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In this randomized trial involving infertile women with the polycystic ovary syndrome, frozen-embryo transfer was associated with a higher rate of live birth than was fresh-embryo transfer after the first transfer. In vitro fertilization (IVF) is widely performed as an infertility treatment and has resulted in the births of more than 5 million infants worldwide. 1 However, there are concerns about the safety of the procedures for women and for their infants. 1 , 2 The ovarian hyperstimulation syndrome (which is caused by ovarian enlargement, an increase in vascular permeability and abdominal ascites, and intravascular hemoconcentration) is a potentially life-threatening complication of ovarian stimulation. 3 Pregnancies conceived by means of IVF are associated with greater risks of maternal and neonatal complications, including preeclampsia, preterm delivery, low birth weight, and congenital anomalies, than are spontaneous pregnancies. . . .

Background The maximum daily dose of follitropin delta for ovarian stimulation in the first in vitro fertilization cycle is 12 μg (180 IU), according to the algorithm developed by the manufacturer, and based on patient’s ovarian reserve and weight. This study aimed to assess whether 150 IU of menotropin combined with follitropin delta improves the response to stimulation in women with serum antimullerian hormone levels less than 2.1 ng/mL. Methods This study involved a prospective intervention group of 44 women who received 12 μg of follitropin delta combined with 150 IU of menotropin from the beginning of stimulation and a retrospective control group of 297 women who received 12 μg of follitropin delta alone during the phase 3 study of this drug. The inclusion and exclusion criteria and other treatment and follow-up protocols in the two groups were similar. The pituitary suppression was achieved by administering a gonadotropin-releasing hormone (GnRH) antagonist. Ovulation triggering with human chorionic gonadotropin or GnRH agonist and the option of transferring fresh embryos or using freeze-all strategy were made according to the risk of developing ovarian hyperstimulation syndrome. Results Women who received follitropin delta combined with menotropin had higher estradiol levels on trigger day (2150 pg/mL vs. 1373 pg/mL, p  < 0.001), more blastocysts (3.1 vs. 2.4, p  = 0.003) and more top-quality blastocysts (1.8 vs. 1.3, p  = 0.017). No difference was observed in pregnancy, implantation, miscarriage, and live birth rates after the first embryo transfer. The incidence of ovarian hyperstimulation syndrome did not differ between the groups. However, preventive measures for the syndrome were more frequent in the group using both drugs than in the control group (13.6% vs. 0.6%, p  < 0.001). Conclusions In women with serum antimullerian hormone levels less than 2.1 ng/mL, the administration of 150 IU of menotropin combined with 12 μg of follitropin delta improved the ovarian response, making it a valid therapeutic option in situations where ovulation triggering with a GnRH agonist and freeze-all embryos strategy can be used routinely. Trial registration U1111-1247-3260 (Brazilian Register of Clinical Trials, available at https://ensaiosclinicos.gov.br/rg/RBR-2kmyfm ).

Background Adequately selecting the initial follicle-stimulating hormone (FSH) dose during controlled ovarian stimulation (COS) is key for success in assisted reproduction. The objective of COS is to obtain an optimal number of oocytes to increase the chances of achieving a pregnancy, while avoiding complications for the patient. Current clinical protocols do achieve good results for the majority of patients, but further refinements in individualized FSH dosing may reduce the risk of poor ovarian response while also limiting the risk of ovarian hyperstimulation syndrome (OHSS) risk. Models to select the first FSH dose in COS have been presented in literature with promising results. However, most have only been developed and tested in normo-ovulatory women under the age of 40 years. Methods This is a randomized, controlled, multicenter, single blinded, clinical trial. This study will be performed in 236 first cycle in vitro fertilization (IVF) and/or ICSI (intracytoplasmic sperm injection) patients, randomized 1:1 in two arms. In the intervention arm, the dose of FSH will be assigned by a machine learning (ML) model called IDoser, while in the control arm, the dose will be determined by the clinician following standard practice. Stratified block randomization will be carried out depending on the patient being classified as expected low responder, high responder, or normo-responder. Patients will complete their participation in the trial once the first embryo transfer result is known. The primary outcome of the study is the number of metaphase II (MII) oocytes retrieved at ovarian pick up (OPU) and the hypothesis of non-inferiority of the intervention arm compared to the control. Secondary outcomes include the number of cycle cancelations (due to low response or no retrieval of mature oocytes), risk of ovarian hyperstimulation syndrome (OHSS), and clinical pregnancy and live birth rates per first transfer. Discussion To our knowledge, this is the first randomized trial to test clinical performance of an all-patient inclusive model to select the first dose of FSH for COS. Prospective trials for machine learning (ML) models in healthcare are scarce but necessary for clinical application. Trial registration ClinicalTrials.gov, NCT05948293 . Registered on 14 July 2023.

