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Testosterone therapy for women with poor ovarian response undergoing IVF: a meta-analysis of randomized controlled trials.

ABSTRACT: PURPOSE:The aim of the present systematic review and meta-analysis was to summarize evidence on the effectiveness of testosterone supplementation for poor ovarian responders (POR) on IVF outcomes. The primary outcome was live birth rate (LBR); secondary outcomes were clinical pregnancy rate (CPR), miscarriage rate (MR), total and MII oocytes, and total embryos. METHODS:This meta-analysis of randomized controlled trials (RCTs) evaluates the effects of testosterone administration before/during COS compared with a control group in patients defined as POR. The primary outcome was live birth rate (LBR); secondary outcomes were clinical pregnancy rate (CPR), miscarriage rate (MR), total and MII oocytes, and total embryos. Pooled results were expressed as risk ratio (RR) or mean differences (MD) with 95% confidence interval (95% CI). Sources of heterogeneity were investigated through sensitivity and subgroup analysis. All analyses were performed by using the random-effects model. RESULTS:Women receiving testosterone showed higher LBR (RR 2.29, 95% CI 1.31-4.01, p?=?0.004), CPR (RR 2.32, 95% CI 1.47-3.64, p?=?0.0003), total oocytes (MD?=?1.28 [95% CI 0.83, 1.73], p?

SUBMITTER: Noventa M

PROVIDER: S-EPMC6505000 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Testosterone therapy for women with poor ovarian response undergoing IVF: a meta-analysis of randomized controlled trials.

Noventa Marco M Vitagliano Amerigo A Andrisani Alessandra A Blaganje Mija M Viganò Paola P Papaelo Enrico E Scioscia Marco M Cavallin Francesco F Ambrosini Guido G Cozzolino Mauro M

Journal of assisted reproduction and genetics 20190105 4

<h4>Purpose</h4>The aim of the present systematic review and meta-analysis was to summarize evidence on the effectiveness of testosterone supplementation for poor ovarian responders (POR) on IVF outcomes. The primary outcome was live birth rate (LBR); secondary outcomes were clinical pregnancy rate (CPR), miscarriage rate (MR), total and MII oocytes, and total embryos.<h4>Methods</h4>This meta-analysis of randomized controlled trials (RCTs) evaluates the effects of testosterone administration be ...[more]

PMID: 30610664

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Project description:IntroductionAge, polycystic ovary syndrome (PCOS), low body mass index (BMI), high antral follicle count (AFC), increased anti-Muller hormone (AMH) levels, and elevated serum estradiol (E2) concentrations are risk factors for ovarian hyperstimulation syndrome (OHSS). However, data on the relationship between risk factors and OHSS severity in patients with PCOS are rare.ObjectiveThis retrospective study examined the risk factors for OHSS and their effect on OHSS severity in patients with PCOS undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).MethodThe records of 2,699 women were reviewed and included in this study. These women were diagnosed with PCOS during their first IVF/ICSI cycle between January 2010 and December 2017. We analyzed the association between each of the interrogated risk factors (including female age, BMI, AFC, basal serum E2, and the number of oocytes retrieved) and OHSS. The effects of each risk factor on OHSS severity were further explored. Logistic regression was performed as part of the above analysis.ResultsOf the 2,699 women with PCOS who underwent assisted reproductive technology (ART), 75.2% had a normal response to controlled ovarian hyperstimulation (COH), while 24.8% developed OHSS. All OHSS patients were younger and had lower BMIs and basal serum follicle-stimulating hormone (FSH) and E2 levels but higher AFCs than those in the normal group. AFC demonstrated a strong correlation with OHSS, with a cutoff value of 24 in patients with PCOS. A total of 19.5% of the patients had mild OHSS, while 80.5% had moderate OHSS. Compared with those in the moderate OHSS group, those in the mild OHSS group were older and had higher basal serum FSH levels and lower serum E2 and T levels. However, BMI and AFC were not different between the mild and moderate OHSS groups. Basal serum E2 showed a strong correlation with OHSS severity, with a cutoff value of 37.94 pg/ml.ConclusionsAFC is a strong marker of OHSS, and basal serum E2 is the best predictor of OHSS severity in women with PCOS undergoing IVF treatment.

Project description:BackgroundSince the introduction of assisted reproductive technologies in 1978, over 2 million in vitro fertilization (IVF) babies have been born worldwide. Patients play a vital role in the success of this treatment. They are required to take fertility medication (hormone injections) to activate the ovaries to produce a sufficient number of oocytes. Later, they need to take medication to increase the chance of the embryo surviving inside the uterus. Patients are educated during an intake consultation at the start of the treatment to minimize the emotional burden and reduce noncompliance. The consultation lasts about 30 to 45 minutes and covers all essential subjects. Even though ample time and energy is spent on patient education, patients still feel anxious, unknowledgeable, and unsupported. As such, electronic health utilizing a smartphone or tablet app can offer additional support, as it allows health care professionals to provide their patients with the correct information at the right time by using push notifications.ObjectiveThis randomized controlled trial aimed to evaluate the capacity of an app to support IVF patients throughout the different phases of their treatment and assess its effectiveness. The study's primary outcome was to determine the patients' level of satisfaction with the information provided. The secondary outcomes included their level of knowledge, ability to administer the medication, overall experienced quality of the treatment, health care consumption, and app usage.MethodsThis study was performed at a specialized fertility clinic of the nonacademic teaching hospital Elisabeth-TweeSteden Ziekenhuis in Tilburg, the Netherlands. Patients who were scheduled for IVF or intracytoplasmic sperm injection treatments between April 2018 and August 2019 were invited to participate in a physician-blinded, randomized controlled trial.ResultsIn total, 54 patients participated (intervention group: n=29). Patients in the intervention group demonstrated a higher level of satisfaction on a 0 to 10 scale (mean 8.43, SD 1.03 vs mean 7.70, SD 0.66; P=.004). In addition, they were more knowledgeable about the different elements of the treatment on a 7 to 35 scale (mean 27.29, SD 2.94 vs mean 23.05, SD 2.76; P<.001). However, the difference disappeared over time. There were no differences between the two patient groups on the other outcomes. In total, 25 patients in the intervention group used the app 1425 times, an average of 57 times per patient.ConclusionsOur study demonstrates that, in comparison with standard patient education, using an app to provide patients with timely information increases their level of satisfaction. Furthermore, using the app leads to a higher level of knowledge about the steps and procedures of IVF treatment. Finally, the app's usage statistics demonstrate patients' informational needs and their willingness to use an electronic health application as part of their treatment.Trial registrationNetherlands Trial Register (NTR) 6959; https://www.trialregister.nl/trial/6959.

Project description:IntroductionThe results of a recent meta-analysis showed that adding recombinant human luteinising hormone (r-hLH) to recombinant human follicle-stimulating hormone (r-hFSH) for ovarian stimulation was beneficial in poor responders, resulting in a 30% relative increase in the clinical pregnancy rate compared with r-hFSH monotherapy. However, a limitation of the meta-analysis was that the included studies used heterogeneous definitions of poor ovarian response (POR). Furthermore, the use of r-hLH supplementation during ovarian stimulation is a topic of ongoing debate, and well-designed, adequately powered, multicentre, randomised controlled trials in this setting are warranted. Therefore, the objective of the ESPART trial is to explore the possible superiority of a fixed-dose combination of r-hFSH plus r-hLH over r-hFSH monotherapy in patients with POR, as per a definition aligned with the European Society of Human Reproduction and Embryology (ESHRE) Bologna criteria.Methods and analysisPhase III, randomised, single-blind, parallel-group trial in women undergoing in vitro fertilisation and/or intracytoplasmic sperm injection. Approximately 946 women aged 18-<41 years from 18 countries will be randomised (1:1) to receive a fixed-dose combination of r-hFSH plus r-hLH in a 2:1 ratio (Pergoveris) or r-hFSH monotherapy (GONAL-f). The primary end point is the total number of retrieved oocytes per participant. Secondary end points include: ongoing pregnancy rate, live birth rate, implantation rate, biochemical pregnancy rate and clinical pregnancy rate. Safety end points include: incidence and severity of ovarian hyperstimulation syndrome, and of adverse events and serious adverse events.Ethics and disseminationThe study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki, with the International Conference on Harmonisation-Good Clinical Practice guidelines and all applicable regulatory requirements. All participants will provide written informed consent prior to entry. The results of this study will be publically disseminated.Trial registration numbersClinicalTrials.gov identifier: NCT02047227; EudraCT Number: 2013-003817-16; Clinical Trial Protocol Number: EMR200061-005 V.3.0, 15 April 2014.

Project description:BACKGROUND: Testosterone therapy is increasingly promoted. No randomized placebo-controlled trial has been implemented to assess the effect of testosterone therapy on cardiovascular events, although very high levels of androgens are thought to promote cardiovascular disease. METHODS: A systematic review and meta-analysis was conducted of placebo-controlled randomized trials of testosterone therapy among men lasting 12+ weeks reporting cardiovascular-related events. We searched PubMed through the end of 2012 using "("testosterone" or "androgen") and trial and ("random*")" with the selection limited to studies of men in English, supplemented by a bibliographic search of the World Health Organization trial registry. Two reviewers independently searched, selected and assessed study quality with differences resolved by consensus. Two statisticians independently abstracted and analyzed data, using random or fixed effects models, as appropriate, with inverse variance weighting. RESULTS: Of 1,882 studies identified 27 trials were eligible including 2,994, mainly older, men who experienced 180 cardiovascular-related events. Testosterone therapy increased the risk of a cardiovascular-related event (odds ratio (OR) 1.54, 95% confidence interval (CI) 1.09 to 2.18). The effect of testosterone therapy varied with source of funding (P-value for interaction 0.03), but not with baseline testosterone level (P-value for interaction 0.70). In trials not funded by the pharmaceutical industry the risk of a cardiovascular-related event on testosterone therapy was greater (OR 2.06, 95% CI 1.34 to 3.17) than in pharmaceutical industry funded trials (OR 0.89, 95% CI 0.50 to 1.60). CONCLUSIONS: The effects of testosterone on cardiovascular-related events varied with source of funding. Nevertheless, overall and particularly in trials not funded by the pharmaceutical industry, exogenous testosterone increased the risk of cardiovascular-related events, with corresponding implications for the use of testosterone therapy.

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Testosterone therapy for women with poor ovarian response undergoing IVF: a meta-analysis of randomized controlled trials.

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Testosterone therapy for women with poor ovarian response undergoing IVF: a meta-analysis of randomized controlled trials.

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