IVFNCT04774432
Effect of GM-CSF on CAPA-IVM System Success Rates in PCOS
A study testing GM-CSF group in people with IVF and PCOS, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- What is being tested?
- GM-CSF group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed as PCOS using Rotterdam criteria (AFC=25 or the ovarian volume >10ml)
- Agree to participate in the study
Who cannot join
- No major uterine or ovarian abnormalities
- Endometriosis grade 2 or upper
- Severe OAT (concentration <1 million/ml, motility <10%), surgical sperm
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
My Duc Hospital
Ho Chi Minh City
Vinh Q Dang, MD
About this study
Official title: Effect of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on Human in Vitro Oocyte Maturation (CAPA-IVM System) Success Rates in PCOS
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.
Read the detailed description
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).
Typically, IVM will be offered to women with polycystic ovaries (PCO/PCOS), or to patients with an excellent ovarian reserve, i.e. a high antral follicle count. IVM treatment is characterized by minimal administration of FSH or HMG and NO HCG ovulation trigger.
The IVM approach is less disruptive to patients' daily life through the reduced need for hormonal and ultrasound monitoring, avoids a range of minor and major complications, such as ovarian hyperstimulation syndrome, and aims to reduce the total cost of infertility treatment for the patient and for the health care budget.
Human oocytes retrieved from small antral follicles are able to resume meiosis by undergoing germinal vesicle breakdown and extrusion of the first polar body, if they have reached meiotic competence. These oocytes can be fertilized although only a proportion (less than 50%) of them can develop further into viable embryos. It has been hypothesized that failure of embryonic development may, at least in part, be due to an immature oocyte cytoplasm.
The investigators have developed a novel human in vitro maturation (IVM) culture system (named CAPACITATION-IVM , hereafter named "CAPA") using 1°) natural compounds known to influence cGMP and cAMP levels within the cumulus-oocyte-complex and 2°) compounds that are crucial for the oocyte-cumulus cross-talk. Keeping cyclic AMP high after retrieval in the GV oocyte prevents occurrence of nuclear maturation, enabling increased communication between the oocyte and the cumulus cells. This allows for the improvement in the synchronization of nuclear and cytoplasmic maturation processes in the oocyte, to the benefit of embryo quality.
The clinical outcomes of using CAPA-IVM in PCOS instead of fully stimulated GnRH-antagonist HP-HMG stimulated IVF-ICSI treatments showed equivalent live-birth rates after a first embryo transfer cycle done in artificial endometrial preparation in the two arms. Nevertheless, the CAPA-IVM cumulative live birth at 12 months was 44%, while in IVF it was 62,6. (Vuong et al., 2020). Hence the attrition rate of embryos in CAPA-IVM is larger than in conventional ART. In order to correct for this difference in good embryo number there is a need to refine the culture conditions.
This pilot study aims to evaluate the addition of an important growth factor known as Granulocyte macrophage colony stimulating factor (GM-CSF). In a recent breakthrough it has been shown that adding GM-CSF to IVM media can improve preimplantation embryo development in pigs, cattle and mice (unpublished results from Prof Mark Nottle, Adelaide University, Australia). Moreover, in mice, these improvements lead to an increased in implantation rate (+62%) and tended to increase birth rate (+25%) following the transfer of vitrified/warmed blastocysts compared with standard IVM. Based on these findings, this pilot study aims to determine the beneficial effect of using GM-CSF during the biphasic CAPA-IVM. 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.
GM-CSF (Leukine in EmbryoGene medium, Medicult) has previously been used as an additive in embryo culture in order to increase the implantation rate of exposed embryos. This study in more than 1000 patients showed no advantage of adding GMCSF routinely. However in a subset of patients, those with poor implantation, the addition of this factor improved clinical results (Ziebe et al., 2013). In this study no safety issues were mentioned by exposing human oocytes during fertilization and early embryo formation.
In the intended study there will be only exposure of GM-CSF during the oocyte maturation steps, and the embryos will never be in direct contact with the investigational compound.
- Being tested
- GM-CSF group, Control group
- Keywords
- GM-CSF, CAPA-IVM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSF groupOther
GM-CSF added to CAPA and maturation medium
Control groupOther
GM-CSF will not be added to CAPA and maturation medium
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF group | Active comparator | Patients will be randomly allocated to intervention group with GM-CSF added to CAPA and maturation medium.
