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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fertility Centers of Illinois
• Collaborator: Ferring Pharmaceuticals
• Treatments: Progesterone

Criteria

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