Progesterone Support of FET (FETProg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058382
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : May 10, 2013
Information provided by (Responsible Party):
Charles Coddington, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Frozen Embryo Pregnancy Rate Drug: Progesterone Vaginal Suppositories Drug: Intramuscular Progesterone-in-Oil Phase 4

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Progesterone Support for Frozen Embryo Transfer: Intramuscular Versus Vaginal Suppository - A Prospective, Randomized, Controlled Trial
Study Start Date : February 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Progesterone Vaginal Suppositories Drug: Progesterone Vaginal Suppositories
Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer
Intramuscular Progesterone-in-Oil Drug: Intramuscular Progesterone-in-Oil
Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer

Primary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women having a frozen embryo transfer.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01058382

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Charles Coddington
Principal Investigator: Charles Coddington, MD Mayo Clinic

Responsible Party: Charles Coddington, Charles C. Coddington MD, Mayo Clinic Identifier: NCT01058382     History of Changes
Other Study ID Numbers: 09-008006
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Charles Coddington, Mayo Clinic:
Progesterone Support
Frozen Embryo Transfer

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs