| CTRI Number |
CTRI/2025/10/096015 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of probiotic supplement in unexplained infertility |
|
Scientific Title of Study
|
Impact of Probiotic supplementation on endometrial microbiome in unexplained infertility |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECHR-2025-69-105-R1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashima Atrey |
| Designation |
Postgraduate resident |
| Affiliation |
Guru teg Bahadur hospital Dilshad garden, shahdara Delhi |
| Address |
Post graduate resident at
OBSTETRICS AND GYNAECOLOGY DEPARTMENT
Guru tag Bahadur hospital
East
DELHI
110032
India |
| Phone |
8851330989 |
| Fax |
|
| Email |
Atrey.aashima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. RICHA SHARMA |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
Guru teg Bahadur hospital Dilshad garden, shahdara Delhi |
| Address |
Director professor
Obstetrics and Gynaecology department
Guru teg Bahadur hospital
East
DELHI
110032
India |
| Phone |
8851330989 |
| Fax |
|
| Email |
risharma@ucms.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR BHANUPRIYA |
| Designation |
Postgraduate resident |
| Affiliation |
Guru teg Bahadur hospital Dilshad garden, shahdara Delhi |
| Address |
Professor
Obstetrics and gynaecology department
Guru teg Bahadur hospital delhi
East
DELHI
110032
India |
| Phone |
8851330989 |
| Fax |
|
| Email |
drpriyabhanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru teg Bahadur hospital Shahdara delhi |
|
|
Primary Sponsor
|
| Name |
Aashima Atrey |
| Address |
Post graduate resident
Obstetrics and gynaecology department
Guru teg Bahadur hospital Delhi 110095
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aashima Atrey |
Guru teg Bahadur hospital |
Department of obstetrics and gynaecology
Guru teg Bahadur hospital
Dilshad garden Delhi 110095
East
DELHI |
8851330989
atrey.aashima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHRUCMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
For 3 months |
| Intervention |
Probiotic containing lactobacillus crispatus |
For 3 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Women with normal ovulating cycles, normal uterine cavity, and at least unilateral patent tube
Men with normal HSA |
|
| ExclusionCriteria |
| Details |
Couples with HIV hepatitis B, hepatitis and hepatitis C
Woman with PID
Couples with systemic disease like diabetes, hypertension and tuberculosis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of woman with lactobacillus crispatus dominant endometrium versus non-dominant endometrium before and after 3 months of probiotic/placebo supplementation |
The proportion of woman with lactobacillus crispatus dominant endometrium versus non-dominant endometrium before and after 3 months of probiotic/placebo supplementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The number of women with positive UPT after a missed period in each group
2. Number of women with confirmed card activity 6 to 7 weeks of gestation in each group. |
|
|
|
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
|
N/A |
|
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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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 - NO
|
|
Brief Summary
|
Rationale Unexplained infertility, accounting for nearly 15-30% of infertility cases, lacks an identifiable cause despite normal routine investigations. Emerging evidence highlights the role of the endometrial microbiome, particularly the predominance of Lactobacillus crispatus, in successful implantation and pregnancy. Dysbiosis, characterized by a reduction in Lactobacillus dominance, is associated with poor reproductive outcomes. Probiotic supplementation, especially oral probiotics containing L. crispatus, has shown promise in restoring microbial balance and potentially improving pregnancy outcomes. However, research evaluating its direct impact on the endometrial microbiome in unexplained infertility remains limited. This study aims to bridge that gap by investigating whether probiotic supplementation can favourably modify the endometrial microbial environment and enhance fertility outcomes. The Mechanism of Action - Orally administered probiotics (Lactobacillus crispatus) migrate from intestine to the anus and finally to the vagina. This mechanism seems to combine mucosa-adhesive features of Lactobacilli and chemotactic factors that guide their migration towards the vaginal mucosa (Reid, 2008; Borges et al, 2014). Orally consumed probiotics have shown beneficial effects in studies investigating Bacterial Vaginosis (reduced U gent score) and Bacterial Vaginosis associated symptoms in comparison to both placebo and conventional antibiotic treatment and prolonged remission in recurrent BV as adjunct to conventional antibiotic therapy. Vaginal colonization by orally consumed probiotics has been reported both with strain-leve detection and as elevation of the supplemented species. Commensal bacterial in vagina represents one of the first lines of defence against vaginal infection. Lactobacillus crispatus play important roles in this defence, thus regulating the vaginal immune system. In the vaginal tract probiotics are considered to promote antimicrobial activity by reducing vaginal pay via lactic acid production, producing bacteriocins |