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临床试验/NCT03204253
NCT03204253已完成不适用

Effects of Recombinant LH in Late Phase of Ovarian Stimulation in Patients With Repeated Implantation Failure, Clinical Results

University of Roma La Sapienza0 个研究点目标入组 60 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Number of ovocites retrived

研究概览

简要总结

Pregnancy rates fall dramatically in women after 35 years undergoing to IVF or ICSI. While ovarian aging obviously plays the major role in this phenomenon, over suppression of endogenous LH concentrations with GnRH agonists or antagonists-an integral part of standard IVF/ ICSI protocols-may also play a pivotal role.

Assisted reproduction technology protocols using GnRH agonists have been considered as the standard protocol during the last two decades, but the use of GnRH antagonists offers the opportunity to control the endogenous LH surge in a rapid and more convenient way.

LH plays a key role in the intermediate-late phases of folliculogenesis. The presence of receptors for LH in cumulus granulosa cells and its correlation with oocyte maturation has been demonstrated. Although ovarian stimulation is efficiently achieved in most cases by the administration of exogenous FSH alone, specific subgroups of women may benefit from LH activity supplementation during ovarian stimulation. Some authors have found improved outcome with LH activity supplementation in advanced reproductive age women.

LH has a number of roles in follicular development, induction of ovulation, completion of meiosis I, early luteinization and the production of progesterone.

The efficacy of recombinant human follicle-stimulating hormone (r-hFSH) for ovarian stimulation is well established however, the role of supplementary recombinant human luteinizing hormone (r-hLH) is less clear.

Aim of the present study is to evaluate If adding rLH in the late phase of stimulation can benefit in some patient awith repeated implantation failure.

详细描述

Study Design, Size and Duration

The study was conducted at the - Bio fertility IVF Center, Rome, Italy, on infertile couples due to male factor undergoing ICSI treatment.

The study was reviewed and approved by the institutional review board at the - Biofertilty IVF Center.

All patients undergoing ICSI and participating in the study gave informed consent.

Patients included in the study had regular spontaneous menstrual cycles (26-39 days) and were aged < 42 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Only patients with repeated implantation failure in at least two previous IVF cycles were included.

排除标准

  • Patients were excluded from the study if they had any clinically significant systemic disease, polycystic ovarian syndrome (PCOS), a previous history of severe ovarian hyperstimulation syndrome (OHSS), abnormal gynaecological bleeding of unknown origin, a previous history of intolerance to any of the agents used in the study.

研究组 & 干预措施

rFSH + r-LH in combination

Experimental

treatment group

干预措施: rFSH + r-LH in combination (Drug)

rFSH alone

Active Comparator

control group

干预措施: rFSH alone (Drug)

结局指标

主要结局

Number of ovocites retrived

时间窗: 1 cicle of stimulation of 14 days

Possible beneficial effects of rLH in the late phase of stimulation in patient with repeated implantation failure

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Francomano

PHD

University of Roma La Sapienza

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