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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
History of Changes
  Purpose

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 Intervention Phase
Frozen Embryo Pregnancy Rate
 Drug: Progesterone Vaginal Suppositories
Drug: Intramuscular Progesterone-in-Oil
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Progesterone Support for Frozen Embryo Transfer: Intramuscular Versus Vaginal Suppository - A Prospective, Randomized, Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Clinical Pregnancy Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women having a frozen embryo transfer.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058382

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

No publications provided

Responsible Party: Charles Coddington, Charles C. Coddington MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058382     History of Changes
Other Study ID Numbers: 09-008006
Study First Received: January 26, 2010
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
FET
Progesterone Support
Frozen Embryo Transfer

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013