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Clinical trial

Intrauterine Infusion of Granulocyte Colony Stimulating Factor and Reproductive Outcomes in Infertile Women With History of Recurrent Implantation Failure

ID
Name
2464949
Description
Intrauterine infusion of granulocyte colony stimulating factor and reproductive outcomes in infertile women with history of recurrent implantation failure
Trial arms
Trial start
2019-09-01
Estimated PCD
2023-10-30
Trial end
2023-11-30
Status
Recruiting
Treatment
Granulocyte Colony-Stimulating Factor
Granulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation
Arms:
Intervention group
Other names:
filgrastim
placebo
mock test without injection of G-CSF
Arms:
Control group
Size
100
Primary endpoint
Clinical pregnancy rate
4 weeks after ET
Eligibility criteria
Inclusion Criteria: 1. Age group (18-38) 2. History of at least 2 previous IVF or ICSI trial failures with ET of at least 2 good quality embryos in each trial. 3. Endometrial cavity within normal anatomy as assessed with transvaginal ultrasound (TV-US) with or without hysteroscopy and HSG if needed. 4. Availability of good quality embryos (at least 2 grade A embryos) for ET in the investigated trial Exclusion Criteria: Any factor which may affect quality of embryos transferred or endometrial receptivity and embryo growth, like: 1. Severe male factor infertility 2. Poor ovarian reserve (according to ESHRE criteria) 1 3. Uterine anatomic factor (eg polyp, intramural fibroid, endometrial septum, intrauterine synechiae .. etc) as well as endometritis 4. Immunological disorder (eg: SLE, APS, ... etc) 5. Thyroid or adrenal dysfunction 6. Thrombophilia history or tendency as proven by labs in suspected women 7. Untreated hyperprolactinemia 8. Genetic abnormalities in the infertile couple 9. Chronic hematologic, renal or liver disease
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-08-31

1 organization

1 product

3 indications

Organization
Cairo University
Product
Granulocyte Colony-Stimulating Factor
Indication
Recurrent Implantation Failure
Indication
Granulocyte Colony-Stimulating Factor
Indication
infertility