Evaluation of the safety of ovarian support cell in vitro maturation (OSC-IVM) application during in vitro fertilization procedures for infertility treatment

Not Applicable

• Conditions: Treatment of infertility via in vitro fertilization (IVF) treatment; Pregnancy and Childbirth

• Registration Number: ISRCTN36032472
• Lead Sponsor: Gameto Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-31
• Last Update Posted: 13 November 2023
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 20

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, 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) and total testosterone.
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

Exclusion Criteria

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 substance abuse, including alcohol abuse
12. Abnormal, undiagnosed vaginal bleeding at the time of screening
13. Abnormal serum iron, HbA1c, prolactin, Hb levels
14. Any medical or surgical condition that in the Investigator’s judgment renders a subject unsuitable for study participation
15. Inability to comply with study procedures
16. Condition that requires PGT-M or PGT-SR
17. Male partner/sperm donor: Known or positive test for high DNA fragmentation in sperm
18. Male partner/sperm donor: requirement for retrograde ejaculation procedures or surgical sperm retrievals

Study & Design

• Study Type: Observational
• Study Design: Not specified