CTRI/2021/10/037448
Completed
Phase 3
A Prospective, Open Label, Multi-Center Study To Evaluate The Safety And Efficacy Of Supplementation With Mulmina Amla Orange Health Drink In IVF Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Jagdale industries pvt Ltd
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •i.Age 21\-38 yrs
- •ii.BMI between 18\-32 kg/m2
- •iii.Basal FSH,LH,E2,Progesterone P4 and Prolactin levels within normal range on menstrual day 2
- •iv.Women with Normal or insignificant haematology and blood biochemistry done during screening visit
- •v.TVUS documenting presence of both ovaries without evidence of abnormality such as endometrioma \>5 cms ,presence of hydrosalpinx
- •vi.Husband or male partner or donor sperm with normal sperm motility and count ,or with Oligoasthenospermia
- •vii.Able to provide written informed consent for the study participation.
- •viii.If using fertility modifier supplements containing VitaminC,VitaminE,AminoAcid,Co\-Q,myoinositola one month washout period to be given before randomization.
Exclusion Criteria
- •I.Husband with Teratozoospermia with morphology less than 2 %
- •II. Stage 3\-4 endometriosis (ASRM classification)
- •III.hPoor ovarian less than 5Poseidon 3 and 4 category
- •IV.Any significant systemic disease or endocrine disorders like (Pituitary, Thyroid, Adrenal, Pancreas, Liver or Kidney) or any active condition requiring treatment which according to the investigator might interfere with the study.
- •V.Patients with severe uncontrolled diabetes mellitus.
- •VI.Untreated hyperprolactinemia.
- •VII.Abnormal bleeding of undetermined origin
- •VIII.Severe infections of reproductive tract like genital Tuberculosis and Sexually transmitted diseases.
- •IX.Known history of HIV/HbsAg/Hepatitis C.
- •X.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Safety and efficacy of donor T-lymphocytes depleted ex vivo of host alloreactive T-cells (ATIR) in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorEUCTR2012-004461-41-GBKiadis Pharma Netherlands B.V.30
Active, not recruiting
Phase 1
Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 19.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0 Level: PT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2015-002821-20-HRKiadis Pharma Netherlands B.V.20
Active, not recruiting
Phase 1
Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: PT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2015-002821-20-BEKiadis Pharma Netherlands B.V.20
Active, not recruiting
Phase 1
Safety and efficacy of donor T-lymphocytes depleted ex vivo of host alloreactive T-cells (ATIR) in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 19.1Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2012-004461-41-DEKiadis Pharma Netherlands B.V.30
Active, not recruiting
Phase 1
Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorEUCTR2015-002821-20-DEKiadis Pharma Netherlands B.V.20