Background This study compared the effectiveness of cabergoline and hydroxychloroquine in preventing ovarian hyperstimulation syndrome (OHSS) in patients with polycystic ovary syndrome (PCOS) undergoing controlled ovarian stimulation. Materials and methods This double-blind, parallel, and randomized clinical trial was performed from April to June 2024. Forty-two patients with PCOS who were candidates for assisted reproductive techniques were randomized into two groups. The first group received 0.5 mg of cabergoline, and the second group received 400 mg of hydroxychloroquine for 8 days. Then, ultrasounds were conducted on days 3 and 5 after oocyte retrieval to assess for OHSS. Results Three and five days after oocyte retrieval, laboratory findings, and clinical outcomes were similar between the cabergoline and hydroxychloroquine groups. Key laboratory parameters, including hemoglobin, hematocrit, sodium, potassium, blood urea nitrogen, and creatinine, did not show significant differences between the groups. On day three, OHSS incidence didn’t have a significant difference between the hydroxychloroquine and cabergoline groups, both for the mild (31.58% vs. 42.86%) and moderate (15.79% vs. 9.52%) groups. Mild cases were observed in one of the patients in both groups 5 days after pickup ( p  = 0.942). No patients in the cabergoline group required hospitalization or treatment, compared to one in the hydroxychloroquine group ( p  = 0.127). Conclusion The incidence of OHSS was similar between cabergoline and hydroxychloroquine, with no significant differences observed in laboratory parameters or clinical outcomes after oocyte retrieval. However, given the study’s sample size, further research is needed before these findings can be generalized to a larger population. Clinical trial number http://www.irct.ir ; Registration number: IRCT20240305061171N1; Registration date: 2024 June 29.

PurposeInvestigating whether pre-ovulatory follicular fluid (FF) levels of selected proteins differ between women who do or do not develop severe ovarian hyperstimulation syndrome (OHSS) and evaluate whether they potentially could guide a “freeze-all” strategy.MethodsFF was collected during a randomized controlled trial comparing OHSS in antagonist versus agonist protocol including 1050 women in their first assisted reproductive technology (ART) cycle during year 2009–2013. The present sub-study is a matched case-control study comparing FF levels of soluble urokinase plasminogen activator receptor (suPAR), C-reactive protein, placental growth factor, vascular endothelial growth factor, and angiopoietins 1 and 2 in OHSS cases (n = 25, severe OHSS, and ≥ 15 oocytes), high-risk controls (n = 25, no OHSS, and ≥ 15 oocytes), and low-risk controls (n = 25, no OHSS, and 5–8 oocytes).ResultsFF level of suPAR differed significantly between the three groups (p = 0.018) with mean (SD) levels of 2.3 (0.4) μg/L, 2.6 (0.8) μg/L, and 2.8 (0.6) μg/L in OHSS cases, high-risk controls, and low-risk controls, respectively. Receiver operating characteristic curve analysis demonstrated that suPAR levels could predict severe OHSS (AUC 0.678; 95% CI 0.553–0.803) with a sensitivity of 64% and a specificity of 66%. None of the other investigated proteins differed between the three groups or between OHSS cases and combined controls.ConclusionThe pre-ovulatory FF level of suPAR was significantly lower in women developing severe OHSS, indicating that the plasminogen activator system could be involved in the pathophysiology of OHSS. However, suPAR did not provide a satisfying predictive value for the prediction of OHSS.

