Assisted Reproduction Technologies, Infertility, In Vitro Maturation of Oocytes
Conditions
Keywords
Fertility treatment, Assisted Reproductive Technology, Infertility
Brief summary
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.
Detailed description
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.
Interventions
DEVICECAPA-IVM
CAPA-IVM is a two-step IVM process to mature oocytes in the laboratory after egg retrieval.
Sponsors
Inception Fertility Research Institute, LLC
Lavima Fertility
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will receive the same treatment protocol
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metaphase II rate | Assessed approximately 40 hours after egg retrieval | The metaphase II (MII) rate is defined as the number of oocytes that reach MII stage of development divided by the number of cumulus-oocyte-complexes (COCs) placed into CAPA-IVM culture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocytes | Assessed approximately 40 hours post egg retrieval | The number of oocytes that reach the metaphase II (MII) stage of development after CAPA-IVM culture |
| Fertilization rate | Assessed 16-18 hours post fertilization | The fertilization rate is defined as the number of embryos that have 2 pro-nuclei post fertilization by intracytoplasmic sperm injection (ICSI) |
| Number of blastocysts | Assessed 5-7 days post fertilization | The number of embryos that make it to the blastocyst stage of development post fertilization |
| Number of blastocysts vitrified | Assessed 5-7 days post fertilization | The number of embryos that are cryopreserved by vitrification post fertilization |
| Number of blastocysts submitted for PGT-A | Assessed 5-7 days post fertilization | The number of embryos that are biopsied and samples sent for PGT-A testing |
| Number of euploid blastocysts | Assessed 2-4 weeks post embryo biopsy | Number of embryos that had a euploid result from PGT-A testing |
| Positive beta-hCG rate | Assessed 9-11 days post embryo transfer | The number of patients with a serum QHCG level greater than 5 after embryo transfer divided by the total number of embryo transfers |
| Ongoing pregnancy rate | Assessed approximately 10 weeks post embryo transfer | The number of patients who have an ongoing intrauterine pregnancy at the last study visit |
| Live birth rate | Assessed approximately 40 weeks post embryo transfer | Number of patients who had a live birth after embryo transfer |
Countries
United States
Outcome results
None listed