| CTRI Number |
CTRI/2025/06/089894 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to know the effect of various obesity parameters on IVF outcomes. |
|
Scientific Title of Study
|
Correlation of BMI, percentage body fat, serum and follicular fluid leptin levels with IVF parameters and pregnancy outcomes: A prospective cohort 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 |
Dr Aishwarya Pandya |
| Designation |
Junior Consultant and fertility specialist |
| Affiliation |
Oasis Fertility |
| Address |
Fourth floor, emerald one, windward business park, jetalpur road, Vadodara
Vadodara
GUJARAT
390020
India |
| Phone |
9723452230 |
| Fax |
|
| Email |
quality@oasisindia.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishwarya Pandya |
| Designation |
Junior Consultant and fertility specialist |
| Affiliation |
Oasis Fertility |
| Address |
Fourth floor, emerald one, windward business park, jetalpur road, Vadodara
GUJARAT
390020
India |
| Phone |
9723452230 |
| Fax |
|
| Email |
quality@oasisindia.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Pandya |
| Designation |
Junior Consultant and fertility specialist |
| Affiliation |
Oasis Fertility |
| Address |
Fourth floor, emerald one, windward business park, jetalpur road, Vadodara
GUJARAT
390020
India |
| Phone |
9723452230 |
| Fax |
|
| Email |
quality@oasisindia.in |
|
|
Source of Monetary or Material Support
|
| Oasis fertility- Fourth floor, emerald one, windward business park, jetalpur road, Vadodara-390020 |
|
|
Primary Sponsor
|
| Name |
Dr. Aishwarya Pandya |
| Address |
Oasis Fertility- Fourth floor, emerald one, windward business park, jetalpur road, Vadodara-390020 |
| 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 Aishwarya Pandya |
Oasis Fertility |
Fourth floor, emerald one, windward business park, jetalpur road, Vadodara
Vadodara
GUJARAT |
9723452230
quality@oasisindia.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Oasis Ethics Committee |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
All women undergoing IVF-ICSI-FET between the age of 21 to 37 years |
|
| ExclusionCriteria |
| Details |
1. Donor cycles
2. Couple with male factor infertility.
3. PGT-A cycles
4. Women with history of previous chemotherapy/radiotherapy and previous oophorectomy.
5. Male partner obesity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Live Birth Rate |
Every 4 weeks after recruitment of the participants begins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Implantation Rate |
Every 4 weeks after recruitment of participants begins |
| Miscarriage Rate |
Every 4 weeks after recruitment of the participants begins |
| Mean duration of stimulation |
Every 4 weeks after recruitment of participants begins |
| Mean dose of gonadotrophin |
Every 4 weeks after recruitment of participants begins |
| Percentage mature oocytes retrieved |
Every 4 weeks after recruitment of participants begins |
| Blastocyst formation rate |
Every 4 weeks after recruitment of participants begins |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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)
|
01/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a observational, prospective
cohort study to determine the effect of BMI(Body Mass Index), percentage body fat and
serum and follicular fluid leptin levels on ART(Assisted reproductive
technology) and reproductive outcomes of female patients undergoing IVF. This
study is conducted at Oasis fertility, Vadodara,Gujarat and will include a total of
98 female patients undergoing IVF. The primary outcome measure is live birth
rate. The secondary outcomes are implantation rate, miscarriage rate, mean
duration of stimulation, mean dose of gonadotrophins, percentage mature oocyte retrieved
and blastocyst formation rate. |