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CTRI Number  CTRI/2014/12/005289 [Registered on: 15/12/2014] Trial Registered Retrospectively
Last Modified On: 17/12/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effects of two different protocols of cetrorelix injection timings in IUI cycles in infertile women 
Scientific Title of Study   To compare the efficacy of two different regimens of GnRH antagonists in clomiphene-Gonadotropin induced controlled ovulation and IUI cycles 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alka Kriplani 
Designation  Professor and Head of Department 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 3076 Office-Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, East Ansari nagar New Delhi

South
DELHI
110049
India 
Phone  011-26594933  
Fax    
Email  kriplanialka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Garima Kachhawa 
Designation  Assitant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  E-28, West Ansari nagar, Near All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  09868246702  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devendra siva karthikS 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences 
Address  E-28, West Ansari nagar, Near All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  09968872674  
Fax    
Email  karthiksds@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI  
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
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 
Prof Alka Kriplani  All India Institute of Medical Sciences  East Ansari nagar
South
DELHI 		 01126594933

kriplanialka@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  clomiphene-gonadotropin ovulation induction cycles with Cetrorelix  Cetrorelix as 0.25mg subcutaneously is the intervention drug studied in two different regimens given in clomiphene citrate + sequential human menopausal gonadotropin cycles - In Fixed regimen (Group I), cetrorelix is given from day 8 of menstrual cycle - In Flexible regimen (Group II), Cetrorelix is given from the day of 14 millimetre ovarian follicle. Human Menopausal gonadotropin and cetrorelix are continued -till the development of dominant follicle which is of 18 millimetre size or -till day 18 of cycle if there is no development of dominant follicle 
Comparator Agent  clomiphene-gonadotropin ovulation induction cycles without Cetrorelix  In control group (Group III), clomiphene citrate + sequential human menopausal gonadotropin regimen are only given with out cetrorelix. Human Menopausal gonadotropin is continued -till the development of dominant follicle which is of 18 millimetre size or -till day 18 of cycle if there is no development of dominant follicle 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  1)Unexplained infertility;
2)Mild male factor infertility;
3)Ovulation dysfunction infertility with previously failed induction with letrozole or clomiphene;
4)At least one patent fallopian tube;
5)BMI 18.5–29.9 kg/m2
6)Euthyroid state
7)No associated medical problems like diabetes mellitus or Hypertension or Drug allergies.
 
 
ExclusionCriteria 
Details  1)Severe male factor infertility;
2)Stage III or IV endometriosis;
3)Tubal Factor Infertility;
4)baseline FSH >12 IU/L;
5)Less than four antral follicles per ovary  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Premature luteinization rate
2.Ovulation rates  		 1. If LH more than 10 mIU/ml and Progesterone more than 2ng/ml on day 10 and/or day 12 of menstrual cycle
2. Documented by transvaginal ultrasound after 36 hours of ovulation trigger 
 
Secondary Outcome  
Outcome  TimePoints 
1.Pregnancy rate
2.Endometrial thickness
3.Adverse effects like ovarian hyperstimulation syndrome and multiple pregnancies
4.Cycle cancellation rate
 		 1.Positive urine pregnancy test after 15 days of IUI
2.Thickness measurement on the day of dominant follicle (more than or equal to 18 mm size)
3.Checked on the day of positive urine pregnancy test or in a symptomatic patient
4.If no dominant follicle by day 18 of the cycle 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, open label, parallel group, three-arm controlled clinical trial in which the efficacy of two different regimens of GnRH antagonist i.e., Cetrorelix, in fixed and flexible regimens, was evaluated in clomiphene - gonadotropin induced controlled ovulation and intrauterine insemination cycles at All India Institute of Medical Sciences, New Delhi. The primary outcomes were premature luteinization rate and ovulation rates. The secondary outcomes were pregnancy rates, effect on endometrial thickness, effect on hormonal profiles, cycle cancellation rates and adverse effects like OHSS and multiple pregnancies.

Dosages of drug –

  • Group I-Fixed day group (n =15 ) :  Clomiphene 50 mg/d orally will be given on day 2 to 6 of menstrual cycle  + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that +  Cetrorelix  0.25mg s/c from day 8 + hCG 10,000 IU (more than 18 mm  follicle) + IUI after 34-38 hours.
  • Group 2-Flexible day group (n= 15 ) :  Clomiphene 50mg/d orally will be given on day 2 to 6 of menstrual cycle  + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that + Cetrorelix 0.25mg s/c @ follicle size ≥ 14 mm or  if LH > 10 IU/L +  hCG 10,000 IU (more than 18 mm follicle) + IUI after 34-38 hours.
  • Group 3-control group (n=15 ) :  Clomiphene 50mg/d orally will be given on day 2 to 6 of menstrual cycle  + GMH 75 IU IM will be given daily in the same dose from day 6 to day 8 and dose increased according to response after that +  hCG 10,000 (more than 18 mm follicle) + IUI after 34-38 hours.

Duration of treatment – Maximum of three cycles per patient.

Investigation specifically related to projects- serum estradiol , serum LH, Serum progestrone



 
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