Following the 24h CAPA period, the evaluation of maturation (MII, GVBD, GV) will be done after 30 hrs IVM step.
Mature eggs are fertilized using Intracytoplasmic sperm injection (ICSI). Fertilized oocytes will be placed in a time-lapse incubator (ASTEC) and their development until the Day 5/6 (blastocyst formation) will be followed. Receives: Other: GM-CSF group |
| Control group | Active comparator | Patients will be randomly allocated to control group without the addition of GM-CSF to CAPA and maturation medium.
Following the 24h CAPA period, the evaluation of maturation (MII, GVBD, GV) will be done after 30 hrs IVM step.
Mature eggs are fertilized using Intracytoplasmic sperm injection (ICSI). Fertilized oocytes will be placed in a time-lapse incubator (ASTEC) and their development until the Day 5/6 (blastocyst formation) will be followed. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation rate
Percentage of blastocyst by 2 types of IVM culture with or without GM-CSF
Measured: At least seven days after oocyte pick up
Secondary outcomes (6)
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
Measured: Maturation rate: 2 days after OPU, Fertilization rate: 3 days after OPU, grade 1 and 2 blastocyst: at least 7 days after OPU
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.
Measured: At 12 weeks' gestation
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.
Measured: 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.
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
Measured: 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
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.
Measured: cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification
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.
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start10 Mar 2021
- Primary completion2 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, MD, Principal investigator, Hope Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774432
- Sponsor's protocol ID
- 01/21/DD-BVMD
- Status last verified
- Jul 2021
- First submitted
- 24 Feb 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22365339Guzman 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.
PubMed 22956770Heijnen 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. doi: 10.1093/humupd/dmi036. Epub 2005 Aug 25.
PubMed 16123051Sanchez 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.
PubMed 28938744Ho 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.
PubMed 31111879Ziebe 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.
PubMed 23380186
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on Human in Vitro Oocyte Maturation (CAPA-IVM System) Success Rates in PCOS
- ClinicalTrials.gov ID
- NCT04774432
- Acronym / sponsor ID
- 01/21/DD-BVMD
- Keywords
- GM-CSF, CAPA-IVM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 2 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Typically, IVM will be offered to women with polycystic ovaries (PCO/PCOS), or to patients with an excellent ovarian reserve, i.e. a high antral follicle count. IVM treatment is characterized by minimal administration of FSH or HMG and NO HCG ovulation trigger.
The IVM approach is less disruptive to patients' daily life through the reduced need for hormonal and ultrasound monitoring, avoids a range of minor and major complications, such as ovarian hyperstimulation syndrome, and aims to reduce the total cost of infertility treatment for the patient and for the health care budget.
Human oocytes retrieved from small antral follicles are able to resume meiosis by undergoing germinal vesicle breakdown and extrusion of the first polar body, if they have reached meiotic competence. These oocytes can be fertilized although only a proportion (less than 50%) of them can develop further into viable embryos. It has been hypothesized that failure of embryonic development may, at least in part, be due to an immature oocyte cytoplasm.
The investigators have developed a novel human in vitro maturation (IVM) culture system (named CAPACITATION-IVM , hereafter named "CAPA") using 1°) natural compounds known to influence cGMP and cAMP levels within the cumulus-oocyte-complex and 2°) compounds that are crucial for the oocyte-cumulus cross-talk. Keeping cyclic AMP high after retrieval in the GV oocyte prevents occurrence of nuclear maturation, enabling increased communication between the oocyte and the cumulus cells. This allows for the improvement in the synchronization of nuclear and cytoplasmic maturation processes in the oocyte, to the benefit of embryo quality.
The clinical outcomes of using CAPA-IVM in PCOS instead of fully stimulated GnRH-antagonist HP-HMG stimulated IVF-ICSI treatments showed equivalent live-birth rates after a first embryo transfer cycle done in artificial endometrial preparation in the two arms. Nevertheless, the CAPA-IVM cumulative live birth at 12 months was 44%, while in IVF it was 62,6. (Vuong et al., 2020). Hence the attrition rate of embryos in CAPA-IVM is larger than in conventional ART. In order to correct for this difference in good embryo number there is a need to refine the culture conditions.
