Aspire In Vitro Maturation Study

Pilot Study Assessing the Feasibility of CAPA-IVM in Participants With Good Ovarian Reserve

A study to assess the Capacitation - in-vitro maturation (CAPA-IVM) system as an option for patients with a good ovarian reserve to achieve pregnancy.

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:

1. Signed Informed Consent Form to participate in this study voluntarily.
2. Age 18-37 years at the time of starting the CAPA-IVM cycle.
3. Body mass index (BMI) ≤38 kg/m2.
4. Serum AMH levels greater than or equal to 3.5 ng/mL.
5. Have an indication for IVM/IVF cycle.
6. Have not received more than two previous treatments of IVM/IVF.
7. Willing and able to comply with trial procedures, including oocyte pick-up from small follicles and to follow a CAPA-IVM cycle.
8. 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.
9. 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:

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