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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

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...

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Autores principales: Siristatidis, Charalampos, Stavros, Sofoklis, Dafopoulos, Konstantinos, Sergentanis, Theodoros, Domali, Ekaterini, Drakakis, Peter, Loutradis, Dimitrios
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275065/
https://www.ncbi.nlm.nih.gov/pubmed/34254280
http://dx.doi.org/10.1007/s43032-021-00683-3
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author Siristatidis, Charalampos
Stavros, Sofoklis
Dafopoulos, Konstantinos
Sergentanis, Theodoros
Domali, Ekaterini
Drakakis, Peter
Loutradis, Dimitrios
author_facet Siristatidis, Charalampos
Stavros, Sofoklis
Dafopoulos, Konstantinos
Sergentanis, Theodoros
Domali, Ekaterini
Drakakis, Peter
Loutradis, Dimitrios
author_sort Siristatidis, Charalampos
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43032-021-00683-3.
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spelling pubmed-82750652021-07-14 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 Siristatidis, Charalampos Stavros, Sofoklis Dafopoulos, Konstantinos Sergentanis, Theodoros Domali, Ekaterini Drakakis, Peter Loutradis, Dimitrios Reprod Sci Infertility: Clinical Trials 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43032-021-00683-3. Springer International Publishing 2021-07-12 /pmc/articles/PMC8275065/ /pubmed/34254280 http://dx.doi.org/10.1007/s43032-021-00683-3 Text en © Society for Reproductive Investigation 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Infertility: Clinical Trials
Siristatidis, Charalampos
Stavros, Sofoklis
Dafopoulos, Konstantinos
Sergentanis, Theodoros
Domali, Ekaterini
Drakakis, Peter
Loutradis, Dimitrios
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Infertility: Clinical Trials
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275065/
https://www.ncbi.nlm.nih.gov/pubmed/34254280
http://dx.doi.org/10.1007/s43032-021-00683-3
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