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CTRI Number  CTRI/2025/09/095148 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Oral Antibiotics Alone versus Oral Plus Intrauterine Antibiotics for Improving Pregnancy Outcomes in Women with Chronic Endometritis after IVF Failure 
Scientific Title of Study   Role of intrauterine antibiotic infusion combined with oral antibiotic administration in improving pregnancy outcome in women with chronic endometritis diagnosed by CD138 test seeking care for failed IVF. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apoorva Dave 
Designation  Assistant Professor 
Affiliation  Department of Obstetrics and Gynecology, Datta Meghe Institute of Higher Education and Research 
Address  Doctors Quarters, AVBRH Campus, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha -442001, Maharashtra, India

Wardha
MAHARASHTRA
442001
India 
Phone  8348771113  
Fax    
Email  dr.apoorvadave@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepti Shrivastava 
Designation  Professor 
Affiliation  Department of Obstetrics and Gynecology, Datta Meghe Institute of Higher Education and Research 
Address  Doctors Quarters, AVBRH Campus, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha -442001, Maharashtra, India

Wardha
MAHARASHTRA
442001
India 
Phone  9860817801  
Fax    
Email  deepti_shrivastav69@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Apoorva Dave 
Designation  Assistant Professor 
Affiliation  Department of Obstetrics and Gynecology, Datta Meghe Institute of Higher Education and Research 
Address  Doctors Quarters, AVBRH Campus, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha -442001, Maharashtra, India

Wardha
MAHARASHTRA
442001
India 
Phone  8348771113  
Fax    
Email  dr.apoorvadave@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha -442001, Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
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 Apoorva Dave  Acharya Vinoba Bhave Rural Hospital  Obstetrics and Gynaecology Department, Wardha Test Tube Baby Centre, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education & Research Sawangi(Meghe), Wardha
Wardha
MAHARASHTRA 		 08348771113

dr.apoorvadave@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, DMIHER(DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ciprofloxacin  200 mg/100 ml (3 ml infusion on every 3rd day) for 30 days  
Intervention  Doxycycline  100 mg BD for 14 Days 
Comparator Agent  Doxycycline  100 mg BD for 14 Days 
Intervention  Metronidazole  400 mg BD for 14 Days 
Comparator Agent  Metronidazole  400 mg BD for 14 Days 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  Positive diagnosis of Chronic endometriosis
Previous IVF Failure
Recurrent Pregnancy Loss (RPL) or Recurrent implantation Failure (RIF)
No previous live birth
FSH and LH levels evaluated on day 2 of menstrual cycle less than 12 IU/ml
AMH levels greater than 1.1 ng/ml
Progestrone levels evaluated on day 21 of menstrual cycle greater than 2 and less than 25 ng/ml
BMI greater than 18.5 and less than 29.9 
 
ExclusionCriteria 
Details  Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
Current or previous cancer diagnosis.
Auto-immune, genetic or reproductive disorders.
Reproductive history of pregnancy loss due to genetic abnormalities.
Male factor infertility diagnosis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Biochemical Pregnancy Rate (Beta HCG) and Clinical Pregnancy Rate (Gestational Sac and fetal heart sound on USG)  2-3 weeks after embryo transfer and 6-8 weeks post embryo transfer 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   01/11/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.apoorvadave@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a prospective, randomised controlled trial conducted at the Wardha Test Tube Baby Centre, AVBRH, DMIHER, India, evaluating the efficacy of oral antibiotic administration (OAA) alone versus combined intrauterine antibiotic infusion plus oral antibiotic administration (OAA+IAI) in women with CD138-confirmed chronic endometritis (CE) and at least one prior failed in-vitro fertilisation (IVF) cycle. The hypothesis is that combined intrauterine and oral antibiotic therapy will improve pregnancy outcomes compared to oral antibiotics alone. Forty women (20 per arm) were allocated to receive either OAA (doxycycline + metronidazole) for 14 days or OAA plus intrauterine ciprofloxacin infusions every 3 days for 30 days. The primary outcomes were biochemical and clinical pregnancy rates; secondary outcomes included implantation rate, miscarriage rate, and treatment tolerability. The study found no statistically significant differences in pregnancy outcomes between groups, suggesting that oral antibiotic therapy alone may be sufficient for CE management in IVF failure cases, particularly in resource-limited settings. 
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