Health TrialsbyHealthPanel

Intra-ovarian CAPA-IVM vs Standard IVM

ConditionsInfertility (IVF Patients)InfertilityInfertility Female
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorNew Hope Fertility Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • CAPA-IVM

    Procedure/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 Medium

    Device

    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-IVF

    Procedure/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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Within-Patient CAPA-IVM and Minimal-Stimulation OS-IVFExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to approximately 54 hours after initiation of CAPA-IVM culture

Secondary outcomes

1

Fertilization Rate

Proportion of injected MII oocytes showing normal two-pronuclear (2PN) fertilization after ICSI, analyzed by ovary/treatment origin.

Time frame
At fertilization assessment following ICSI
2

Cleavage Rate

Proportion of normally fertilized embryos that undergo cleavage by embryo culture Day 2-3.

Time frame
Day 2-3 after fertilization
3

Blastocyst Formation Rate

Proportion of embryos developing to the blastocyst stage, analyzed according to CAPA-IVM or minimal-stimulation OS-IVF origin.

Time frame
Day 5-6 after fertilization
4

High-Quality Blastocyst Rate

Proportion of embryos meeting the center's predefined criteria for high-quality blastocyst morphology.

Time frame
Day 5-6 after fertilization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New Hope Fertility Center

Lead sponsor

Embryotools

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: