Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.

Exclusion Criteria

• •Persistent (for \>1 cycle), clinically relevant (per PI discretion) ovarian cystic lesion (≥20 mm), including ovarian endometrioma or dermoid cyst.
• •Participants with hepatic impairment (liver function tests \> 2x upper limit of normal). Participants with renal impairment (estimated creatinine clearance \<60 mL/min/1.73 m2).
• •Uncontrolled adrenal, thyroid dysfunction or uncontrolled diabetes (HbA1C \>7% within 3 months from screening).
• •Greater than one IVF cycle canceled due to inability to meet ovulation trigger criteria (i.e. at least 2-3 follicles reach ≥18 mm.).
• •History of recurrent implantation failure (RIF), defined according to the Lugano Consensus as the absence of implantation after transfer of ≥4 good-quality embryos in ≥3 embryo transfer (ET) cycles in women under the age of 40, using autologous oocytes.
• •Recurrent pregnancy loss (RPL) is defined by two or more miscarriages; that is clinical pregnancies with the same partner and documented by ultrasonography or histopathological examination.
• •Known history of anovulation.
• •Antral Follicle Count (AFC) \<5 at screening.
• •One or more dominant follicles (≥11 mm) observed on TVUS prior to randomization on stimulation day 1 with evidence of functional activity defined as serum Estradiol level \>100 pg/ml.
• •Past or current history of an estrogen dependent malignancy
• •Untreated atypical endometrial hyperplasia
• •Any contraindication to the use of oral contraceptives
• •History of OHSS.
• •Morphological sperm evidence of globozoospermia or prior failed oocyte fertilization in previous IVF cycle.
• •The use of donor sperm back up or rescue for fertilization of oocytes.
• •Use of calcium ionophore or treatment of sperm with methyl xanthines.
• •The need for surgically retrieved sperm (i.e. testicular sperm extraction \[TESE\], Percutaneous Epididymal Sperm Aspiration \[PESA\]).
• •Use of any investigational drug throughout the study, or within 3 months before screening or 5 half-lives whichever is longer.
• •Use of any concomitant medications that would interfere with the study drug and with the evaluation of the study (e.g., hormonal medications or other medications affecting reproductive function), as determined by the investigator, unless permitted by the protocol or meeting required washout criteria.
• •Current use or dependence on psychotropic medications that are contraindicated during pregnancy or have known or suspected fetal risk, unless the Investigator determines that the potential benefit outweighs the risk.
• •Required chronic use of non-steroidal anti-inflammatory drugs during cycle.
• •Treatment with clomiphene citrate, metformin, cabergoline, gonadotropins, or GnRH analogs within 1 month prior to randomization.
• •Pregnancy, lactation, or contraindication to gonadotropins.
• •Known thrombophilia or history of blood clots unless fully evaluated and cleared by a hematologist and receiving appropriate prophylaxis.
• •Known abnormal karyotype in the patient or her partner that is considered clinically significant, such as numerical or structural chromosomal abnormalities (e.g., translocations, inversions, aneuploidies) known to impair fertility, increase risk of miscarriage, or result in genetic disorders in offspring.
• •Current tobacco or marijuana user.
• •Current or past (last 12 months) abuse of alcohol or drugs.
• •Current use of dietary supplements containing high dose of biotin (\>300µg), if prior use washout period of 1 week prior to randomization.
• •No use of bioidentical hormones during stimulation or up to three months prior to start of stimulation. If prior use: washout period of three months prior to being randomized.
• •A history of chemotherapy or radiotherapy.
• •Undiagnosed uterine bleeding.
• •Tumors of the ovary, breast, adrenal gland, pituitary, or hypothalamus; malformation of sexual organs incompatible with pregnancy.
• •Known active pelvic inflammatory disease.
• •Current, untreated submucosal fibroids or Intramural fibroids ≥5 cm or otherwise clinically relevant pathology that could impair embryo implantation or pregnancy continuation.
• •The presence of severe endometriosis (ASRM stage 3 or stage 4) confirmed by laparoscopy, Magnetic Resonance Imaging (MRI), or pelvic ultrasound.
• •Concomitant participation in another study protocol.
• •Couples identified as carriers of the same autosomal recessive genetic condition associated with serious health outcomes in offspring will be excluded from the trial.
• •Planned use of a gestational carrier.