Fertilo In Vitro Research Study and Trial

Inclusion Criteria:

1. Written informed consent.

2. Premenopausal, Age 18-35.

3. Body mass index (BMI) 21-40.

4. Candidate for IVF according to the ASRM definition (infertile for ≥12 months,require the use of donor sperm, or the inability to achieve a successful pregnancybased on a patient's medical, sexual, and reproductive history, age, physicalfindings, diagnostic testing, or any combination of those factors).

5. No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.

6. Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.

7. Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 orassessed at the screening visit.

8. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography orsonohysterography within 12 months of Screening/Visit 1 or assessed at the screeningvisit.

9. Having adequate visualization of both ovaries, without evidence of significantabnormality/pathology or major cyst documented by transvaginal ultrasound within 3months of screening or assessed during screening period.

10. No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence ofendometrioma.

11. Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist orgonadotropins prior to start of ovarian stimulation.

12. Have a male partner with semen analysis within the past 12 months prior torandomization considered adequate to proceed with intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If this criterion is not met,the subject can only be entered if donor sperm will be used.

Exclusion Criteria:

1. History of recurrent pregnancy loss (defined as >2 clinical pregnancies without livebirth).

2. Baseline prolactin levels greater than 30 ng/ml

3. Male: requirement for retrograde ejaculation procedures or surgical spermretrievals.

4. Any clinically relevant pathology that in the judgment of the investigator couldimpair embryo implantation or pregnancy continuation.

5. Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferredblastocysts during participation in the study.

6. Use of donated oocytes, embryos or blastocysts for this treatment cycle whileparticipating in the study or use of oocytes, embryos, or blastocysts from aprevious treatment cycle.

7. Participation in a concurrent clinical trial or in another investigational drugtrial within the past 2 months.