Aspire In Vitro Maturation Study

CAPA-IVM is being evaluated for its feasibility as an In vitro maturation (IVM) system in US fertility clinics. IVM is a laboratory process for maturing immature oocytes (eggs) outside of the body after egg retrieval. Egg retrievals are performed without prior ovarian stimulation.

Inclusion criteria

• Signed Informed Consent Form to participate in this study voluntarily.
• Age 18-37 years at the time of starting the CAPA-IVM cycle.
• Body mass index (BMI) ≤38 kg/m2.
• Serum AMH levels greater than or equal to 3.5 ng/mL.
• Have an indication for IVM/IVF cycle.
• Have not received more than two previous treatments of IVM/IVF.
• Willing and able to comply with trial procedures, including oocyte pick-up from small follicles and to follow a CAPA-IVM cycle.
• Agree to culture all embryos to blastocyst stage, vitrify suitable blastocysts, and submit suitable blastocysts for PGT-A according to clinic protocol before determining transfer eligibility.
• Agree that only euploid CAPA-IVM-derived blastocysts will be eligible for transfer and that a single euploid blastocyst will be transferred per programmed FET cycle, unless a protocol-defined exception is prospectively justified by the investigator.

Exclusion criteria

• Prior ovarian surgery.
• Known uterine abnormalities (adenomyosis, leiomyoma (≥5 cm), bicornuate uterus, intrauterine adhesion) that would compromise successful pregnancy or live birth.
• Had received ovarian stimulation within the last 3 months for ovulation induction or IVF
• Had evidence of a very low oocyte maturation rate (oocyte maturation rate < 50% in any previous IVF or IVM cycle).
• For male partners: severe oligoasthenoteratozoospermia, requirement for retrograde ejaculation procedures or surgical sperm retrievals. Donor sperm is permitted.
• Known chromosomal abnormalities in participant or partner.
• Have herself or partner with acute urinary tract infection or sexually transmitted diseases.
• Have herself or partner a severe mental disorder, such as schizophrenia, bipolar affective disorder, or intellectual disability caused by mental disorders.
• Have a history of recurrent pregnancy loss defined as two or more clinical pregnancies without live birth.
• Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus that would preclude to conduct a CAPA-IVM cycle without ovarian stimulation or participation in this study.
• Any known clinically significant systemic disease (heart, liver, kidney or other organs) that would prevent or compromise pregnancy or participation in this study.
• Pregnancy or contraindication to pregnancy.
• Undiagnosed vaginal bleeding.
• Known drug or alcohol abuse or dependency for the participant or partner for the last 12 months.
• Current or past (3 months) smoking habit of 10 or more cigarettes per day.
• Had a recent exposure to teratogenic radiation, drugs or toxins which could still be active during the study period.
• Currently participating in another clinical trial or receiving an investigational medicinal product.
• Previous participation in this study.