IVF Clinical Trial
Official title:
Effect of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on Human in Vitro Oocyte Maturation (CAPA-IVM System) Success Rates in PCOS
Verified date | July 2021 |
Source | M? Ð?c Hospital |
Contact | Lan N Vuong, PhD |
Phone | +84903008889 |
drlan[@]yahoo.com.vn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In-vitro maturation (IVM) of human oocytes obtained from minimally stimulated or unstimulated ovaries offers a more "patient friendly" treatment option than the conventional Assisted Reproductive Technology (ART) treatment with controlled ovarian hyperstimulation (COH). However, maturation rate and the total blastocyst yield in oocytes undergoing in vitro maturation are still limited. This pilot study aims to evaluate the addition of an important growth factor known as Granulocyte macrophage colony stimulating factor (GM-CSF). The investigators hypothesize that the addition of GM-CSF to human IVM culture media will increase pregnancy rates to comparable levels to that of IVF, making it a viable clinical option for couples undergoing assisted reproductive treatment.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | March 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | Inclusion Criteria: - Diagnosed as PCOS using Rotterdam criteria (AFC=25 or the ovarian volume >10ml) - Agree to participate in the study Exclusion Criteria: - No major uterine or ovarian abnormalities - Endometriosis grade 2 or upper - Severe OAT (concentration <1 million/ml, motility <10%), surgical sperm |
Country | Name | City | State |
---|---|---|---|
Vietnam | My Duc Hospital | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
M? Ð?c Hospital |
Vietnam,
Guzman L, Adriaenssens T, Ortega-Hrepich C, Albuz FK, Mateizel I, Devroey P, De Vos M, Smitz J. Human antral follicles <6 mm: a comparison between in vivo maturation and in vitro maturation in non-hCG primed cycles using cumulus cell gene expression. Mol Hum Reprod. 2013 Jan;19(1):7-16. doi: 10.1093/molehr/gas038. Epub 2012 Sep 6. — View Citation
Guzman L, Ortega-Hrepich C, Albuz FK, Verheyen G, Devroey P, Smitz J, De Vos M. Developmental capacity of in vitro-matured human oocytes retrieved from polycystic ovary syndrome ovaries containing no follicles larger than 6 mm. Fertil Steril. 2012 Aug;98(2):503-7.e1-2. doi: 10.1016/j.fertnstert.2012.01.114. Epub 2012 Feb 23. — View Citation
Heijnen EM, Eijkemans MJ, Hughes EG, Laven JS, Macklon NS, Fauser BC. A meta-analysis of outcomes of conventional IVF in women with polycystic ovary syndrome. Hum Reprod Update. 2006 Jan-Feb;12(1):13-21. Epub 2005 Aug 25. — View Citation
Ho VNA, Braam SC, Pham TD, Mol BW, Vuong LN. The effectiveness and safety of in vitro maturation of oocytes versus in vitro fertilization in women with a high antral follicle count. Hum Reprod. 2019 Jun 4;34(6):1055-1064. doi: 10.1093/humrep/dez060. — View Citation
Sánchez F, Lolicato F, Romero S, De Vos M, Van Ranst H, Verheyen G, Anckaert E, Smitz JEJ. An improved IVM method for cumulus-oocyte complexes from small follicles in polycystic ovary syndrome patients enhances oocyte competence and embryo yield. Hum Reprod. 2017 Oct 1;32(10):2056-2068. doi: 10.1093/humrep/dex262. — View Citation
Ziebe S, Loft A, Povlsen BB, Erb K, Agerholm I, Aasted M, Gabrielsen A, Hnida C, Zobel DP, Munding B, Bendz SH, Robertson SA. A randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization. Fertil Steril. 2013 May;99(6):1600-9. doi: 10.1016/j.fertnstert.2012.12.043. Epub 2013 Feb 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blastulation rate | Percentage of blastocyst by 2 types of IVM culture with or without GM-CSF | At least seven days after oocyte pick up | |
Secondary | Embryology data (maturation rate, fertilization rate, grade 1 and grade 2 blastocyst rate) | Maturation rate: percentage of mature oocyte over oocytes pick-up by 2 types of IVM culture Fertilization rate: percentage of 2PN over oocytes injected by 2 types of IVM culture Grade 1 and 2 blastocyst rate: percentage of grade 1 and 2 blastocyst over total number of blastocysts by 2 types of IVM culture | Maturation rate: 2 days after OPU, Fertilization rate: 3 days after OPU, grade 1 and 2 blastocyst: at least 7 days after OPU | |
Secondary | Ongoing Pregnancy Rate after the first transfer of the started treatment cycle. | Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer. | At 12 weeks' gestation | |
Secondary | Cumulative ongoing pregnancy rate at 6 months after randomization | Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after transfer of all embryos from the started treatment cycle. | At 12 weeks' gestation at 6 months after randomization. After 6 months, most patients doing IVM have finished all their frozen embryos; therefore, we consider this time point for analyzing the cumulative ongoing pregnancy rate. | |
Secondary | Adverse events (OHSS rate, miscarriage rate, ectopic rate) | OHSS rate: Routine assessments for OHSS were performed on day 3 post oocyte retrieval in both groups. At other times, OHSS was evaluated if symptoms were reported by the patient. OHSS was classified using the flow diagram developed by Humaidan and colleagues for use in clinical trial settings Miscarriage defined as spontaneous loss of a clinical pregnancy before week 22 of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus.
Ectopic pregnancy defined as a pregnancy in which implantation takes place outside the uterine cavity |
OHSS rate: at 03 days after oocytes pick-up and 14 days after embryo transfer, Miscarriage rate: Before 22 weeks of gestational age, ectopic rate: At 5-7 weeks of gestation | |
Secondary | The relative expression ratio ( R ) of human cumulus cell genes | Cumulus cells (CCc) will be collected, cDNA synthesis after mRNA purification, relative quantification PCR for detecting gene expression between CCs of GM-CSF group and CCs of control group. | cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification | |
Secondary | Infant DNA methylation expression level | Newborn's material (cord blood, buccal smears, placental tissue) will be collected for epigenetics analysis.
Computational pipeline for genome-wide bisulfite sequencing data analysis. Reads from bisulfite sequencing are first aligned to the reference genome. The alignment data may be visualized in different tracks for comparison (control group vs GM-CSF group). After methylation calling, the bulk methylation level and genome-wide methylation level are calculated and plotted, and DMRs (differentially methylated regions) are determined. To perform an integrative analysis, DNA methylation data are coupled with gene expression, e.g., differentially genes (DEGs), to delineate the regulatory role of DNA methylation. |
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