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Methods of treating infertility

A technology of composition and blastocyst, applied in the field of assisted reproduction, can solve problems such as low live birth rate per cycle

Pending Publication Date: 2017-10-17
FERRING BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Along the same lines, La Marca et al., Fertility and Sterility O-169 (2012), reported that in predicted high responders (subjects with AMH ≥ 5.2 ng / ml), stimulation with HP-hMG The group stimulated with the rFSH group had significantly more oocytes obtained but a significantly lower live birth rate per cycle than the group stimulated with rFSH

Method used

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  • Methods of treating infertility
  • Methods of treating infertility
  • Methods of treating infertility

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131] Embodiment 1-retrospective analysis

[0132] A retrospective analysis of data collected in two randomized controlled clinical trials was performed to compare GnRH agonist protocols (Anckaert et al., Human Reproduction 27:1829-39 (2012)) or GnRH antagonist protocols (Arce et al. ., Fertility and Sterility, 99:1644-53 (2013)) Treatment outcomes in patients stimulated with HP-hMG or recombinant FSH.

[0133] 1. Research groups

[0134] The main inclusion criteria for the long-term agonist trials were those aged 21-37 years with major indications for IVF (eg, tubal factor infertility, unexplained infertility, or mild male infertility). )), FSH levels within normal limits (1-12 IU / L), BMI of 18-29, and regular menstrual cycles (presumed ovulation) of 21-35 days. The main inclusion criteria for antagonist trials were an initial diagnosis of infertility with unexplained infertility or mild male infertility aged 21-34 years, a FSH level of 1-12 IU / L, a BMI of 18-25, and Wo...

Embodiment 2

[0183] Example 2 - Prospective Clinical Trials

[0184] A randomized, assay-blinded phase IV clinical trial is planned in the US comparing HP-hMG and rFSH in cycles of GnRH antagonists with mandatory single-blastocyst transfer in a population of high responder subjects. The aim of this study was to demonstrate that HP-hMG is at least non-inferior to rFSH with regard to Ongoing Pregnancy Rate (OPR) among potentially high responders undergoing IVF / ICSI treatment. Based on serum AMH levels ≥ 5.0 ng / ml (eg ≥ 5.2 ng / ml) (measured by Beckmann-Coulter Gen 2 as described by Arce et al., Fertility and Sterility 99: 1644-53 (2013), using a single reference laboratory (ReproSource, Inc., Woburn, MA) using materials and reagents from the Beckman Coulter-DSL assay (Chaska, MN)), subjects were prospectively classified as potential high ovarian responders.

[0185] This Phase IV, randomized, open-label, assayer-blinded, parallel group, multicenter study will be conducted at approximately ...

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Abstract

The present invention relates to improved assisted reproductive technology using highly purified menotropin (HP-hMG) to stimulate follicle development in controlled ovarian stimulation, particularly in women at risk of a high ovarian response to controlled ovarian stimulation.

Description

field of invention [0001] The invention described herein relates to assisted reproductive technology. In particular, described herein are methods for the treatment of infertility, including methods of controlled ovarian stimulation, which may be particularly useful in women in a state of high ovarian response thereto. Background of the invention [0002] Assisted reproductive technology (ART) methods typically involve stimulating oocyte production, collecting eggs from a woman's ovaries, combining the eggs with sperm outside the body, and transferring them to the woman's uterus (either from an egg donor or another woman). The success of ART is hampered by maternal and perinatal risks associated with stimulating oogenesis, such as ovarian hyperstimulation syndrome (OHSS) and ectopic pregnancy. Other concerns raised by ART are the production of good quality embryos and euploid blastocysts to support continued pregnancy rates and live birth rates. [0003] Gonadotropins, such...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/24A61P15/08
CPCA61K38/24A61K45/06A61P15/08C12N5/0604C12N5/0609A61K2300/00A61P15/00G01N33/74A61B17/425
Inventor 霍安·卡洛斯·阿尔塞塞斯简·鲁曼
Owner FERRING BV
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