Healthy Adult FemalesPOSEIDON-IaNCT07632300
Apply Biphasic IVM for POSEIDON Group 1
A study testing Biphasic-IVM in people with Healthy Adult Females and Healthy Adult Male, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if biphasic In Vitro Maturation (IVM) works to help young women who produce very few oocytes after controlled ovarian stimulation. The study focuses on women under age 35 who have a good number of follicles in their ovaries but do not respond well to standard ovarian… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Healthy Adult Females, Healthy Adult Male
- What is being tested?
- Biphasic-IVM
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteVietnam
- Study dates
- 12 Jun 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 - < 35 years
- At least one IVF cycle have been failed and classified as having a poor response to POSEIDON group Ia.
- POSEIDON group Ia ( < 35 age; AMH >= 1.2 ng/ml and/or AFC >=5 antral follicles; have < 4 oocytes was retrieved at previous IVF cycle)
- Agree to apply biphasic-IVM treatment.
- Agree to freeze all embryos and to transfer the frozen embryos afterward.
- Agree to participate in the study.
Who cannot join
- Egg-donation cycle
- Uterine abnormalities: adenomyosis, large uterine fibroids (≥5 cm), bicornuate uterus, uterine adhesions.
- Sperm surgical (PESA, TESE, mTESE)
- PGT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
IVFMD, My Duc Hospital
Ho Chi Minh City, Hồ Chí Minh, 70000
Ho L. Le, MD, 84356177147, bsho.ll@myduchospital.vn
About this study
Official title: Efficacy and Safety of Biphasic IVM in Low Prognosis Patients Classified as Poseidon Group 1A
The goal of this clinical trial is to learn if biphasic In Vitro Maturation (IVM) works to help young women who produce very few oocytes after controlled ovarian stimulation. The study focuses on women under age 35 who have a good number of follicles in their ovaries but do not respond well to standard ovarian stimulation by Gonadotropin (known as POSEIDON Group 1a).
The main questions it aims to answer are:
Read more
How many mature oocytes can be obtain after biphasic -VM? Researchers will use biphasic-IVM system to see if it can bypass the problems these patients face with standard treatments, such as high costs and the risk of medical complications like Ovarian Hyperstimulation Syndrome (OHSS).
Participants will:
Have their immature eggs collected from the ovaries without the need for high-dose hormone injections.
Have their eggs matured in a specialized laboratory using a two-step process (biphasic IVM) to improve egg quality.
Follow up with researchers to check the number of embryos created and the safety of the procedure.
Read the detailed description
In assisted reproductive technology (ART), patients with poor or suboptimal ovarian response to controlled ovarian hyperstimulation pose significant clinical challenges, leading to the development of the POSEIDON classification in 2016. In particular, POSEIDON group 1a includes young patients (under 35 years of age) with normal ovarian reserve parameters (AFC ≥5 and/or AMH ≥1.2 ng/mL) who nevertheless have a low number of retrieved oocytes (<4 oocytes) following standard ovarian stimulation. The cause of this is often attributed to genetic factors, such as FSH receptor (FSHR) or LH receptor (LHR) polymorphisms, leading to ovarian resistance or reduced sensitivity to exogenous gonadotropins". Current traditional IVF treatment strategies for this group typically focus on increasing gonadotropin dosages, adding recombinant LH, or applying double stimulation protocols (DuoStim) to maximize the number of oocytes retrieved and obtain at least one euploid blastocyst. However, these approaches not only substantially increase treatment costs and the psychological burden on patients, but may also elevate the risk of ovarian hyperstimulation syndrome (OHSS) due to the presence of a high number of antral follicles. Moreover, their true effectiveness remains controversial, as the pathophysiology is related to reduced receptor sensitivity rather than a simple hormonal deficiency.
The application of biphasic IVM in POSEIDON group 1 patients represents a biologically and clinically rational strategy. This technique leverages the advantage of preserved ovarian reserve (a high number of small follicles) to retrieve immature oocytes without relying on high-dose gonadotropin stimulation, thereby bypassing receptor resistance mechanisms. In addition, it nearly eliminates the risk of OHSS and reduces treatment costs. Previous studies investigating IVM in patients with poor ovarian response mainly focused on rescuing immature oocytes retrieved during conventional stimulation cycles (rescue-IVM) to increase embryo availability. However, pregnancy outcomes derived from rescue-IVM have generally been low.