To compare follicular reduction prior to human chorionic gonadotropin (HCG) trigger and coasting in terms of ovarian hyper-stimulation syndrome (OHSS) reduction, pregnancy, and cancellation rates in in vitro fertilization/ intracytoplasmic sperm injection (IVF/ICSI) cycles.  This study was designed as a prospective study. The setting was the IVF unit at King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia. A total of 39 patients undergoing IVF/ICSI cycles, who were at risk of OHSS, 20 were put into a coasting group and 19 had follicular reduction instead. This occurred between October 2010 and January 2011. Our main outcome was OHSS reduction. Six (30%) women developed OHSS in the coasting group and 2 (10.5%) women developed OHSS in the follicular group (p-value=0.235). The pregnancy rates in the cycles were similar for both groups: 4/20 (20%) in the coasting group and 3/19 (15.8%) in the follicular group (p-value=1.000). The cancellation rate of the cycles was similar for both groups, 6/20 (30%) in the coasting group and 1/19 (5.3%) in the follicular group (p-value=0.09). The median number of punctured follicles was significantly lower in the follicular group (16 follicles, interquartile range (IQR)=21-12) compared to the coasting group (29 follicles, IQR=37.8-19.8, p-value=0.001). The retrieved, fertilized, and cleaved oocytes, as well as the number of embryos transferred, were similar amongst both groups. There was no difference between follicular reduction prior to HCG and coasting, in terms of OHSS reduction, pregnancy, and cancellation rates in both the IVF and ICSI cycles.

Purpose To compare the efficacy of cabergoline (Cb2) and intravenous human albumin (HA) in the prevention of ovarian hyperstimulation syndrome. Methods In this randomized controlled trial study, 138 women who were at high risk for developing OHSS were randomly allocated into two groups. In Group one, 20 gr of HA 20% was infused over 1 h. Group two received 0.5 mg per day of Cb2 orally for 7 days, starting on oocyte pickup day. All patients were visited seven and 14 days after oocyte retrieval to determine early clinical or ultrasound evidence of OHSS. Results Moderate OHSS was observed in 33 versus 14 cases in the HA and Cb2 groups, respectively, which was significantly different. The number of severe OHSS cases in the HA group was significantly higher than in the Cb2 group ( P  < 0.001). Conclusions Prophylactic oral low dose cabergoline was more effective and less costly than intravenous human albumin in the prevention of OHSS in high-risk patients. (NCT01009567)

In a multicenter, randomized trial, live-birth rates did not differ significantly according to fresh- or frozen-embryo transfer among ovulatory women with infertility. Frozen-embryo transfer resulted in a lower risk of the ovarian hyperstimulation syndrome.

