| CTRI Number |
CTRI/2025/06/088580 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Ovarian rejuvenation therapy for infertile women with poor ovarian reserve |
|
Scientific Title of Study
|
Autologous Stem Cell Ovarian RejuvEnation (A-SCORE) Therapy for Infertile women with Poor Ovarian Reserve: an open-label prospective clinical trial. |
| Trial Acronym |
A-SCORE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Pandey |
| Designation |
Professor , OBS and Gyn. |
| Affiliation |
Vardhman Mahavir Medical College and SafdarJung hsptl |
| Address |
IVF Centre,Department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and SafdarJung hospital,MG Marg,DELHI
Vardhman Mahavir Medical College and SafdarJung hospital,MG Marg,DELHI
South West
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Pandey |
| Designation |
Professor , OBS and Gyn. |
| Affiliation |
Vardhman Mahavir Medical College and SafdarJung hsptl |
| Address |
IVF Centre,Department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and SafdarJung hospital,MG Marg,DELHI
Department of Obsterics and Gynaecology,Vardhman Mahavir Medical College and SafdarJung hospital,MG Marg,DELHI
South West
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Pandey |
| Designation |
Professor , OBS and Gyn. |
| Affiliation |
Vardhman Mahavir Medical College and SafdarJung hsptl |
| Address |
IVF Centre,Department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and SafdarJung hospital,MG Marg,DELHI
Department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and SafdarJung hospital,MG Marg,DELHI
South West
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research,Ansari Nagar,Delhi-110029,India |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital,MG Marg,Delhi-110029,India |
| Type of Sponsor |
Government medical college |
|
|
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 Divya Pandey |
Vardhman Mahavir Medical College and Safdarjung hospital |
IVF Centre,Department of Obstetrics and Gynaecology,Vardhman Mahavir Medical College and Safdarjung hospital,MG Marg,DELHI-110029,India.
South West
DELHI |
08860198440
dr_devya1@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N978||Female infertility of other origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
autologous bone marrow-derived stem cell intra-ovarian instillation followed by IVF cycle |
autologous bone marrow derived stem cell intra-ovarian instillation will be done once followed by IVF cycle after atleast 3 months |
| Intervention |
autologous platelet rich plasma intra-ovarian instillation followed by IVF cycle |
autologous platelet rich plasma intra-ovarian instillation will be done once followed by IVF cycle after atleast 3 months |
| Comparator Agent |
IVF cycle without prior intervention |
IVF cycle without prior intervention |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women with
Serum AMH (Anti Mullerian Hormone less than 1.2ng per ml (in the absence of oral contraceptive and sex steroid intake) AFC (Antral Follicle Count) less than 5 (in the absence of oral contraceptive and sex steroid intake)
POSEIDON group 3 and 4(Expected poor responders)
Hb more than 11 gm percent and platelets more than 1.5 lakhs
normal karyotype
presence of at least one ovary
normal thyroid function and prolactin
Normal Body Mass Index (18.5 to 24.9 kg per metre square
Normal serum Vitamin D and B12 level.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
· Refusal /Inability to give informed consent
· Any illness that precludes the use of anesthesia
· Sonographically unapproachable ovaries.
· POSEIDON 1 and 2 group (unexpected poor responders)
· Post chemotherapy or radiotherapy
· Any genetic or chromosomal disorder/abnormal karyotype
· Pregnant/breastfeeding women
· history of previous ovarian surgery,
· known clinical/biochemical hyperandrogenism or PCOS.
· History of autoimmune disorder
· history of symptoms of platelet dysfunction such as easy bruisability, frequent nose-bleeds, heavy menstrual bleeding, bleeding gums or excessive bleeding during dental procedures, bleeding disorder,
· blood-borne diseases like Hepatitis B, Hepatitis C, Syphilis, HIV,
· History of or evidence of any gynecologic malignancy,
· medical co-morbidity like heart disease, renal, pulmonary, liver, cerebrovascular disease, Diabetes mellitus, anemia, Deep venous thrombosis, coagulation disorder etc.
· History of current or recent drug intake (within last 12 weeks) (steroids, estrogens, progesterone, oral contraceptive pill, anticoagulant, NSAIDS, any other supplement with possible hormonal effect,
· Mullerian abnormality or any anatomical uterine disorder,
· Ashermann Syndrome,
· Endometriosis,
· active vaginal/cervix infection, any significant co-morbidity/ psychiatric disorder which compromises or interferes with consent giving/study participation/ follow up or interpretation of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Antral Follicle Count
Serum AMH level (Anti Mullerian Hormone) (ng/ml)
Serum FSH level (Follicle stimulating hormone) (mIU /ml)
|
Baseline,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in menstrual pattern
|
3 months |
Number of MII oocytes retrieved, Fertilisation rate,
Blastocyst formation rate
|
6 months |
Change in the level of IL-6,IL-11,TGF-beta,VEGF,IGF-1
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/07/2025 |
| 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="3"
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
|
The management and treatment of women with poor ovarian reserve (POR) is a challenging clinical situation with prevalence estimated to be between 9 and 24%. Importantly, egg quantity and quality seem to be compromised in this POR population. The aged oocytes tend to give rise to errors in cell division, leading to higher rates of aneuploidy and congenital malformations. The remedy to resultant infertility is either in-vitro fertilization (IVF) treatment with donor oocyte or adoption. Off-late attempts to rejuvenate ovarian function are being made and are under investigation to avoid these events. The use of Autologous Bone Marrow-derived Mononuclear Stem Cells (ABMMSC) is one such modality, which might prove promising in these cases. Bone marrow-derived mononuclear cells (MNCs) form a promising option of cell therapy for regenerative medicine because they can be rapidly isolated from patients after a bone marrow aspiration, do not require culture, and therefore permit autologous applications.Autologous platelet-rich plasma is another modality in this regard. The available data on efficacy is mainly available from some preclinical studies and a few observational clinical studies. With this background, this study is being proposed to explore the efficacy of autologous bone marrow-derived stem cells for the rejuvenation of ovaries in females with POR in terms of restoration of ovarian function by improved folliculogenesis, steroidogenesis, menstrual function, and fertility status. This might provide a potential treatment option for infertile females with poor ovarian reserve (POR) by providing them with an opportunity for improvement in hormonal profile, symptomatic relief in menstrual symptoms and above all possibility to have their biological offspring. |