Progesterone Support of FET

NCT ID: NCT01058382

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-10-31

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.

Conditions

Frozen Embryo Pregnancy Rate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Progesterone Vaginal Suppositories

Progesterone Vaginal Suppositories

Intervention Type: DRUG

Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer

Intramuscular Progesterone-in-Oil

Intramuscular Progesterone-in-Oil

Intervention Type: DRUG

Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer

Interventions

Progesterone Vaginal Suppositories

Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer

Intervention Type: DRUG

Intramuscular Progesterone-in-Oil

Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Charles Coddington

OTHER

Sponsor Role: lead

Responsible Party

Charles Coddington

Charles C. Coddington MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charles Coddington, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

09-008006

Identifier Type: -

Identifier Source: org_study_id