Status:
COMPLETED
Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
Lead Sponsor:
Fertility Centers of Illinois
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
21-49 years
Phase:
PHASE4
Brief 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.
Detailed Description
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01465373
Start Date
February 1 2010
End Date
September 1 2011
Last Update
November 4 2011
Active Locations (1)
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1
Fertility Centers of Illinois
Chicago, Illinois, United States, 60610