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临床试验/CTRI/2025/02/080584
CTRI/2025/02/080584已完成3 期

Comparing IVF Outcomes of Progestin Primed Ovarian stimulation(PPOS) with Ultrashort flare(USF)GnRH Agonist in Expected Poor responders(POSEIDON 3,4)-A Multicentric Randomised controlled Trail

Oasis Fertility Centre3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年2月24日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
220
试验地点
3
主要终点
Oocyte Retrieval Rate,Maturation rate ,Fertilization rate, ,blastulation rate .

研究概览

简要总结

Poor responders constitute approximately 47% of assisted reproductive technology (ART) patients. With the increasing delay in childbearing, POSEIDON group 4 seems to increase constituting more than 50% of the total POSEIDON population, whereas group 3 patients constitute approximately 10%(1). Inspite of various treatment options available, there are lack of good quality studies to suggest the stimulation protocol for better results in women with poor ovarian reserve .Also ,need for multiple stimulations for pooling up of embryos also make cost as concern. The recommendations from ESHRE regarding the use of PPOS for IVF stimulation are conditional, emphasizing the need for more robust and high-quality studies.However, limited data were available to compare the efficacy of PPOS and Ultrashort flare GnRH agonist protocol in expected poor responders.

There are previous studies comparing ppos with GnRH antagonist protocol retrospectively with no difference in CLBR  by Zhang et al in china (2)

But there were no randomised controlled trails in poseidon population comparing ppos with ultra short flare GnRH agonist protocol

so we need a Randomized controlled trial to investigate the potential of PPOS and USF GnRH agonist protocol used for the poor responders undergoing IVF/ICSI treatment to suggest better stimulation in terms of cost , compliance and IVF outcomes.

1.Conforti A, Esteves SC, Picarelli S, Iorio G, Rania E, Zullo F, et al. Novel approaches for diagnosis and management of low prognosis patients in assisted reproductive technology: the POSEIDON concept. Panminerva Med. (2019) 61:24–9. 10.23736/S0031-0808.18.03511-5 [DOI] [PubMed] [Google Scholar]

2.Zhang S, Yin Y, Li Q, Zhang C. Comparison of Cumulative Live Birth Rates Between GnRH-A and PPOS in Low-Prognosis Patients According to POSEIDON Criteria: A Cohort Study. Front Endocrinol (Lausanne). 2021 Jun 21;12:644456. doi: 10.3389/fendo.2021.644456. PMID: 34234739; PMCID: PMC8256850.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
21.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Expected Poor responders as defined by POSEIDON criteria (Groups 3-4).
  • Freeze all cycles.

排除标准

  • Women with any current or past diseases affecting ovaries Hypogonadotrophic hypogonadism Premature ovarian insufficiency.

结局指标

主要结局

Oocyte Retrieval Rate,Maturation rate ,Fertilization rate, ,blastulation rate .

时间窗: Till 1 year

次要结局

  • days of stimulation ,Total gonadotropin dosage ,cycle cancellation rate , Follicular output rate(FORT) ,Follicle to oocyte index(FOI ),Implantation rate (IR),Biochemical pregnancy(BPR),Clinical pregnancy rate (CPR),Miscarriage rate (MR),Multiple pregnancy rate (MPR) ,Utilization rate(From time of recruitment till three to four months)

研究者

发起方
Oasis Fertility Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

POOJITHA CH

OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD

研究点 (3)

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