Progesterone Support of FET (FETProg)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charles Coddington, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01058382
First received: January 26, 2010
Last updated: May 8, 2013
Last verified: May 2013

January 26, 2010
May 8, 2013
February 2010
October 2012   (final data collection date for primary outcome measure)
Clinical Pregnancy Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058382 on ClinicalTrials.gov Archive Site
Implantation rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Progesterone Support of FET
Progesterone Support for Frozen Embryo Transfer: Intramuscular Versus Vaginal Suppository - A Prospective, Randomized, Controlled Trial

There have been two very common forms of progesterone administration that have been used during ovulation induction, in vitro fertilization (IVF) and embryo transfers. There are currently no randomized clinical trials to demonstrate which method of progesterone administration is more effective for frozen embryo transfer. We raise the question: Is there a difference between the two accepted methods of progesterone administration, intramuscular and vaginal suppositories, for frozen embryo transfer? Studies for fresh embryo transfer after in vitro fertilization, have demonstrated that there is not a difference between the two methods of progesterone administration. We will evaluate the question for frozen embryo transfer.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Women having a frozen embryo transfer.

Frozen Embryo Pregnancy Rate
  • Drug: Progesterone Vaginal Suppositories
    Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer
  • Drug: Intramuscular Progesterone-in-Oil
    Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer
  • Progesterone Vaginal Suppositories
    Intervention: Drug: Progesterone Vaginal Suppositories
  • Intramuscular Progesterone-in-Oil
    Intervention: Drug: Intramuscular Progesterone-in-Oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females < 50 years of age
  • Having frozen embryo transfer at Mayo Clinic
  • Embryos have been created prior to age 42
  • Willing to be randomized to either method of progesterone administration

Exclusion Criteria:

  • Diagnosis of severe medical illness
  • Uterine lesions affecting the cavity or endometrium
  • Uterine anomaly
  • Presence of hydrosalpinx
  • Extreme difficulty with embryo transfer
Female
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058382
09-008006
No
Charles Coddington, Mayo Clinic
Charles Coddington
Not Provided
Principal Investigator: Charles Coddington, MD Mayo Clinic
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP