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Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles

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ClinicalTrials.gov Identifier: NCT02772120
Recruitment Status : Withdrawn (Before enrollment, suspended due to changing insurance coverage of study drugs.)
First Posted : May 13, 2016
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Hesina Yanushpolsky, MD, Brigham and Women's Hospital

Brief Summary:
The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).

Condition or disease Intervention/treatment Phase
Infertility Drug: Vaginal progesterone gel (Crinone® 8%) Drug: Intramuscular Progesterone Phase 4

Detailed Description:
The hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vaginal progesterone gel (Crinone® 8%)
Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.
Drug: Vaginal progesterone gel (Crinone® 8%)
Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.
Other Names:
  • vaginal progesterone
  • Crinone

Active Comparator: Intramuscular Progesterone
Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.
Drug: Intramuscular Progesterone
Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.
Other Name: progesterone




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 5-6 weeks ]
    Percentage of patients with intrauterine gestational sac by ultrasound


Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: 5-6 weeks ]
    Maximum number of gestational sacs divided by total number of embryos transferred

  2. Sustained implantation rate [ Time Frame: 7 weeks ]
    maximum number of fetal heartbeats divided by total number of embryos transferred

  3. Biochemical pregnancy [ Time Frame: 6 weeks ]
    Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy

  4. Ongoing pregnancy rate [ Time Frame: 7-8 weeks ]
    Live intrauterine pregnancy at the time of transfer to obstetrical care



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Patient age at time of embryo freezing: 18 to 40.9 years
  • Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)
  • Blastocysts frozen by vitrification at Brigham and Women's Hospital
  • Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital

Exclusion Criteria:

  • Fresh or cleavage-stage embryo transfer planned
  • Gestational carrier cycles
  • Natural and modified natural cycles
  • Embryos frozen more than once or derived from thawed oocytes
  • Embryos frozen at centers other than Brigham and Women's Hospital
  • Embryos frozen using techniques other than vitrification (i.e. slow frozen)
  • Patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies
  • Uterine factor infertility: Asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx
  • Patients with three prior failed embryo transfers (fresh or frozen)
  • BMI<18 or >40 kg/m2 at screening
  • Currently breast feeding or pregnant
  • Embryo biopsy performed
  • Current smoking, alcohol or illicit drug use
  • Allergy to study drugs
  • Refusal or inability to adhere to study protocol
  • Participation in other experimental drug trials concurrently within the past 60 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772120


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Elena Yanushpolsky, MD Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital
Additional Information:
Publications:
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Responsible Party: Elena Hesina Yanushpolsky, MD, Assistant Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02772120    
Other Study ID Numbers: BWH2016progRCT
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elena Hesina Yanushpolsky, MD, Brigham and Women's Hospital:
Infertility
In vitro fertilization
Embryo transfer
Blastocyst
Progesterone
Crinone
Additional relevant MeSH terms:
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Infertility
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs