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

NCT02772120 | Withdrawn Phase 4 DMC

• 1 other identifier: BWH2016progRCT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility

Keywords

Infertility; In vitro fertilization; Embryo transfer; Blastocyst; Progesterone; Crinone

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Percentage of patients with intrauterine gestational sac by ultrasound

  5-6 weeks

Secondary Outcomes (4)

• Implantation rate

  5-6 weeks

• Sustained implantation rate

  7 weeks

• Biochemical pregnancy

  6 weeks

• Ongoing pregnancy rate

  7-8 weeks

Study Arms (2)

Vaginal progesterone gel (Crinone® 8%)

ACTIVE COMPARATOR

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%)

Intramuscular Progesterone

ACTIVE COMPARATOR

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

Interventions

Vaginal progesterone gel (Crinone® 8%) DRUG

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.

Also known as: vaginal progesterone, Crinone

Vaginal progesterone gel (Crinone® 8%)

Intramuscular Progesterone DRUG

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.

Also known as: progesterone

Intramuscular Progesterone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 26222435 BACKGROUND

• 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.

  PMID: 10527993 BACKGROUND

• 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.

  PMID: 24847018 BACKGROUND

• 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.

  PMID: 22310935 BACKGROUND

Related Links

• Drug information for progesterone

MeSH Terms

Conditions

Infertility

Interventions

Crinone; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Elena Yanushpolsky, MD

  Assistant Professor, Harvard Medical School, Director of Reproductive Surgery at Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 13, 2016
• Primary Completion: September 1, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)