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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois
ClinicalTrials.gov Identifier:
NCT01465373
First received: May 5, 2010
Last updated: November 2, 2011
Last verified: November 2011
History of Changes

May 5, 2010
November 2, 2011
February 2010
September 2011   (final data collection date for primary outcome measure)
Clinical pregnancy rate of micronized vaginal progesterone (Endometrin, Ferring Pharmaceuticals) compared to intramuscular progesterone supplementation for luteal phase support after IVF-ET from previously vitrified donor eggs [ Time Frame: 10-12 days post IVF-ET ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465373 on ClinicalTrials.gov Archive Site
Evaluation of the effectiveness of vitrification of IVF donor oocytes. Effectiveness will be evaluated by ooctye thaw/survival rates, fertilization and implantation rates assessed from the day of oocyte thawing through IVF cycle outcome. [ Time Frame: six to eight weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Drug: Endometrin
    100 mg per vagina TID
  • Drug: Progesterone in Oil
    50 mg IM injection daily
  • Active Comparator: Progesterone in Oil

    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.

    Intervention: Drug: Progesterone in Oil
  • Active Comparator: Endometrin

    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.

    Intervention: Drug: Endometrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
21 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01465373
10-019
No
Sue Jasulaitis, RN MS Clinical Research Coordinator, Fertility Centers of Illinois
Fertility Centers of Illinois
Ferring Pharmaceuticals
Principal Investigator: Angeline Beltsos, MD Fertility Centers of Illinois
Fertility Centers of Illinois
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP