IVF Treatment Clinical Trial
— AMJHOfficial title:
The Effect of Triggering on the Quantitative Assessment of Follicle Size on Oocyte Development
NCT number | NCT03660813 |
Other study ID # | 4689-17-SMC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | August 1, 2021 |
Verified date | June 2022 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Studies have shown that the follicles greater in diameter was most likely to have a mature oocyte that was capable of fertilization and best suited for development into a high-quality embryo. Smaller follicles showed lower rates ( 60%). Lately new triggering protocols have emerged aiming to improve the proportion of mature oocytes at the time of retrieval. The aim of this study is to learn the effects of the dual triggering compared to the standard hCG triggering on the oocyte development and quality as a function of the follicle size
Status | Completed |
Enrollment | 200 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Age- 18-45 2. Antagonist protocol 3. Triggering: A- with Ovitrelle ( HCG) 250 mcg B- with dual triggering - Ovitrelle ( HCG) 250 mcg + Decapeptyl ( GnRH Agonist ) 0.1 mg*2 Exclusion Criteria: 1. Endometriosis 2. Known mutation of Fragile X |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Andersen CY. Characteristics of human follicular fluid associated with successful conception after in vitro fertilization. J Clin Endocrinol Metab. 1993 Nov;77(5):1227-34. — View Citation
Bergh C, Broden H, Lundin K, Hamberger L. Comparison of fertilization, cleavage and pregnancy rates of oocytes from large and small follicles. Hum Reprod. 1998 Jul;13(7):1912-5. — View Citation
Miller KF, Goldberg JM, Falcone T. Follicle size and implantation of embryos from in vitro fertilization. Obstet Gynecol. 1996 Oct;88(4 Pt 1):583-6. — View Citation
Orvieto R. Triggering final follicular maturation-hCG, GnRH-agonist or both, when and to whom? J Assist Reprod Genet. 2016 Oct;33(10):1415-1416. Epub 2016 Jul 22. — View Citation
Rosen MP, Shen S, Dobson AT, Rinaudo PF, McCulloch CE, Cedars MI. A quantitative assessment of follicle size on oocyte developmental competence. Fertil Steril. 2008 Sep;90(3):684-90. doi: 10.1016/j.fertnstert.2007.02.011. Epub 2008 Feb 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oocyte retrieved in each of the follicular size groups | Number of oocyte retrieved in each of the follicular groups divided according to the maximal dimensional size | Through study completion, an average of 1 year | |
Secondary | Metaphase II oocytes (MII) | Oocyte undergone nuclear maturation -Metaphase II oocytes (MII) | Through study completion, an average of 1 year | |
Secondary | Fertilization rate | Fertilization rate ( 2 pronuclear) | Through study completion, an average of 1 year | |
Secondary | Top Quality Embryo | Top Quality Embryo - Day-3 embryo with 3-4 cells with of to 15% fragmentation rate | Through study completion, an average of 1 year |
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