Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs

Comparison of the Effectiveness of Micronized Vaginal Progesterone (Endometrin, Ferring) Vs. Progesterone in Oil for Luteal Phase Support in Donor Egg Recipient IVF Cycles Utilizing Previously Vitrified Donor Oocytes

The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.

The primary objective of this study is to evaluate the clinical pregnancy rate of micronized progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification will be evaluated by egg thaw/survival, fertilization, and implantation rates.

Inclusion Criteria:

Oocyte Donors:

• Age 21-34 years of age
• BMI 18-34
• Normal ovarian reserve, defined as FSH <10 and AFC >10
• Medical evaluation consistent with FDA criteria for donor inclusion

Donor Oocyte Recipients

• Documented history of infertility requiring donor oocyte for optimal fertility potential
• Documentation of a normal uterine cavity by hysteroscopy, hysterosonogram, or HSG within 1 year of study screening
• Fresh or Frozen Sperm

Exclusion Criteria:

Oocyte Donors:

• Abnormal ovarian reserve, defined as FSH <10, AFC>10, prior poor response to controlled ovarian hyper-stimulation(COHS)
• Failure to meet FDA criteria for donor approval (risk factor and medical evaluation)
• Previous history of poor response to COHS

Donor Oocyte Recipients:

• Uncontrolled hypothyroidism, hyperprolactinemia, or systemic disease that may interfere with study treatment
• Active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders
• Surgically aspirated sperm (TESE)
• 2 or more clinical pregnancy losses (excluding aneuploidy for previous autologous cycles)
• Clinically significant gynecologic pathology or uterine abnormality, such as submucosal fibroids > 5 cm, communicating hydrosalpinx, uncorrected uterine septum, undiagnosed vaginal bleeding, endometrial atypia, or any other condition that could adversely affect pregnancy outcomes
• History of 2 or more failed IVF donor cycles