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Clinical Trials/CTRI/2025/08/092388
CTRI/2025/08/092388Not yet recruitingNot Applicable

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

VMMC and Safdarjung hospitalDelhi1 site in 1 country60 target enrollmentStarted: August 31, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Number of oocytes retrieved Fertilization rate

Study Overview

Brief Summary

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
21.00 Year(s) to 42.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of oocytes retrieved Fertilization rate

Time Frame: BASELINE

Embryo quality

Time Frame: BASELINE

Cycle cancellation rate

Time Frame: BASELINE

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
VMMC and Safdarjung hospitalDelhi
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Divya Pandey

VMMC and Safdarjung Hospital

Study Sites (1)

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