Infertility (IVF Patients)IO-CAPANCT07858435
Intra-ovarian CAPA-IVM vs Standard IVM
A study testing CAPA-IVM, In-House CAPA-IVM Pre-Maturation Medium and Minimal-Stimulation OS-IVF in people with Infertility (IVF Patients) and Infertility, run by New Hope Fertility Center at 1 site in United States.
Trial summary
This prospective study compares two approaches to obtaining mature oocytes for fertility treatment within the same participant. Immature oocytes are first retrieved from the right ovary and matured in the laboratory using a two-step biphasic capacitation in vitro maturation method (CAPA-IVM). Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility (IVF Patients), Infertility, Infertility Female
- What is being tested?
- CAPA-IVM, In-House CAPA-IVM Pre-Maturation Medium and Minimal-Stimulation OS-IVF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, age 18 to 38 years.
- Undergoing assisted reproductive treatment for infertility.
- Both ovaries present and anatomically suitable for oocyte retrieval, with no prior oophorectomy.
- Adequate ovarian reserve for study participation, including AMH greater than 0.5 ng/mL and antral follicle count greater than 6 per ovary.
- Both ovaries considered suitable for their assigned study procedures: right ovary for CAPA-IVM and left ovary for minimal-stimulation OS-IVF.
- Access to partner or donor sperm for fertilization/ICSI according to clinic protocol.
- Willing and able to provide written informed consent and comply with study procedures and follow-up.
Who cannot join
- Severe endometriosis, Stage III or IV.
- Known diminished ovarian reserve with AMH less than 0.2 ng/mL, unless specifically permitted under an approved study amendment.
- Active pelvic infection.
- Untreated hydrosalpinx.
- Known chromosomal abnormality in either reproductive partner, unless appropriate genetic testing is planned.
- Contraindication to oocyte retrieval or sedation/anesthesia.
- Any medical or gynecologic condition that, in the investigator's judgment, would interfere with study participation, oocyte retrieval, study procedures, or participant safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
New Hope Fertility Center
New York, New York, 10021
Clinical Coordinators, 212-969-7461, coordinators@nhfc.com
About this study
Official title: A Within-Patient Comparison of CAPA-IVM (Biphasic Capacitation IVM) With the Contralateral Ovary Undergoing Minimal Controlled Ovarian Stimulation (OS-IVF)
This prospective study compares two approaches to obtaining mature oocytes for fertility treatment within the same participant. Immature oocytes are first retrieved from the right ovary and matured in the laboratory using a two-step biphasic capacitation in vitro maturation method (CAPA-IVM). Beginning on Day 5 of the same menstrual cycle, the left ovary undergoes minimal controlled ovarian stimulation followed by routine oocyte retrieval and IVF/ICSI.
The primary objective is to evaluate the maturation of CAPA-IVM oocytes to the metaphase II (MII) stage and compare reproductive laboratory outcomes between the CAPA-IVM and minimal-stimulation OS-IVF approaches. Secondary outcomes include fertilization, embryo development, blastocyst formation, embryo quality, pregnancy and live birth outcomes, and safety.
Read the detailed description
This is a prospective, within-patient comparative study in women undergoing fertility treatment. Each participant serves as her own internal control. At the Day 3 baseline visit, the right ovary is assigned to the CAPA-IVM approach and the left ovary is assigned to minimal controlled ovarian stimulation followed by IVF/ICSI. Both approaches are performed within the same menstrual cycle.
For the CAPA-IVM arm, immature oocytes are retrieved from the right ovary beginning on or after menstrual cycle Day 3, before ovarian stimulation is initiated. The right ovary is not stimulated and does not receive an ovulation trigger before oocyte collection. Retrieved cumulus-oocyte complexes are handled separately, and immature oocytes at the germinal vesicle (GV) or metaphase I (MI) stage undergo a biphasic CAPA-IVM process consisting of an initial pre-maturation/capacitation phase followed by transfer to maturation conditions and assessment for development to the metaphase II (MII) stage.
After completion of right-ovary aspiration, minimal controlled ovarian stimulation of the left ovary begins on Day 5. The protocol uses clomiphene citrate for approximately 9 days and follitropin beta for approximately 3 days, with ultrasound and/or hormonal monitoring. Final oocyte maturation is initiated with leuprolide acetate as a GnRH-agonist trigger, followed by routine oocyte retrieval from the left ovary.