Biphasic IVM offers a promising alternative approach. This protocol includes a prematuration phase using C-type Natriuretic Peptide (CNP) to temporarily arrest meiotic progression for 24 hours, thereby restoring synchronization between nuclear and cytoplasmic maturation, followed by a 30-hour maturation phase. This strategy significantly improves oocyte developmental competence and blastocyst formation rates. The aim of this study is to evaluate the efficacy and safety of biphasic IVM in patients classified as POSEIDON Group 1a.
- Conditions
- Healthy Adult Females, Healthy Adult Male
- Being tested
- Biphasic-IVM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic-IVMProcedure or surgery
After consenting to undergo biphasic IVM, patients will be scheduled for immature oocyte retrieval between cycle days 1 and 6. No FSH, hMG, hCG, or GnRH agonist will be administered for oocyte maturation. Oocyte retrieval will be performed transvaginally under ultrasound guidance. A 20G aspiration needle (Kitazato®, Japan or Vitrolife®, Sweden) will be connected to a suction device with a negative pressure of -120 mmHg.
Follicular fluid will be transferred to the laboratory for oocyte identification under a stereomicroscope and filtered using a mesh system to avoid oocyte loss. Cumulus-oocyte complexes (COCs) will be washed and placed into four-well culture dishes containing CAPA medium. After 24 hours of prematuration culture in CAPA medium, the oocytes will be transferred to IVM medium for an additional 30 hours. Subsequently, oocytes will be denuded and assessed for nuclear maturation status. Mature oocytes obtained after IVM culture will undergo intracytoplasmic sperm injection.
| Study group | Role | What they receive |
|---|---|---|
| Biphasic-IVM | Experimental | Participants in this arm will undergo a biphasic In Vitro Maturation (IVM) protocol Receives: Procedure: Biphasic-IVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of matured oocytes after biphasic-IVM
Count the number of oocytes with the first polar body extruded after biphasic IVM culture
Measured: From enrollment to the last of treatment at 12 months
Secondary outcomes (25)
Number of patients have no oocyte retrieved
Count the number of patients with no oocytes retrieved
Measured: From enrollment to the last of treatment at 12 months
Number of patients have no matured oocytes after biphasic IVM
Count the number of patients with no matured oocytes after biphasic IVM
Measured: From enrollment to the last of treatment at 12 months
Number of patients have no embryos
Count the number of patients with no embryos
Measured: From enrollment to the end of treatment at 12 months
Recovery rate
Number of GV oocytes/number of follicles
Measured: From enrollment to the end of treatment at 12 months
Maturation rate
Number of matured oocytes after biphasic-IVM/number of GV oocytes
Measured: From enrollment to the end of treatment at 12 month
Number of fertilized oocytes
Number of 2PN oocytes after ICSI 16 - 18 hours
Measured: From enrollment to the last of treatment at 12 months
Number of embryos day-3 oocytes
Number of cleavage embryos after ICSI 64 hours
Measured: From enrollment to the last of treatment at 12 months
Day-3 embryos rate
Number of day-3 embryos/number of 2PN
Measured: From enrollment to the last of treatment at 12 months
Number of good embryos day-3
Mean number of usable embryos day-3
Measured: From enrollment to the last of treatment at 12 months
Number of frozen embryos day-3
Mean number of Day-3 cryopreserved embryos
Measured: From enrollment to the last of treatment at 12 months
Number of blastocyst embryos
Mean number of Day-5 embryos
Measured: From enrollment to the last of treatment at 12 months
Blastocyst rate
Number of blastocyst/ number of 2 PN
Measured: From enrollment to the last of treatment at 12 months
Number of good blastocyst embryos
Mean number of usable blastocyts embryos
Measured: From enrollment to the last of treatment at 12 months
