Trial | NCT01465373  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    progesterone ...

  • Study Participants

    10
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.
Study Started
Feb 28
2010
Primary Completion
Sep 30
2011
Study Completion
Sep 30
2011
Last Update
Nov 04
2011
Estimate

Drug Endometrin

100 mg per vagina TID

Drug Progesterone in Oil

50 mg IM injection daily

Progesterone in Oil Active Comparator

Donor egg recipients will begin progesterone 50 mg IM injection starting the day after donor egg fertilization, and continue daily until pregnancy results can be determined. If pregnant, donor egg recipient will continue progesterone 50 mg IM injections daily until approximately 9 weeks of pregnancy.

Endometrin Active Comparator

Donor egg recipients will begin Endometrin 100 mg per vagina three times daily starting the day after donor egg fertilization and continue until pregnancy result can be determined. If pregnant, donor egg recipients will continue Endometrin 100 mg TID until approximately 9 weeks of pregnancy.

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
No Results Posted