Mature oocytes obtained from both approaches may undergo ICSI according to New Hope Fertility Center clinical practice. Oocyte assessment and selection for ICSI, ICSI itself, and standard embryo culture are considered clinical procedures; the research-specific component is the CAPA-IVM maturation approach and the within-patient comparison of outcomes according to ovary of origin. Oocytes and embryos are tracked separately to maintain traceability throughout fertilization, embryo culture, and subsequent clinical outcomes.
The primary endpoint is the proportion of immature CAPA-IVM oocytes that mature to the MII stage. Secondary endpoints include fertilization rate, cleavage, blastocyst formation, high-quality blastocyst formation, implantation, clinical pregnancy, ongoing pregnancy, live birth, neonatal outcomes, and safety outcomes including procedure-related complications and ovarian reserve measures.
- Conditions
- Infertility (IVF Patients), Infertility, Infertility Female
- Being tested
- CAPA-IVM, In-House CAPA-IVM Pre-Maturation Medium, Minimal-Stimulation OS-IVF
- Keywords
- In Vitro Maturation, IVM, CAPA-IVM, Biphasic In Vitro Maturation, Oocyte Maturation, Oocyte, Assisted Reproductive Technology, IVF, ICSI, Minimal Ovarian Stimulation, Controlled Ovarian Stimulation, Embryo Development, Blastocyst Formation, Female Infertility, Within-Patient Comparison
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPA-IVMProcedure or surgery
Immature cumulus-oocyte complexes are retrieved from the right ovary before ovarian stimulation and undergo a biphasic CAPA-IVM process. The first phase is a pre-maturation/capacitation culture intended to maintain meiotic arrest while supporting developmental competence. Oocytes are then transferred to maturation conditions and assessed for maturation to metaphase II (MII). Mature oocytes may subsequently undergo ICSI and standard embryo culture according to clinical practice.
In-House CAPA-IVM Pre-Maturation MediumDevice
An investigational in-house reproductive culture medium is used during the pre-maturation/capacitation phase of CAPA-IVM for immature cumulus-oocyte complexes. The proprietary formulation is prepared for use in the CAPA-IVM laboratory procedure. Following the pre-maturation phase, oocytes are transferred to maturation conditions and assessed for MII maturation.
Minimal-Stimulation OS-IVFProcedure or surgery
After completion of right-ovary CAPA-IVM aspiration, minimal controlled ovarian stimulation of the left ovary begins on menstrual cycle Day 5. The regimen includes clomiphene citrate for approximately 9 days and follitropin beta for approximately 3 days with ultrasound and/or hormonal monitoring. Final oocyte maturation is initiated using leuprolide acetate as a GnRH-agonist trigger. Oocytes are subsequently retrieved from the left ovary and undergo standard IVF/ICSI and embryo culture according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Within-Patient CAPA-IVM and Minimal-Stimulation OS-IVF | Experimental | All participants undergo a within-patient comparison in the same menstrual cycle. The right ovary undergoes retrieval of immature oocytes for CAPA-IVM beginning on or after menstrual cycle Day 3, before ovarian stimulation. The left ovary subsequently undergoes minimal controlled ovarian stimulation beginning on Day 5, followed by oocyte retrieval and standard IVF/ICSI. Outcomes are compared according to ovary and oocyte origin, with each participant serving as her own internal control. Receives: Procedure: CAPA-IVM; Device: In-House CAPA-IVM Pre-Maturation Medium; Procedure: Minimal-Stimulation OS-IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation Rate to Metaphase II (MII) Following CAPA-IVM
Proportion of immature oocytes retrieved from the CAPA-IVM ovary that reach the metaphase II (MII) stage after completion of the biphasic CAPA-IVM culture process. Maturation rate will be calculated as the number of oocytes reaching MII divided by the number of immature oocytes undergoing CAPA-IVM.
Measured: Up to approximately 54 hours after initiation of CAPA-IVM culture
Secondary outcomes (13)
Fertilization Rate
Proportion of injected MII oocytes showing normal two-pronuclear (2PN) fertilization after ICSI, analyzed by ovary/treatment origin.
Measured: At fertilization assessment following ICSI
Cleavage Rate
Proportion of normally fertilized embryos that undergo cleavage by embryo culture Day 2-3.
Measured: Day 2-3 after fertilization
Blastocyst Formation Rate
Proportion of embryos developing to the blastocyst stage, analyzed according to CAPA-IVM or minimal-stimulation OS-IVF origin.
