Treatment of infertility via in vitro fertilization (IVF) treatment Pregnancy and Childbirth
Conditions
Interventions
Current interventions as of 28/02/2025:
The cohort selected for observation will undergo ovarian support cell in vitro maturation (OSC-IVM) application, using the product Fertilo, on immature oocytes
Sponsors
Gameto Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 18/06/2025: 1. Written informed consent 2. Premenopausal, age 18-37 years at the time of providing informed consent, who is an appropriate candidate for IVF 3. Hormone levels within 6 months of consent: anti-mullerian hormone (AMH) level = 2 ng/ml, follicle stimulating hormone (FSH) level on cycle day 2 or 3 < 10 mIU/ml, estradiol (E2) on cycle day 2 or 3 <70pg/ml 4. Body Mass Index (BMI) of 21-30 kg/m² 5. Antral Follicle Count = 20 6. No evidence of hormonal disorders as determined by measurements of thyroid stimulating hormone (TSH), prolactin (PRL), sex hormone binding globulin (SHBG). 7. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 2 months of screening 8. Negative and up to date cervical cancer screening. All those positive for high-risk human papillomavirus must be negative on subsequent cytology. 9. Presence of both ovaries with no major obstructions (ovarian fibroids, ovarian cysts, endometriosis) 10. Plan to use one of the resultant embryos within 2 months of egg retrieval 11. Willing and able to take contraceptives 12. Male partner/sperm donor: age of 21-45 years 13. Male partner/sperm donor:t: provide ejaculated sperm with a normal semen analysis with: Volume(=1,4 ml), Sperm Count (concentration) (=16 M/ml), Motility (=30%), Morphology (=4% Strict Morphology), Vitality (=54%) 14. Consent to a study that involves low doses or no doses of gonadotropins followed by retrieval of immature oocytes 15. Willing to have embryos subjected to PGT-A testing _____ Previous inclusion criteria as of 28/02/2025: 1. Written informed consent 2. Premenopausal, age 20-37 years at the time of providing informed consent, who is an appropriate candidate for IVF 3. Hormone levels within 6 months of consent: anti-mullerian hormone (AMH) level = 2 ng/ml, follicle stimulating hormone (FSH) level on cycle day 2 or 3 < 10 mIU/ml, estradiol (E2) on cycle day 2 or 3 <70pg/ml 4. Body Mass Index (BMI) of 21-30 kg/m² 5. Antral Follicle Count = 20 6. No evidence of hormonal disorders as determined by measurements of thyroid stimulating hormone (TSH), prolactin (PRL), sex hormone binding globulin (SHBG). 7. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 2 months of screening 8. Negative and up to date cervical cancer screening. All those positive for high-risk human papillomavirus must be negative on subsequent cytology. 9. Presence of both ovaries with no major obstructions (ovarian fibroids, ovarian cysts, endometriosis) 10. Plan to use one of the resultant embryos within 2 months of egg retrieval 11. Willing and able to take contraceptives 12. Male partner/sperm donor: age of 21-45 years 13. Male partner/sperm donor:t: provide ejaculated sperm with a normal semen analysis with: Volume(=1,4 ml), Sperm Count (concentration) (=16 M/ml), Motility (=30%), Morphology (=4% Strict Morphology), Vitality (=54%) 14. Consent to a study that involves low doses or no doses of gonadotropins followed by retrieval of immature oocytes 15. Willing to have embryos subjected to PGT-A testing _____ Previous inclusion criteria: 1. Written informed consent 2. Premenopausal, age 25-35 years at the time of providing informed consent, who is an appropriate candidate for IVF 3. Hormone levels within 6 months of consent: anti-mullerian hormone (AMH) level = 2 ng/ml, follicle stimulating hormone (FSH) level on cycle day 2 or 3 < 10 mIU/ml,
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/02/2025: 1. Recurrent pregnancy loss (defined as = 2 clinical pregnancies without live birth) 2. AMH 6 ng/ml or < 2 ng/ml 3. Clinically diagnosed PCOS as defined by the presence of at least two of the following: Oligo- or anovulation, clinical and/or biochemical signs of hyperandrogenism, Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen secreting tumors, Cushing’s syndrome) 4. Contraindications to being pregnant or to any of the IVF hormonal medications to be used in this study 5. Presence of uterine anomaly: mullerian defect (septum, didelphic uterus, bicornuate uterus, unicornuate uterus, arcuate uterus); presence of ?broid(s) affecting the endometrium (myoma, leiomyoma); history of thin endometrium (will not become thicker than 6.9 mm with treatment using exogenous gonadotropins and/or exogenous estrogen); asherman syndrome (intrauterine adhesions) 6. Currently taking: lithium, opioids, and/or thyroid medications (other than for treatment of subclinical hypothyroidism) or other known teratogenic medications 7. Participation in another investigational drug/device trial within previous 30 days of enrollment, or 5 half-lives of the investigational drug, whichever is longer; or planning to participate in an investigational drug/device trial within 30 days of study completion. 8. Greater than 2 previous failed IVF attempts 9. Known history of oocyte maturation defect or cleavage arrest defect 10. Tobacco or nicotine use in the past 12 months 11. History of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Live Birth Rate, measured as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count). | — |
Secondary
| Measure | Time frame |
|---|---|
| IVM and Embryo Outcomes 1. Number of COCs retrieved: Defined as the number of COCs containing an oocyte at the time of retrieval. 2. MII formation: A Metaphase II (MII) oocyte is defined as an oocyte with a first polar body (PB1). 3. Fertilization: Fertilization is assessed 16 to 18 hours after ICSI by assessment of pronuclei formation. The presence of 2 pronuclei and two polar bodies is considered normally fertilized. Embryos with 1 pronuclei or more than 2 pronuclei will be kept for evaluation, as timing and fragmentation/vacuoles can affect pronuclei visualization without deleterious effect on embryo formation. Embryos with zero pronuclei are considered failed to fertilize. 4. Embryo cleavage: Cleavage is assessed on day 3 post-ICSI. Embryos with the presence of 2 or more cells are considered to be cleaved. Fertilized embryos displaying a single cell will be considered not cleaved. 5. Blastocyst formation: Blastocyst formation is assessed at day 5, 6 and 7 post-ICSI. Embryos that have successfully passed the morula stage, as indicated by cavitation, will be designated as blastocysts. 6. Euploid blastocyst formation rate: Euploid embryos are determined by PGT-A analysis of trophectoderm biopsies showing no evidence of chromosomal or segmental aneuploidy. The PGT-A laboratory will use next generation sequencing (NGS) with thresholds set to distinguish two categories: euploid vs. aneuploid blastocysts. Low level mosaicism will not be counted as aneuploid. 7. Blastocyst quality scores: Quality scores are recorded at the time of assessment for biopsy and vitrification either on Day 5, 6 or 7 post-ICSI. Qualitatively assessed as a score for each individual embryo according to the Gardner Scale. Blastocyst quality scores are assessed individually for each biopsied/vitrified blastocyst. 8. Vitrified blastocyst number: Vitrified blastocyst number is determined when blastocysts are vitrified as the number of blastocysts vitrified per patient. Pregnancy Outcomes | — |
Countries
Mexico, Peru
Contacts
Public ContactLuis Guzman
Outcome results
None listed