Number of frozen blastocyst embryos
Mean number of Day-5 cryopreserved embryos
Measured: From enrollment to the last of treatment at 12 months
Pregnancy rate
Serum beta-hCG level > 25 mIU/ml after transfer 11 - 13 days
Measured: From enrollment to the last of treatment at 12 months
Implantion rate
Number of visible gestational sac (included ectopic pregnancy)/ number of embryos transferred
Measured: From enrollment to the last of treatment at 12 months
Clinical pregnancy rate
At least one gestational sac was observed on ultrasound at 7 gestational weeks
Measured: From enrollment to the end of treatment at 12 months
Ongoing pregnancy rate
At least one fetus with heart beat was observed on ultrasound at 12 gestational weeks
Measured: From enrollment to the end of treatment at 12 moths
Live birth rate
The complete expulsion or extraction of a product of human conception from its mother irrespective of pregnancy duration which, after separation, breathes or shows any sign of life, such as a beating heart, umbilical cord pulsation, or voluntary muscle movement
Measured: From enrollment to the end of treatment at 12 moths
Ectopic pregnancy rate
Percentage of patients with ectopic pregnancy
Measured: From enrollment to the end of treatment at 12 months
Miscarriage rate < 12 gestational weeks
Percentage of patients with miscarriage pregnancy < 12 weeks
Measured: From enrollment to the end of treatment at 12 months
Multiple pregnancy rate
Percentage of patients with multiple pregnancy (> 1 gestational sac)
Measured: From enrollment to the end of treatment at 12 months
OHSS rate
Percentage of patients with OHSS requiring hospitalization
Measured: From enrollment to the end of treatment at 12 months
Internal bleeding after OPU
Percentage of patients with internal bleeding after OPU requiring hospitalization
Measured: From enrollment to the end of treatment at 12 months
Fertilization rate
Number of 2PN/ Number of MII
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start12 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult FemalesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho L. Le, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632300
- Sponsor's protocol ID
- 07/26/DD-BVMD
- Acronym
- POSEIDON-Ia
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yalcinkaya E, Caliskan E, Budak O. In vitro maturation may prevent the cancellation of in vitro fertilization cycles in poor responder patients: A case report. J Turk Ger Gynecol Assoc. 2013 Jul 10;14(4):235-7. doi: 10.5152/jtgga.2013.68335. eCollection 2013.
PubMed 24592113Alviggi C, Conforti A, Esteves SC, Vallone R, Venturella R, Staiano S, Castaldo E, Andersen CY, De Placido G. Understanding Ovarian Hypo-Response to Exogenous Gonadotropin in Ovarian Stimulation and Its New Proposed Marker-The Follicle-To-Oocyte (FOI) Index. Front Endocrinol (Lausanne). 2018 Oct 17;9:589. doi: 10.3389/fendo.2018.00589. eCollection 2018.
PubMed 30386293Conforti A, Esteves SC, Di Rella F, Strina I, De Rosa P, Fiorenza A, Zullo F, De Placido G, Alviggi C. The role of recombinant LH in women with hypo-response to controlled ovarian stimulation: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2019 Feb 6;17(1):18. doi: 10.1186/s12958-019-0460-4.
PubMed 30728019Haahr T, Esteves SC, Humaidan P. Individualized controlled ovarian stimulation in expected poor-responders: an update. Reprod Biol Endocrinol. 2018 Mar 9;16(1):20. doi: 10.1186/s12958-018-0342-1.
PubMed 29523204Grynberg, M. and Fanchin, R. (2021) 'IVM in non-PCOS indications', in In Vitro Maturation of Human Oocytes. CRC Press.
Herrero, L., Pareja, S., Losada, C. and Cobo, A. (2018) 'In vitro maturation (IVM) for patients with poor ovarian response: a pilot study', Journal of Clinical Medicine, 7(12), p. 524.
Humaidan, P., Alviggi, C., Fischer, R. and Esteves, S.C. (2016) 'The 'POSEIDON' stratification of 'Low Prognosis Patients in Assisted Reproductive Technology': we can stop looking for the ideal patient', Human Reproduction, 31(10), pp. 2201-2211.
