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CTRI Number  CTRI/2021/01/030383 [Registered on: 11/01/2021] Trial Registered Prospectively
Last Modified On: 08/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Predictive value of serum beta HCG levels with occyte number and quality after artificially releasing an egg.  
Scientific Title of Study   Predictive value of post trigger serum beta HCG levels with respect to occyte number and quality  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aparna N 
Designation  Senior Consultant in Reproductive Medicine  
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  Department of Reproductive medicine, No 1 Dewan N. Madhava roa Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  080-4646260  
Fax    
Email  Aparna89n@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aparna N 
Designation  Senior Consultant in Reproductive Medicine  
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  Department of Reproductive medicine, No 1 Dewan N. Madhava roa Road, Basavanagudi


KARNATAKA
560004
India 
Phone  080-4646260  
Fax    
Email  Aparna89n@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lohith Chengappa Appaneravanda  
Designation  Research Associate in Reproductive Medicine  
Affiliation  Gunasheela Surgical and Maternity Hospital 
Address  Department of Reproductive medicine, No 1 Dewan N. Madhava roa Road, Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  080-4646260  
Fax    
Email  lohithwork123@gmail.com  
 
Source of Monetary or Material Support  
Gunasheela Surgical and Maternity Hospital  
 
Primary Sponsor  
Name  Gunasheela Surgical and Maternity Hospital 
Address  1, Dewan Madhava Rao Rd, Basavanagudi, Bengaluru, Karnataka 560004 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aparna N   Gunasheela Surgical and Maternity Hospital   Department of Reproductive Medicine. No. 1, Dewan N. Madhava Rao Road, Basavanagudi.
Bangalore
KARNATAKA 		 080-4646260

Aparna89n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Gunasheela Surgical and Maternity Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z68||Body mass index [BMI],  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  1)Women undergoing IVF treatment at Gunasheela Surgical and Maternity Hospital

2)Both ovaries easily accessible during follicular scans

3) Antagonist protocol with HCG trigger.

4)Normal male factor
 
 
ExclusionCriteria 
Details  1) Donor cycles
2) Dual trigger/ GnRHa trigger
3) Poor ovarian reserve with AMH< 0.5 ng/dl
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effects of higher dose beta HCG on BMI in women




 		 After each IVF cycle (21 days) 
 
Secondary Outcome  
Outcome  TimePoints 
The effects of higher dose beta HCG on oocyte quality in women   day 2,5,12,21 
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be Published in a Suitable Journal  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title: 
PROSPECTIVE STUDY ON  PREDICTIVE VALUE OF POST TRIGGER SERUM 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 and Optimum follicle to oocyte rate

 Secondary objectives:

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


BACKGROUND: 

Human chorionic gonadotropin (HCG) injection is widely used as a surrogate for luteinizing hormone (LH) during in vitro fertilization (IVF) cycles, in which its administration induces oocyte (egg) maturation, loosening of egg from its surrounding and egg release cumulus complex and ovulation. Human chorionic gonadotropin (HCG) mimics the mid-cycle LH surge. It is clear that the ovulatory injection of HCG is required to assure that oocytes will be retrieved at time of retrieval, thus avoiding “empty follicle syndrome.” (no eggs obtained)  In our practice, we have patients returning the morning after administering 250microgram of recombinant HCG so that we may assess their serum beta HCG level and to help determine if the patients correctly administered the injection and if serum beta HCG levels are less than 45mIU they are given a re-trigger to prevent no eggs retrieval at egg pick up .

 Although it is clear that some level of serum beta HCG after the ovulatory injection is necessary for oocyte retrieval, it is not clear whether a specific threshold level of serum beta HCG is required to maximize the optimum follicle to oocyte ratio.

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

METHODS

The data will be recorded in the study specific proforma

 

couples will be screened for inclusion and exclusion criteria, the following information will be collected and entered in the 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 2/3 of their menstrual cycle for start of IVF stimulation as per fixed antagonist protocol with gonadotropin injections started as per patient age, AMH, AFC and BMI. Regular follicular monitoring scans were done from 6th day of IVF stimulation to note the response and accessibility of both the ovaries. Patient is planned for HCG trigger, When ≥ 3 follicles of ≥17mm are seen on scan., and OPU will be scheduled 35hrs post administration of HCG trigger. Following administration of Recombinant HCG 250mcg, they are asked to come for blood test 12hrs latter to estimate the serum beta HCG values.

Visit 2

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

  •  Pro-forma review and following data will be updated in the same.
  •  Optimum Follicle to oocyte ratio
  • Mature oocyte rate


 

 
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