Measured: Day 5-6 after fertilization
High-Quality Blastocyst Rate
Proportion of embryos meeting the center's predefined criteria for high-quality blastocyst morphology.
Measured: Day 5-6 after fertilization
Clinical Pregnancy Rate
Proportion of embryo transfers resulting in a clinical pregnancy confirmed by ultrasound evidence of fetal cardiac activity.
Measured: Approximately 7-8 weeks gestation
Ongoing Pregnancy Rate
Proportion of embryo transfers resulting in an ongoing pregnancy beyond 12 weeks gestation.
Measured: Greater than 12 weeks gestation
Live Birth Rate
Proportion of embryo transfers resulting in a live birth. Outcomes will be analyzed according to embryo origin when traceable.
Measured: At delivery, up to approximately 10 months after embryo transfer
Procedure-Related and Treatment-Related Adverse Events
Incidence of adverse events including ovarian hyperstimulation syndrome, egg-retrieval complications, sedation/anesthesia complications, and other study-related adverse events.
Measured: From initiation of study treatment through 6 months after treatment
Change in Serum Anti-Müllerian Hormone (AMH)
Change in serum AMH concentration from baseline to the follow-up ovarian-reserve assessment.
Measured: Baseline and 3-6 months after treatment
Gestational Age at Delivery
Gestational age at delivery among live-born infants resulting from embryos included in the study.
Measured: At delivery
Change in Antral Follicle Count (AFC)
Change in antral follicle count from baseline to the follow-up ovarian-reserve assessment.
Measured: Baseline and 3-6 months after treatment
Birth Weight
Birth weight of live-born infants resulting from embryos included in the study.
Measured: At birth
Reported Congenital Anomalies
Number and proportion of live-born infants with one or more congenital anomalies documented at birth.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies 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
- Model description
- All participants undergo the same prospective within-patient paired comparison. The right ovary is assigned to CAPA-IVM and the left ovary is assigned to minimal-stimulation OS-IVF. Immature oocytes are retrieved from the right ovary for CAPA-IVM beginning on or after menstrual cycle Day 3, before ovarian stimulation. Minimal stimulation of the left ovary begins on Day 5 of the same menstrual cycle, followed by oocyte retrieval and standard IVF/ICSI. Outcomes are compared according to ovary and oocyte origin, with each participant serving as her own internal control.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Hope Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- Embryotools
- Responsible party
- Sponsor
- Investigators
- John J Zhang, M.D. Ph.D, Principal investigator, New Hope Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858435
- Sponsor's protocol ID
- IVM-001
- Acronym
- IO-CAPA
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data are not currently planned to be made publicly available. Study results may be published or presented in aggregate form without identifying individual participants.
Publications
Gilchrist RB, Ho TM, De Vos M, Sanchez F, Romero S, Ledger WL, Anckaert E, Vuong LN, Smitz J. A fresh start for IVM: capacitating the oocyte for development using pre-IVM. Hum Reprod Update. 2024 Jan 3;30(1):3-25. doi: 10.1093/humupd/dmad023.
PubMed 37639630Vuong LN, Ho VNA, Ho TM, Dang VQ, Phung TH, Giang NH, Le AH, Pham TD, Wang R, Smitz J, Gilchrist RB, Norman RJ, Mol BW. In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial. Hum Reprod. 2020 Nov 1;35(11):2537-2547. doi: 10.1093/humrep/deaa240.
PubMed 32974672Vuong LN, Le AH, Ho VNA, Pham TD, Sanchez F, Romero S, De Vos M, Ho TM, Gilchrist RB, Smitz J. Live births after oocyte in vitro maturation with a prematuration step in women with polycystic ovary syndrome. J Assist Reprod Genet. 2020 Feb;37(2):347-357. doi: 10.1007/s10815-019-01677-6. Epub 2020 Jan 4.
PubMed 31902102Sanchez F, Le AH, Ho VNA, Romero S, Van Ranst H, De Vos M, Gilchrist RB, Ho TM, Vuong LN, Smitz J. Biphasic in vitro maturation (CAPA-IVM) specifically improves the developmental capacity of oocytes from small antral follicles. J Assist Reprod Genet. 2019 Oct;36(10):2135-2144. doi: 10.1007/s10815-019-01551-5. Epub 2019 Aug 9.
PubMed 31399916