Elective single embryo transfer (eSET) has been increasingly advocated, but concerns about the lower pregnancy rate after reducing the number of embryos transferred have encouraged transfer of multiple embryos. Extended embryo culture combined with electively freezing all embryos and undertaking a deferred frozen embryo transfer might increase pregnancy rate after eSET. We aimed to establish whether elective frozen single blastocyst transfer improved singleton livebirth rate compared with fresh single blastocyst transfer. This multicentre, non-blinded, randomised controlled trial was undertaken in 21 academic fertility centres in China. 1650 women with regular menstrual cycles undergoing their first cycle of in-vitro fertilisation were enrolled from Aug 1, 2016, to June 3, 2017. Eligible women were randomly assigned to either fresh or frozen single blastocyst transfer. The randomisation sequence was computer generated, with block sizes of two, four, or six, stratified by study site. For those assigned to frozen blastocyst transfer, all blastocysts were cryopreserved and a delayed frozen-thawed single blastocyst transfer was done. The primary outcome was singleton livebirth rate. Analysis was by intention to treat. This trial is registered at the Chinese Clinical Trial Registry, number ChiCTR-IOR-14005405. 825 women were assigned to each group and included in analyses. Frozen single blastocyst transfer resulted in higher rates of singleton livebirth than did fresh single blastocyst transfer (416 [50%] vs 329 [40%]; relative risk [RR] 1·26, 95% CI 1·14–1·41, p<0·0001). The risks of moderate or severe ovarian hyperstimulation syndrome (four of 825 [0·5%] in frozen single blastocyst transfer vs nine of 825 [1·1%] in fresh single blastocyst transfer; p=0·16), pregnancy loss (134 of 583 [23·0%] vs 124 of 481 [25·8%]; p=0·29), other obstetric complications, and neonatal morbidity were similar between the two groups. Frozen single blastocyst transfer was associated with a higher risk of pre-eclampsia (16 of 512 [3·1%] vs four of 401 [1·0%]; RR 3·13, 95% CI 1·06–9·30, p=0·029). Frozen single blastocyst transfer resulted in a higher singleton livebirth rate than did fresh single blastocyst transfer in ovulatory women with good prognosis. The increased risk of pre-eclampsia after frozen blastocyst transfer warrants further studies. The National Key Research and Development Program of China.

Background Ovarian hyperstimulation syndrome is the most severe and life-threatening iatrogenic complication of controlled ovarian stimulation during assisted reproductive technology procedures. Its diagnosis and severity grading are complex. Despite its debilitating and sometimes fatal consequences, there is a paucity of data on early predictors of ovarian hyperstimulation syndrome. Objective This study aimed to identify early predictors of ovarian hyperstimulation syndrome among women undergoing controlled ovarian stimulation for assisted reproductive technology treatment. Methods This prospective cohort study included 46 women undergoing assisted reproductive technology treatment from 1 April to 30 November 2023 at Hallmark Medicals, Kumasi, Ghana. Participants were conveniently recruited and received a standard controlled ovarian stimulation protocol. A structured questionnaire was used to collect sociodemographic and clinical data. Approximately 10 mL of venous blood was collected for laboratory analysis of fibrinogen and cytokine markers as well as hepatic and renal function tests. Statistical analyses were performed using R version 4.3.2 and Statistical Package for the Social Sciences version 26.0. A p-value of <0.05 was considered significant. Results The incidence of ovarian hyperstimulation syndrome among the study cohort was 10.9%, with a higher prevalence (60%) among the 18–24 year age group (p > 0.05) than among other age groups. Fibrinogen and cytokine levels did not differ significantly between the ovarian hyperstimulation syndrome and non-ovarian hyperstimulation syndrome groups; moreover, there was no significant difference in their levels measured before and after controlled ovarian stimulation (p > 0.05). However, receiver operating characteristic analysis revealed that elevated baseline (pre-controlled ovarian stimulation) levels of fibrinogen (area under the curve = 0.567, p = 0.604), interleukin-8 (area under the curve = 0.628, p = 0.337), tumour necrosis factor-alpha (area under the curve = 0.615, p = 0.337) and interleukin-10 (area under the curve = 0.633, p = 0.334) were associated with an increased risk of ovarian hyperstimulation syndrome. Women with elevated baseline interleukin-10 (≥33.5 ng/L) were at higher risk of ovarian hyperstimulation syndrome, with a sensitivity of 80.0%, specificity of 71.8%, area under the curve of 63.3% and an accuracy of 72.7%. Conclusion Interleukin-10 may serve as an early predictor of ovarian hyperstimulation syndrome among women undergoing controlled ovarian stimulation, with high sensitivity, specificity and accuracy. Further large-scale studies are warranted to confirm these findings.