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

Primary Purpose

Infertility

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vaginal progesterone gel (Crinone® 8%)
Intramuscular Progesterone
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, In vitro fertilization, Embryo transfer, Blastocyst, Progesterone, Crinone

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vaginal progesterone gel (Crinone® 8%)

Intramuscular Progesterone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Percentage of patients with intrauterine gestational sac by ultrasound

Secondary Outcome Measures

Implantation rate
Maximum number of gestational sacs divided by total number of embryos transferred
Sustained implantation rate
maximum number of fetal heartbeats divided by total number of embryos transferred
Biochemical pregnancy
Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy
Ongoing pregnancy rate
Live intrauterine pregnancy at the time of transfer to obstetrical care

Full Information

First Posted
May 11, 2016
Last Updated
September 6, 2019
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02772120
Brief Title
Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles
Official Title
Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Before enrollment, suspended due to changing insurance coverage of study drugs.
Study Start Date
undefined (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, In vitro fertilization, Embryo transfer, Blastocyst, Progesterone, Crinone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal progesterone gel (Crinone® 8%)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intramuscular Progesterone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vaginal progesterone gel (Crinone® 8%)
Other Intervention Name(s)
vaginal progesterone, Crinone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intramuscular Progesterone
Other Intervention Name(s)
progesterone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Percentage of patients with intrauterine gestational sac by ultrasound
Time Frame
5-6 weeks
Secondary Outcome Measure Information:
Title
Implantation rate
Description
Maximum number of gestational sacs divided by total number of embryos transferred
Time Frame
5-6 weeks
Title
Sustained implantation rate
Description
maximum number of fetal heartbeats divided by total number of embryos transferred
Time Frame
7 weeks
Title
Biochemical pregnancy
Description
Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy
Time Frame
6 weeks
Title
Ongoing pregnancy rate
Description
Live intrauterine pregnancy at the time of transfer to obstetrical care
Time Frame
7-8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Yanushpolsky, MD
Organizational Affiliation
Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26222435
Citation
Wang Y, He Y, Zhao X, Ji X, Hong Y, Wang Y, Zhu Q, Xu B, Sun Y. Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population. PLoS One. 2015 Jul 29;10(7):e0133027. doi: 10.1371/journal.pone.0133027. eCollection 2015.
Results Reference
background
PubMed Identifier
10527993
Citation
Lightman A, Kol S, Itskovitz-Eldor J. A prospective randomized study comparing intramuscular with intravaginal natural progesterone in programmed thaw cycles. Hum Reprod. 1999 Oct;14(10):2596-9. doi: 10.1093/humrep/14.10.2596.
Results Reference
background
PubMed Identifier
24847018
Citation
Shapiro DB, Pappadakis JA, Ellsworth NM, Hait HI, Nagy ZP. Progesterone replacement with vaginal gel versus i.m. injection: cycle and pregnancy outcomes in IVF patients receiving vitrified blastocysts. Hum Reprod. 2014 Aug;29(8):1706-11. doi: 10.1093/humrep/deu121. Epub 2014 May 20.
Results Reference
background
PubMed Identifier
22310935
Citation
Berger BM, Phillips JA. Pregnancy outcomes in oocyte donation recipients: vaginal gel versus intramuscular injection progesterone replacement. J Assist Reprod Genet. 2012 Mar;29(3):237-42. doi: 10.1007/s10815-011-9691-9. Epub 2012 Feb 4.
Results Reference
background
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/name/Progesterone
Description
Drug information for progesterone

Learn more about this trial

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

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