Kushnir, V.A., Gleicher, N., Barad, D.H. and Albertini, D.F. (2018) 'A single-center study of in vitro maturation in patients with low ovarian reserve', Journal of Ovarian Research, 11(1), pp. 1-6.
Sanchez, F., Leuzinger, L., Romero, S., De Vos, M., Heindryckx, B. and Smitz, J. (2019) 'In vitro maturation with a prematuration step (CAPA-IVM) improves the meiotic and developmental capacity of human oocytes', Human Reproduction, 34, pp. 1-15.
Vuong, L.N., Le, A.H., Ho, V.N.A., Pham, T.D., Sanchez, F., Leuzinger, L., Heindryckx, B., Smitz, J. and Mol, B.W. (2020) 'Effectiveness of biphasic in vitro maturation in women with polycystic ovary syndrome: a randomized controlled trial', Human Reproduction, 35(12), pp. 2737-2747.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Biphasic IVM in Low Prognosis Patients Classified as Poseidon Group 1A
- ClinicalTrials.gov ID
- NCT07632300
- Acronym / sponsor ID
- POSEIDON-Ia / 07/26/DD-BVMD
- Conditions
- Healthy Adult Females, Healthy Adult Male
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 8 Jun 2026 (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.
The goal of this clinical trial is to learn if biphasic In Vitro Maturation (IVM) works to help young women who produce very few oocytes after controlled ovarian stimulation. The study focuses on women under age 35 who have a good number of follicles in their ovaries but do not respond well to standard ovarian stimulation by Gonadotropin (known as POSEIDON Group 1a).
The main questions it aims to answer are:
How many mature oocytes can be obtain after biphasic -VM? Researchers will use biphasic-IVM system to see if it can bypass the problems these patients face with standard treatments, such as high costs and the risk of medical complications like Ovarian Hyperstimulation Syndrome (OHSS).
Participants will:
Have their immature eggs collected from the ovaries without the need for high-dose hormone injections.
Have their eggs matured in a specialized laboratory using a two-step process (biphasic IVM) to improve egg quality.
Follow up with researchers to check the number of embryos created and the safety of the procedure.
Detailed description
In assisted reproductive technology (ART), patients with poor or suboptimal ovarian response to controlled ovarian hyperstimulation pose significant clinical challenges, leading to the development of the POSEIDON classification in 2016. In particular, POSEIDON group 1a includes young patients (under 35 years of age) with normal ovarian reserve parameters (AFC ≥5 and/or AMH ≥1.2 ng/mL) who nevertheless have a low number of retrieved oocytes (<4 oocytes) following standard ovarian stimulation. The cause of this is often attributed to genetic factors, such as FSH receptor (FSHR) or LH receptor (LHR) polymorphisms, leading to ovarian resistance or reduced sensitivity to exogenous gonadotropins". Current traditional IVF treatment strategies for this group typically focus on increasing gonadotropin dosages, adding recombinant LH, or applying double stimulation protocols (DuoStim) to maximize the number of oocytes retrieved and obtain at least one euploid blastocyst. However, these approaches not only substantially increase treatment costs and the psychological burden on patients, but may also elevate the risk of ovarian hyperstimulation syndrome (OHSS) due to the presence of a high number of antral follicles. Moreover, their true effectiveness remains controversial, as the pathophysiology is related to reduced receptor sensitivity rather than a simple hormonal deficiency.
The application of biphasic IVM in POSEIDON group 1 patients represents a biologically and clinically rational strategy. This technique leverages the advantage of preserved ovarian reserve (a high number of small follicles) to retrieve immature oocytes without relying on high-dose gonadotropin stimulation, thereby bypassing receptor resistance mechanisms. In addition, it nearly eliminates the risk of OHSS and reduces treatment costs. Previous studies investigating IVM in patients with poor ovarian response mainly focused on rescuing immature oocytes retrieved during conventional stimulation cycles (rescue-IVM) to increase embryo availability. However, pregnancy outcomes derived from rescue-IVM have generally been low.
Biphasic IVM offers a promising alternative approach. This protocol includes a prematuration phase using C-type Natriuretic Peptide (CNP) to temporarily arrest meiotic progression for 24 hours, thereby restoring synchronization between nuclear and cytoplasmic maturation, followed by a 30-hour maturation phase. This strategy significantly improves oocyte developmental competence and blastocyst formation rates. The aim of this study is to evaluate the efficacy and safety of biphasic IVM in patients classified as POSEIDON Group 1a.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biphasic-IVM | Experimental | Procedure: Biphasic-IVMParticipants in this arm will undergo a biphasic In Vitro Maturation (IVM) protocol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 - < 35 years
- At least one IVF cycle have been failed and classified as having a poor response to POSEIDON group Ia.
- POSEIDON group Ia ( < 35 age; AMH >= 1.2 ng/ml and/or AFC >=5 antral follicles; have < 4 oocytes was retrieved at previous IVF cycle)
- Agree to apply biphasic-IVM treatment.
- Agree to freeze all embryos and to transfer the frozen embryos afterward.
Key exclusion criteria (4 listed)
- Egg-donation cycle
- Uterine abnormalities: adenomyosis, large uterine fibroids (≥5 cm), bicornuate uterus, uterine adhesions.
- Sperm surgical (PESA, TESE, mTESE)
- PGT
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 |
|---|---|---|
| Biphasic-IVMAfter consenting to undergo biphasic IVM, patients will be scheduled for immature oocyte retrieval between cycle days 1 and 6. No FSH, hMG, hCG, or GnRH agonist will be administered for oocyte maturation. Oocyte retrieval will be performed transvaginally under ultrasound guidance. A 20G aspiration needle (Kitazato®, Japan or Vitrolife®, Sweden) will be connected to a suction device with a negative pressure of -120 mmHg. Follicular fluid will be transferred to the laboratory for oocyte identification under a stereomicroscope and filtered using a mesh system to avoid oocyte loss. Cumulus-oocyte complexes (COCs) will be washed and placed into four-well culture dishes containing CAPA medium. After 24 hours of prematuration culture in CAPA medium, the oocytes will be transferred to IVM medium for an additional 30 hours. Subsequently, oocytes will be denuded and assessed for nuclear maturation status. Mature oocytes obtained after IVM culture will undergo intracytoplasmic sperm injection. | Procedure or surgery | Biphasic-IVM |
Primary outcome
Number of matured oocytes after biphasic-IVM
Time frame: From enrollment to the last of treatment at 12 months
Count the number of oocytes with the first polar body extruded after biphasic IVM culture
25 secondary outcomes
Number of patients have no oocyte retrieved
Time frame: From enrollment to the last of treatment at 12 months
Number of patients have no matured oocytes after biphasic IVM
Time frame: From enrollment to the last of treatment at 12 months
Number of patients have no embryos
Time frame: From enrollment to the end of treatment at 12 months
Recovery rate
Time frame: From enrollment to the end of treatment at 12 months
Maturation rate
Time frame: From enrollment to the end of treatment at 12 month
Number of fertilized oocytes
Time frame: From enrollment to the last of treatment at 12 months
Number of embryos day-3 oocytes
Time frame: From enrollment to the last of treatment at 12 months
Day-3 embryos rate
Time frame: From enrollment to the last of treatment at 12 months
Number of good embryos day-3
Time frame: From enrollment to the last of treatment at 12 months
Number of frozen embryos day-3
Time frame: From enrollment to the last of treatment at 12 months
Number of blastocyst embryos
Time frame: From enrollment to the last of treatment at 12 months
Blastocyst rate
Time frame: From enrollment to the last of treatment at 12 months
Number of good blastocyst embryos
Time frame: From enrollment to the last of treatment at 12 months
Number of frozen blastocyst embryos
Time frame: From enrollment to the last of treatment at 12 months
Pregnancy rate
Time frame: From enrollment to the last of treatment at 12 months
Implantion rate
Time frame: From enrollment to the last of treatment at 12 months
Clinical pregnancy rate
Time frame: From enrollment to the end of treatment at 12 months
Ongoing pregnancy rate
Time frame: From enrollment to the end of treatment at 12 moths
Live birth rate
Time frame: From enrollment to the end of treatment at 12 moths
Ectopic pregnancy rate
Time frame: From enrollment to the end of treatment at 12 months
Miscarriage rate < 12 gestational weeks
Time frame: From enrollment to the end of treatment at 12 months
Multiple pregnancy rate
Time frame: From enrollment to the end of treatment at 12 months
OHSS rate
Time frame: From enrollment to the end of treatment at 12 months
Internal bleeding after OPU
Time frame: From enrollment to the end of treatment at 12 months
Fertilization rate
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 24592113Yalcinkaya E, Caliskan E, Budak O. In vitro maturation may prevent the cancellation of in vitro fertilization cycles in poor responder patients: A case report. J Turk Ger Gynecol Assoc. 2013 Jul 10;14(4):235-7. doi: 10.5152/jtgga.2013.68335. eCollection 2013.
