Progesterone Support of FET

Completed

• Conditions: Frozen Embryo Pregnancy Rate
• Interventions: Drug: Progesterone Vaginal Suppositories; Drug: Intramuscular Progesterone-in-Oil

• Registration Number: NCT01058382
• Lead Sponsor: Charles Coddington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-02
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Progesterone Vaginal Suppositories	Progesterone Vaginal Suppositories	-
Intramuscular Progesterone-in-Oil	Intramuscular Progesterone-in-Oil	-

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	3 years

Secondary Outcome Measures

Name	Time	Method
Implantation rate	3 years

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States