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A Randomized Controlled Trial on the Efficacy and Safety of Low-Dose hCG in a Short Protocol with GnRH Agonist and Ovarian Stimulation with Recombinant FSH (rFSH) During the Follicular Phase in Infertile Women Undergoing ART.

ABSTRACT: Τhis study aims to investigate whether the addition of low-dose hCG throughout stimulation in infertile women undergoing IVF improves IVF outcome parameters. This is a prospective, multicenter, randomized, double-blind, placebo-controlled, Phase IIIb clinical study, conducted in three university IVF units. We studied whether the addition of 100 IU hCG/day to a short GnRH agonist IVF protocol from the onset of the follicular phase (group 1, n=40) or placebo (group 2, n=41) had any impact on the number of high-quality transferred embryos at day 2 and clinical pregnancy rates. The comparison encompassed descriptive statistics, and univariate and multivariate analyses. Concerning the primary outcomes, we found no differences in both the number of high-quality embryos (≥2) at day 3 [21/40 (52.5%) vs. 14/41 (34.2%), p=0.095] and clinical pregnancy rates [10/40 (25%) vs. 10/41 (24.4%), p=0.949], respectively. Similarly, there were no differences concerning the secondary outcomes preset for this trial. According to the results of the multivariate logistic regression analysis, no significant associations were noted for primary outcomes (clinical pregnancy: adjusted OR=0.89, 95% CI: 0.29-2.75; (≥2 excellent quality embryos at day 3: adjusted OR=0.54, 95% CI: 0.21-1.42, with group 1 set as reference category); similarly, no differences were noted with respect to secondary outcomes, except from the increased odds of ≥2 poor-quality embryos at day 3 occurring in group 2 (adjusted OR= 11.69, 95%CI: 1.29-106.19). The addition of low-dose hCG to a short GnRH agonist protocol for IVF does not improve the number of top-quality embryos and clinical pregnancy rates.

SUBMITTER: Siristatidis C

PROVIDER: S-EPMC8275065 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundTraditionally, final follicular maturation is triggered by a single bolus of human chorionic gonadotropin (hCG). This acts as a surrogate to the naturally occurring luteinizing hormone (LH) surge to induce luteinization of the granulosa cells, resumption of meiosis and final oocyte maturation. More recently, a bolus of gonadotropin-releasing hormone (GnRH) agonist in combination with hCG (dual trigger) has been suggested as an alternative regimen to achieve final follicular maturation.MethodsThis study was a systematic review and meta-analysis of randomized trials evaluating the effect of dual trigger versus hCG trigger for follicular maturation on pregnancy outcomes in women undergoing in vitro fertilization (IVF). The primary outcome was the live birth rate (LBR) per started cycle.ResultsA total of 1048 participants were included in the analysis, with 519 in the dual trigger group and 529 in the hCG trigger group. Dual trigger treatment was associated with a significantly higher LBR per started cycle compared with the hCG trigger treatment (risk ratio (RR) = 1.37 [1.07, 1.76], I2 = 0%, moderate evidence). There was a trend towards an increase in both ongoing pregnancy rate (RR = 1.34 [0.96, 1.89], I2 = 0%, low evidence) and implantation rate (RR = 1.31 [0.90, 1.91], I2 = 76%, low evidence) with dual trigger treatment compared with hCG trigger treatment. Dual trigger treatment was associated with a significant increase in clinical pregnancy rate (RR = 1.29 [1.10, 1.52], I2 = 13%, low evidence), number of oocytes collected (mean difference (MD) = 1.52 [0.59, 2.46), I2 = 53%, low evidence), number of mature oocytes collected (MD = 1.01 [0.43, 1.58], I2 = 18%, low evidence), number of fertilized oocytes (MD = 0.73 [0.16, 1.30], I2 = 7%, low evidence) and significantly more usable embryos (MD = 0.90 [0.42, 1.38], I2 = 0%, low evidence).ConclusionDual trigger treatment with GnRH agonist and HCG is associated with an increased live birth rate compared with conventional hCG trigger.Trial registrationCRD42020204452 .

Project description:IntroductionPregnancy rates after frozen embryo transfer (FET) have improved in recent years and are now approaching or even exceeding those obtained after fresh embryo transfer. This is partly due to improved laboratory techniques, but may also be caused by a more physiological hormonal and endometrial environment in FET cycles. Furthermore, the risk of ovarian hyperstimulation syndrome is practically eliminated in segmentation cycles followed by FET and the use of natural cycles in FETs may be beneficial for the postimplantational conditions of fetal development. However, a freeze-all strategy is not yet implemented as standard care due to limitations of large randomised trials showing a benefit of such a strategy. Thus, there is a need to test the concept against standard care in a randomised controlled design. This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial.Methods and analysisMulticentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden. Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle. The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer.Ethics and disseminationThe study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committees in Denmark and Sweden. The results of the study will be publically disseminated.Trial registration numberNCT02746562; Pre-results.

Project description:BackgroundAcupuncture is widely used for infertile women without undergoing assisted reproductive techniques (ART) in China but its effect is unclear. We aim to assess whether acupuncture and its combined therapy exert a positive influence on the outcome of female fertility.MethodsWe searched 6 databases, including Medline, EMBASE, the Cochrane Central Register of Controlled Trials, the China National Knowledge Infrastructure (CNKI), the China Science and Technology Journal Database (VIP), and Wan-Fang Data, from inception to June 2018. Studies of randomized controlled trials (RCTs) on women with infertility treated by acupuncture or its combined therapy were included. A meta-analysis was performed using Revman 5.3. The methodological quality of the studies was assessed through the risk of bias assessment tool by the Cochrane Collaboration.ResultsThe pregnancy rate was significantly improved with treatment (RR = 1.84, 95% CI 1.62 to 2.10, P < .00001), compared to that in the control group. Subgroup analysis showed that comparing with pure western medicine intervention, no matter intervention with acupuncture alone, with acupuncture plus western medicine, with acupuncture plus Chinese medicine, or acupuncture plus Chinese medicine and western medicine, all of these subgroups exhibited significant improvement. The subgroup according to different types of infertility showed a significant improvement in infertility caused by polycystic ovary syndrome, tubal infertility, ovulatory disorder, and other factors. In addition, the ovulation rate and endometrial thickness were significantly increased. The level of LH was obviously decreased. Moreover, with acupuncture, less adverse effects occurred. The funnel plot revealed that publication bias might exist. All trials included had unclear risks in the aspects of allocation concealment, blinding of participants and personnel, blinding of outcome assessment, selective reporting, and other bias. Only 1 study was assessed as unclear risk in random sequence generation. In the incomplete outcome data, all studies were low risk, except 1.ConclusionsAcupuncture and its combined therapy may be effective for treating female infertility. However, the included studies are not robust enough to draw a firm conclusion due to the not robustly sampled quality of the included studies. Future high-quality RCTs are needed to confirm our findings.

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A Randomized Controlled Trial on the Efficacy and Safety of Low-Dose hCG in a Short Protocol with GnRH Agonist and Ovarian Stimulation with Recombinant FSH (rFSH) During the Follicular Phase in Infertile Women Undergoing ART.

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