Clinical trial NCT02772120: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Keywords: Infertility
In vitro fertilization
Embryo transfer
Blastocyst
Progesterone
Crinone
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 5-6 weeks
Secondary outcomes:
measure: Implantation rate
timeFrame: 5-6 weeks
measure: Sustained implantation rate
timeFrame: 7 weeks
measure: Biochemical pregnancy
timeFrame: 6 weeks
measure: Ongoing pregnancy rate
timeFrame: 7-8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital
name: Elena Yanushpolsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.