Apply Biphasic IVM for POSEIDON Group 1

NCT07632300 | Not Yet Recruiting

• 1 other identifier: 07/26/DD-BVMD
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Adult Females; Healthy Adult Male

Outcome Measures

Primary Outcomes (1)

• Number of matured oocytes after biphasic-IVM

  Count the number of oocytes with the first polar body extruded after biphasic IVM culture

  From enrollment to the last of treatment at 12 months

Secondary Outcomes (25)

• Number of patients have no oocyte retrieved

  From enrollment to the last of treatment at 12 months

• Number of patients have no matured oocytes after biphasic IVM

  From enrollment to the last of treatment at 12 months

• Number of patients have no embryos

  From enrollment to the end of treatment at 12 months

• Recovery rate

  From enrollment to the end of treatment at 12 months

• Maturation rate

  From enrollment to the end of treatment at 12 month

Study Arms (1)

Biphasic-IVM

EXPERIMENTAL

Participants in this arm will undergo a biphasic In Vitro Maturation (IVM) protocol

Procedure: Biphasic-IVM

Interventions

Biphasic-IVM PROCEDURE

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.

Biphasic-IVM

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Egg-donation cycle
• Uterine abnormalities: adenomyosis, large uterine fibroids (≥5 cm), bicornuate uterus, uterine adhesions.
• Sperm surgical (PESA, TESE, mTESE)

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

IVFMD, My Duc Hospital

Ho Chi Minh City, Hồ Chí Minh, 70000, Vietnam

Location

Related Publications (10)

• 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.

  PMID: 24592113 RESULT

• Alviggi 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.

  PMID: 30386293 RESULT

• Conforti 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.

  PMID: 30728019 RESULT

• Haahr 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.

  PMID: 29523204 RESULT

• Grynberg, M. and Fanchin, R. (2021) 'IVM in non-PCOS indications', in In Vitro Maturation of Human Oocytes. CRC Press.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

Study Officials

• Ho L. Le, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho L. Le, MD

CONTACT

+84356177147; bsho.ll@myduchospital.vn

Tuong M Ho, MD

CONTACT

+84903633377‬; tuongho.ivfmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)