| CTRI Number |
CTRI/2024/10/075239 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effectiveness between human menopausal gonadotropin drug and recombianant(genetically engineered) drug by assessing the oocyte quality in women undergoing in vitro fertilisation
|
|
Scientific Title of Study
|
Comparing treatment efficacy between recombinant FSH LH and recombinant FSH Highly purified
human menopausal gonadotropins(HMG) A Prospective randomized controlled 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 |
Archana S |
| Designation |
Fertility Consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room No :2, Reproductive Medicine and endocrinology
A4 Hospital and Fertility centre Room No:2, 87 Arcot road ,
virugambakkam
Chennai
Room No:2, Reproductive Medicine and endocrinology
87 Arcot road ,
virugambakkam
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9840861267 |
| Fax |
|
| Email |
drarchana@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana S |
| Designation |
Fertility Consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room No :2, Reproductive Medicine and endocrinology
A4 Hospital and Fertility centre Room No:2, 87 Arcot road ,
virugambakkam
Chennai
Room No :2, Reproductive Medicine and endocrinology
A4 Hospital and Fertility centre Room No:2, 87 Arcot road ,
virugambakkam
Chennai
TAMIL NADU
600092
India |
| Phone |
9840861267 |
| Fax |
|
| Email |
drarchana@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana S |
| Designation |
Fertility Consultant |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Room No :2, Reproductive Medicine and endocrinology
A4 Hospital and Fertility centre Room No:2, 87 Arcot road ,
virugambakkam
Chennai
Room No :2, Reproductive Medicine and endocrinology
A4 Hospital and Fertility centre Room No:2, 87 Arcot road ,
virugambakkam
Chennai
TAMIL NADU
600092
India |
| Phone |
9840861267 |
| Fax |
|
| Email |
drarchana@a4fertility.com |
|
|
Source of Monetary or Material Support
|
| A4 Hospital and Fertility centre No 87 Arcot road virugambakkam chennai 600092 |
|
|
Primary Sponsor
|
| Name |
Archana S |
| Address |
A4 Hospital and Fertility centre Department of Reproductive medicine and Endocrinology
No 87 Arcot road virugambakkam chennai 600092 |
| 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 ARCHANA S |
A4 Hospital and Fertility centre |
Room No :2, Department of Reproductive Medicine and endocrinology
A4 Hospital and Fertility centre Room No:2, 87 Arcot road ,
virugambakkam
Chennai
Chennai
TAMIL NADU |
9840861267
drarchana@a4fertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
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 |
Giving rFSH and rLH for ovarian
stimulation |
Inj pergoveris and Inj gonal - f is given to subfertile patients undergoing stimulation for a duration of 10-11 days via subcutaneous route of administration.
The dose of the drug depends
on individual parameters (varies
from 150- 300 units) |
| Comparator Agent |
RFsh along with Human
menopausal gonadotropins for
ovarian stimulation |
Inj HMG and Inj gonal - f is
given to subfertile patients
undergoing stimulation for a duration of 10-11 days via subcutaneous and intramuscular route of administration.
The dose of the drug depends
on individual parameters (varies
from 150- 300 units) |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
BMI 18-35 kg/m 2
Unexplained subfertility
Male Factor subfertility |
|
| ExclusionCriteria |
| Details |
Oocyte donor patients
Congenital uterine anomalies uncorrected septum
Patient with endometriosis grade3&4
SOAT, Necrozoospermia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of oocytes assessed on the day of oocyte pick up |
Following 10-11 days of stimulation, once the follicle reaches more than 18 mm, trigger injection is given to induce ovualtion and maturation of follicles. oocyte pickup done 35 hours after trigger injection. after oocyte pickup, following denudation quality of oocytesis assessed on the same day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oocyte maturity rate, ICSI normal fertilization
rate, Blastocyst development rate, Clinical Pregnancy
rate |
Oocyte maturity rate- on the same day as oocyte
pick up day, ICSI normal fertilization rate- one
day post pickup,
Blastocyst development rate- day 5 after oocyte
pickup, Clinical Pregnancy rate 4 weeks after
embryo transfer. |
|
|
Target Sample Size
|
Total Sample Size="390"
Sample Size from India="390"
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)
|
15/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
HMG injeections and recombinant injections are used in the process of invitro fertilisation. in our study we strive to study whether giving a combination of recombinant FSH and recombinant LH improves the quality of oocytes and improves clinical pregnancy rate. To validate the paramount significance of rLH in influencing key aspects such as follicular development, oocyte and embryo quality, pregnancy and implantation rates |