Association Of IVF/ICSI Outcome With FSH-AMH And FSH- LH Ratio In Poor Ovarian Reserve
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
Dr Divya Pandey
VMMC and Safdarjung Hospital
