| CTRI Number |
CTRI/2024/04/065398 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of single versus double dose of recombinant human chorionic gonadotropin on final oocyte maturation in IVF cycles |
|
Scientific Title of Study
|
To compare the effect of single versus double dose of recombinant human chorionic gonadotropin on final oocyte maturation in long agonist in vitro fertilisation cycles- 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 |
Dr Aashim Garg |
| Designation |
MCh Senior Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Reproductive Medicine and Surgery, Amrita Institute of Medical Sciences
Ernakulam
KERALA
682041
India |
| Phone |
8860346840 |
| Fax |
|
| Email |
aashim.123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fessy Louis |
| Designation |
Professor and Head of Department |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Reproductive Medicine and Surgery, Amrita Institute of Medical Sciences
Ernakulam
KERALA
682041
India |
| Phone |
9846055224 |
| Fax |
|
| Email |
fessylouis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aashim Garg |
| Designation |
MCh Senior Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Reproductive Medicine and Surgery, Amrita Institute of Medical Sciences
Ernakulam
KERALA
682041
India |
| Phone |
8860346840 |
| Fax |
|
| Email |
aashim.123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aashim Garg |
Amrita Institute of Medical Sciences |
Department of Reproductive Medicine and Surgery, Amrita Institute of Medical Sciences
Ernakulam
KERALA |
08860346840
aashim.123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita 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 |
Double dose of recombinant human chorionic gonadotropin |
500mcg (250 x 2) of recombinant human chorionic gonadotropin injection stat dose |
| Comparator Agent |
Single dose of recombinant human chorionic gonadotropin |
250mcg of recombinant human chorionic gonadotropin injection stat dose (one injection only) |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All women between the age group of 21–40 years with normal or poor ovarian reserve undergoing IVF ET by Long Agonist Protocol. |
|
| ExclusionCriteria |
| Details |
History of OHSS
High basal ovarian reserve (AMH more than 8ng/ml or AFC more than 24)
Hyper response (more than 18 follicles of diameter 11mm or more) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of single versus double dose of recombinant human chorionic gonadotropin on total number of M-II oocytes retrieved per follicle. |
38 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of good quality embryos generated. |
4-5 days |
| Biochemical pregnancy rate |
2-3 weeks |
| Clinical pregnancy rate |
5-6 weeks |
| Incidence of OHSS |
7-10 days |
|
|
Target Sample Size
|
Total Sample Size="374"
Sample Size from India="374"
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)
|
22/04/2024 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Oocyte maturation is
a critical process to the success of in vitro fertilization (IVF)
treatment, during which the oocyte gains competence for fertilization. One of the most important predictive factors for the success of IVF is the
maturity of oocytes along with number and quality of oocytes available for
fertilization. In Long Agonist protocol, there is no endogenous hCG due to
suppression of Hypothalamic-Pituitary-Ovarian (HPO) axis. Since, final oocyte
maturation and quality of oocytes depend on exogenous hCG given, therefore, we
want to find the best dose of r-hCG for obtaining the highest number of mature
oocytes after stimulation. Women fulfilling the inclusion criteria will be included in the study and they will undergo treatment with standard long
gonadotropin‑releasing hormone (GnRH) agonist protocol. Patients will be randomly allocated into either the 250 or 500 µg r‑hCG
group according to a computer‑generated randomization. Transvaginal ultrasound‑guided oocyte retrieval will be performed 36
hours after administration of r‑hCG injection. Primary outcome includes total number of M-II oocytes retrieved per follicle and secondary outcomes include number of good quality embryos generated, biochemical pregnancy rate, clinical pregnancy rate, incidence of Ovarian
hyperstimulation syndrome (OHSS) and subgroup analysis in poor
responder group. |