This pilot study aims to evaluate the addition of an important growth factor known as Granulocyte macrophage colony stimulating factor (GM-CSF). In a recent breakthrough it has been shown that adding GM-CSF to IVM media can improve preimplantation embryo development in pigs, cattle and mice (unpublished results from Prof Mark Nottle, Adelaide University, Australia). Moreover, in mice, these improvements lead to an increased in implantation rate (+62%) and tended to increase birth rate (+25%) following the transfer of vitrified/warmed blastocysts compared with standard IVM. Based on these findings, this pilot study aims to determine the beneficial effect of using GM-CSF during the biphasic CAPA-IVM. 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.
GM-CSF (Leukine in EmbryoGene medium, Medicult) has previously been used as an additive in embryo culture in order to increase the implantation rate of exposed embryos. This study in more than 1000 patients showed no advantage of adding GMCSF routinely. However in a subset of patients, those with poor implantation, the addition of this factor improved clinical results (Ziebe et al., 2013). In this study no safety issues were mentioned by exposing human oocytes during fertilization and early embryo formation.
In the intended study there will be only exposure of GM-CSF during the oocyte maturation steps, and the embryos will never be in direct contact with the investigational compound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GM-CSF group | Active comparator | Other: GM-CSF groupPatients will be randomly allocated to intervention group with GM-CSF added to CAPA and maturation medium. Following the 24h CAPA period, the evaluation of maturation (MII, GVBD, GV) will be done after 30 hrs IVM step. Mature eggs are fertilized using Intracytoplasmic sperm injection (ICSI). Fertilized oocytes will be placed in a time-lapse incubator (ASTEC) and their development until the Day 5/6 (blastocyst formation) will be followed. |
| Control group | Active comparator | Other: Control groupPatients will be randomly allocated to control group without the addition of GM-CSF to CAPA and maturation medium. Following the 24h CAPA period, the evaluation of maturation (MII, GVBD, GV) will be done after 30 hrs IVM step. Mature eggs are fertilized using Intracytoplasmic sperm injection (ICSI). Fertilized oocytes will be placed in a time-lapse incubator (ASTEC) and their development until the Day 5/6 (blastocyst formation) will be followed. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed as PCOS using Rotterdam criteria (AFC=25 or the ovarian volume >10ml)
- Agree to participate in the study
Key exclusion criteria (3 listed)
- No major uterine or ovarian abnormalities
- Endometriosis grade 2 or upper
- Severe OAT (concentration <1 million/ml, motility <10%), surgical sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GM-CSF groupGM-CSF added to CAPA and maturation medium | Other | GM-CSF group |
| Control groupGM-CSF will not be added to CAPA and maturation medium | Other | Control group |
Primary outcome
Blastulation rate
Time frame: At least seven days after oocyte pick up
Percentage of blastocyst by 2 types of IVM culture with or without GM-CSF
6 secondary outcomes
Embryology data (maturation rate, fertilization rate, grade 1 and grade 2 blastocyst rate)
Time frame: Maturation rate: 2 days after OPU, Fertilization rate: 3 days after OPU, grade 1 and 2 blastocyst: at least 7 days after OPU
Ongoing Pregnancy Rate after the first transfer of the started treatment cycle.
Time frame: At 12 weeks' gestation
Cumulative ongoing pregnancy rate at 6 months after randomization
Time frame: 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.
Adverse events (OHSS rate, miscarriage rate, ectopic rate)
Time frame: 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
The relative expression ratio ( R ) of human cumulus cell genes
Time frame: cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification
Infant DNA methylation expression level
Time frame: At the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 22365339Guzman 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.
- Background: PubMed 22956770Guzman 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.
- Background: PubMed 16123051Heijnen 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. doi: 10.1093/humupd/dmi036. Epub 2005 Aug 25.
- Background: PubMed 28938744Sanchez 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.
- Background: PubMed 31111879Ho 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.
- Background: PubMed 23380186Ziebe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, MD principal investigator
Hope Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GM-CSF group in people with IVF and PCOS, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lan N Vuong, PhD (+84903008889, drlan@yahoo.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation rate (time frame: At least seven days after oocyte pick up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04774432, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.