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CTRI Number  CTRI/2024/08/072365 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Microbiota in patients with unexplained infertility and repeated implantation failure  
Scientific Title of Study   Characterization of the uterine microbiota from women with unexplained infertility and recurrent implantation failure planned for in-vitro-fertilization (IVF)- a pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neena Malhotra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences
Room NO 3064 B 3rd Floor Teaching Block AIIMS New Delhi
South
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Neena Malhotra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences
Room NO 3064 B 3rd Floor Teaching Block AIIMS New Delhi
South
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Neena Malhotra 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences  
Address  All India Institute of Medical Sciences
Room NO 3064 B 3rd Floor Teaching Block AIIMS New Delhi
South
DELHI
110029
India 
Phone  9891557707  
Fax    
Email  malhotraneena@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029, 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 
Neena Malhotra  All India Institute of Medical Sciences New Delhi  Deptt of Obs and Gynae, All India Institute of Medical Sciences Ansari Nagar
South
DELHI 		 01126593361

malhotraneena@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Group1 Inclusion (Fertile controls)
i. Healthy oocyte donors aged 20-35 years
ii. Willing to participate in the study
Group 2 (Unexplained Infertility)
Women age 20-35 years and willing to participate in the study
Group 3 ( Recurrent implantation failure )
i. Women undergoing 2 failed fresh or frozen transfer of good quality embryos
ii. Women aged 20-36 years
iii. Willing to participate in the study
 
 
ExclusionCriteria 
Details  Group 1 (Fertile controls)
i. On any hormone therapy including oral contraceptive
ii. On recent use of antibiotics or probiotic therapy
iii. With immune disorders including SLE, Rheumatoid arthritis
Group 2 ( Unexplained infertility)
i. On any hormone therapy including oral contraceptive
ii. On recent use of antibiotics or probiotic therapy
iii. Severe male factor infertility
iv. Endometriosis in female
v. Tubal factor and or presence of hydrosalpinges on HSG/ USG
vi. Endometrial TB
vii. Sub-mucous fibroids or polyp
Group 3 ( Recurrent implantation failure)
i. On any hormone therapy including oral contraceptive
ii. On recent use of antibiotics or probiotic therapy
iii. Women with endometriosis, tubal factor infertility
iv. Endometrial TB
v. Sub-mucous fibroids or polyp
vi. Uterine adenomyosis
vii. Unwilling to participate in study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation
• To compare the endometrial microbiota in women with RIF and unexplained infertility with microbiota from fertile age matched women during the window of implantation.
 		 Baseline sample only  
 
Secondary Outcome  
Outcome  TimePoints 
To characterize the microbiota from endometrial fluid samples in fertile Indian women during the widow of implantation
• To compare the endometrial microbiota in women with RIF and unexplained infertility with microbiota from fertile age matched women during the window of implantation.
 		 0-12 months Recruitment of subjects
3-10 months Collection of endometrial samples and transport for metagenomic analysis
9-12 months Analysis and interpretation of results
 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   30/08/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Infertilty affects almost 10 percent of the population with 30 percent cases being unexplained where despite doing a battery of investigations no cause is identified. While the quality of embryo can be ensured by techniques like Preimplantation Genetic testing, the quality of endometrium is a big challenge. The process of implantation is an immune mediated process with upregulation and downregulation of various mediators and receptors. Bacteria is known to affect immunity. Human microbiome Project has mapped the microbiota of various body sites including vagina. But the upper reproductive tract is not extensively studied. The concept of sterile womb is outdated as recent data suggests presence of commensals in endometrium. As the gut microbiota regulates immunity, extrapolating the same finding to endometrium compels us to study the role of uterine microbiota in immunity further affecting implantation. The present study aims to define the natural microbiota of fertile Indian females and compare it with infertile females and females with recurrent implantation failure. This will further help in unravelling this mysterious entity of recurrent implantation failure which despite immunotherapies fails to provide successful results.  
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