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

Phase 4

Withdrawn

• Conditions: Infertility
• Interventions: Drug: Vaginal progesterone gel (Crinone® 8%); Drug: Intramuscular Progesterone

• Registration Number: NCT02772120
• Lead Sponsor: 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).

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).

Study Timeline

• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone gel (Crinone® 8%)	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	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.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	5-6 weeks	Percentage of patients with intrauterine gestational sac by ultrasound

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	7-8 weeks	Live intrauterine pregnancy at the time of transfer to obstetrical care
Sustained implantation rate	7 weeks	maximum number of fetal heartbeats divided by total number of embryos transferred
Implantation rate	5-6 weeks	Maximum number of gestational sacs divided by total number of embryos transferred
Biochemical pregnancy	6 weeks	Positive serum b-hCG (above 5 IU/L) without subsequent ultrasound evidence of pregnancy

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States