- Results publication: PubMed 30386293Alviggi C, Conforti A, Esteves SC, Vallone R, Venturella R, Staiano S, Castaldo E, Andersen CY, De Placido G. Understanding Ovarian Hypo-Response to Exogenous Gonadotropin in Ovarian Stimulation and Its New Proposed Marker-The Follicle-To-Oocyte (FOI) Index. Front Endocrinol (Lausanne). 2018 Oct 17;9:589. doi: 10.3389/fendo.2018.00589. eCollection 2018.
- Results publication: PubMed 30728019Conforti A, Esteves SC, Di Rella F, Strina I, De Rosa P, Fiorenza A, Zullo F, De Placido G, Alviggi C. The role of recombinant LH in women with hypo-response to controlled ovarian stimulation: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2019 Feb 6;17(1):18. doi: 10.1186/s12958-019-0460-4.
- Results publication: PubMed 29523204Haahr T, Esteves SC, Humaidan P. Individualized controlled ovarian stimulation in expected poor-responders: an update. Reprod Biol Endocrinol. 2018 Mar 9;16(1):20. doi: 10.1186/s12958-018-0342-1.
- Results publicationGrynberg, M. and Fanchin, R. (2021) 'IVM in non-PCOS indications', in In Vitro Maturation of Human Oocytes. CRC Press.
- Results publicationHerrero, L., Pareja, S., Losada, C. and Cobo, A. (2018) 'In vitro maturation (IVM) for patients with poor ovarian response: a pilot study', Journal of Clinical Medicine, 7(12), p. 524.
- Results publicationHumaidan, P., Alviggi, C., Fischer, R. and Esteves, S.C. (2016) 'The 'POSEIDON' stratification of 'Low Prognosis Patients in Assisted Reproductive Technology': we can stop looking for the ideal patient', Human Reproduction, 31(10), pp. 2201-2211.
- Results publicationKushnir, V.A., Gleicher, N., Barad, D.H. and Albertini, D.F. (2018) 'A single-center study of in vitro maturation in patients with low ovarian reserve', Journal of Ovarian Research, 11(1), pp. 1-6.
- Results publicationSanchez, F., Leuzinger, L., Romero, S., De Vos, M., Heindryckx, B. and Smitz, J. (2019) 'In vitro maturation with a prematuration step (CAPA-IVM) improves the meiotic and developmental capacity of human oocytes', Human Reproduction, 34, pp. 1-15.
- Results publicationVuong, L.N., Le, A.H., Ho, V.N.A., Pham, T.D., Sanchez, F., Leuzinger, L., Heindryckx, B., Smitz, J. and Mol, B.W. (2020) 'Effectiveness of biphasic in vitro maturation in women with polycystic ovary syndrome: a randomized controlled trial', Human Reproduction, 35(12), pp. 2737-2747.
- Individual participant dataSharing planned: No
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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.
Ho L. Le, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic-IVM in people with Healthy Adult Females and Healthy Adult Male, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho L. Le, MD (+84356177147, bsho.ll@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of matured oocytes after biphasic-IVM (time frame: From enrollment to the last of treatment at 12 months). 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 NCT07632300, which also lists 10 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 17 Jun 2026.