跳至主要内容
临床试验/CTRI/2021/01/030383
CTRI/2021/01/030383尚未招募不适用

Predictive value of post trigger serum beta HCG levels with respect to occyte number and quality

Gunasheela Surgical and Maternity Hospital1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2021年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
123
试验地点
1
主要终点
The effects of higher dose beta HCG on BMI in women

研究概览

简要总结

Title: 

PROSPECTIVE STUDY ON  PREDICTIVE VALUE OF POST TRIGGERSERUM BETA HCG LEVELS WITH RESPECT TO OOCYTE NUMBER AND QUALITY

AIMS AND OBJECTIVES:

Primary objective:

To study the correlation between post trigger serum beta HCG levels andOptimum follicle to oocyte rate

Secondary objectives:

  1. To study correlation between Serum Beta HCG levels post trigger andmature oocyte rates.
  2. To find correlation between BMI and post trigger Serum beta HCG values.

BACKGROUND:

Human chorionicgonadotropin (HCG) injection is widely used as a surrogate for luteinizinghormone (LH) during in vitro fertilization (IVF) cycles, in which itsadministration induces oocyte (egg) maturation, loosening of egg from itssurrounding and egg release cumulus complex and ovulation. Humanchorionic gonadotropin (HCG) mimics the mid-cycle LH surge. It is clear that the ovulatoryinjection of HCG is required to assure that oocytes will be retrieved at timeof retrieval, thus avoiding “empty follicle syndrome.†(no eggs obtained)  In our practice, we have patients returningthe morning after administering 250microgram of recombinant HCG so that we mayassess their serum beta HCG level and to help determine if the patientscorrectly administered the injection and if serum beta HCG levels are less than45mIU they are given a re-trigger to prevent no eggs retrieval at egg pick up .

Although it is clear that some level of serumbeta HCG after the ovulatory injection is necessary for oocyte retrieval, it isnot clear whether a specific threshold level of serum beta HCG is required tomaximize the optimum follicle to oocyte ratio.

Some studies haveindicated that the serum Beta HCG level after HCG injection is related toclinical pregnancy rate, number of retrieved oocytes and metaphase II(MII)rate, but there has been considerable debate about it. Thedeleterious effects of obesity on female reproduction are well recognized andhave resulted in a large proportion of obese women seeking treatment forinfertility. Hence, we chose to examine if thepatient’s BMI has an affect on circulating serum beta HCG levels and outcomes.

METHODS

The data will berecorded in the study specific proforma

 couples will be screened for inclusion andexclusion criteria, the following information will be collected and entered inthe proforma from the eligible couple

  • ·        Informed consent
  • ·        Record of – BMI, AMH, AFC
  • ·        Indication for IVF
  • ·        Protocol planned – Antagonist Protocol

Observation period :All the eligible patients included in the study were asked to come on day 2/3of their menstrual cycle for start of IVF stimulation as per fixed antagonistprotocol with gonadotropin injections started as per patient age, AMH, AFC andBMI. Regular follicular monitoring scans were done from 6th day ofIVF stimulation to note the response and accessibility of both the ovaries.Patient is planned for HCG trigger, When ≥ 3 follicles of ≥17mm are seen onscan., and OPU will be scheduled 35hrs post administration of HCG trigger.Following administration of Recombinant HCG 250mcg, they are asked to come forblood test 12hrs latter to estimate the serum beta HCG values.Visit 2

Review of Serum Beta HCG values 12 hrs posttrigger , If serum beta HCG < 45mIU the patient will receive re-trigger withGnRH agonist and OPU will be scheduled at 34.5hrs post trigge

  • Pro-formareview and following data will be updated in the same.
  • OptimumFollicle to oocyte ratio
  • Mature oocyte rate

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 38.00 Year(s)(—)
性别
Female

入选标准

  • Women undergoing IVF treatment at Gunasheela Surgical and Maternity Hospital 2)Both ovaries easily accessible during follicular scans 3) Antagonist protocol with HCG trigger.
  • Normal male factor.

排除标准

  • Donor cycles 2) Dual trigger/ GnRHa trigger 3) Poor ovarian reserve with AMH< 0.5 ng/dl.

结局指标

主要结局

The effects of higher dose beta HCG on BMI in women

时间窗: After each IVF cycle (21 days)

次要结局

  • The effects of higher dose beta HCG on oocyte quality in women(day 2,5,12,21)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

Loading locations...

相似试验

Predictive value of serum beta HCG levels with... | 临床试验