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临床试验/CTRI/2025/08/092388
CTRI/2025/08/092388尚未招募不适用

Association Of IVF/ICSI Outcome With FSH-AMH And FSH- LH Ratio In Poor Ovarian Reserve

VMMC and Safdarjung hospitalDelhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Number of oocytes retrieved Fertilization rate

研究概览

简要总结

Background

The management of patients with poor ovarian response (POR) to exogenous gonadotropin stimulation is a challenging problem in in vitro fertilisation (IVF) cycles. The incidence of poor response to ovarian stimulation is estimated to be 9-24%. By identifying reliable, accessible hormonal predictors of IVF success in this subgroup, it is aimed to enhance clinical decision- making and enable more tailored stimulation protocols. This could ultimately improve pregnancy outcomes and provide better prognostic counselling for women with low ovarian reserve.

Based on this evidence collected from the available literature, the current study has been designed with the aim of studying association of IVF/ICSI outcome with FSH-AMH and FSH- LH ratio in poor ovarian reserve.

AIM-To study association of IVF/ICSI outcome with FSH-AMH and FSH-LH ratio in poor ovarian reserve.

OBJECTIVE: To determine the association of IVF/ICSI outcome with FSH-AMH and FSH- LH ratio in poor ovarian reserve.

**Study Design:**Prospective Observational Cohort Study

 Duration: 18 months

 Setting: IVF centre, Department of Obstetrics and Gynaecology & Department of Pathology, VMMC & Safdarjung Hospital, New Delhi.

Inclusion CriteriaWomen aged 21–42 years with infertility undergoing IVF/ICSI with Anti-müllerian hormone

< 1.2 ng/ml and or Antral follicle count <5

 Exclusion Criteria1.      Donor gamete cycles

 2.      PCOS

 3.      Severe male factor infertility

 4.      Uncontrolled hypothyroidism

 5.      Uncontrolled hyperprolactinemia

 After screening, enrollment will be done as per the eligibility criteria; informed consent will be taken. ART in this study will include IVF(in vitro fertilisation) and ICSI( intracytoplasmic sperm injection). Workup of the couple will be done as per the institutional protocol. Baseline parameters (FSH,LH, AMH) will be noted on day2/3, antral follicle count(AFC) will be assessd by transvaginal sonography on D2/D3 FSH-AMH and FSH-LH ratio will be calculated. Data will be collected as per the proforma. All women will undergo a standardised ovarian stimulation protocol with tablet letrozole 5mg/day on day 2- 6, along with gonadotropin

(FSH/HMG) 150-225 IU/day from day2/3 onwards. The trigger for ovulation will be given injection hCG when the follicle size is more than or equal to 18mm Oocyte pickup will be done 35-36 hours after the trigger. This will be followed by IVF/ICSI. Subsequently, embryo grading will be done.

Outcome will be noted in terms of

number of oocytes retrieved

Fertilization rate

embryo quality and cycle cancellation

rate

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 42.00 Year(s)(—)
性别
Female

入选标准

  • Women aged 21 to 42 years with infertility undergoing IVF/ICSI with Anti-müllerian hormone less than 1.2 ng/ml and,or Antral follicle count less than5.

排除标准

  • Donor gamete cycles
  • Severe male factor infertility
  • Uncontrolled hypothyroidism
  • Uncontrolled hyperprolactinemia.

结局指标

主要结局

Number of oocytes retrieved Fertilization rate

时间窗: BASELINE

Embryo quality

时间窗: BASELINE

Cycle cancellation rate

时间窗: BASELINE

次要结局

未报告次要终点

研究者

发起方
VMMC and Safdarjung hospitalDelhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Divya Pandey

VMMC and Safdarjung Hospital

研究点 (1)

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