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

Infertility Clinical Trial

Official title:

Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02772120
• Other study ID #: BWH2016progRCT
• Status: Withdrawn
• Phase: Phase 4

Study information

• Verified date: September 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Percentage of patients with intrauterine gestational sac by ultrasound	5-6 weeks
Secondary	Implantation rate	Maximum number of gestational sacs divided by total number of embryos transferred	5-6 weeks
Secondary	Sustained implantation rate	maximum number of fetal heartbeats divided by total number of embryos transferred	7 weeks
Secondary	Biochemical pregnancy	Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy	6 weeks
Secondary	Ongoing pregnancy rate	Live intrauterine pregnancy at the time of transfer to obstetrical care	7-8 weeks

External Links

•   Drug information for progesterone