriage and infertility. This patient group may be in need of targeted information regarding potential fertility issues as part of their clinical treatment