Frozen Embryo Pregnancy RateFETProgNCT01058382
Progesterone Support of FET
An observational study of Frozen Embryo Pregnancy Rate, run by Charles Coddington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Frozen Embryo Pregnancy Rate
- What is being tested?
- Progesterone Vaginal Suppositories and Intramuscular Progesterone-in-Oil
- Type of treatment
- Injection or infusion
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women having a frozen embryo transfer.
Who may be able to join
- 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
Who cannot join
- Diagnosis of severe medical illness
- Uterine lesions affecting the cavity or endometrium
- Uterine anomaly
- Presence of hydrosalpinx
- Extreme difficulty with embryo transfer
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Frozen Embryo Pregnancy Rate
- Being tested
- Progesterone Vaginal Suppositories, Intramuscular Progesterone-in-Oil
- Keywords
- FET, Progesterone Support, Frozen Embryo Transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone Vaginal SuppositoriesDrug
Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer
Intramuscular Progesterone-in-OilDrug
Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Progesterone Vaginal Suppositories | Not described Receives: Drug: Progesterone Vaginal Suppositories | |
| Intramuscular Progesterone-in-Oil | Not described Receives: Drug: Intramuscular Progesterone-in-Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Measured: 3 years
Secondary outcomes (1)
Implantation rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Embryo Pregnancy RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Coddington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charles Coddington, Mayo Clinic
- Investigators
- Charles Coddington, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058382
- Sponsor's protocol ID
- 09-008006
- Acronym
- FETProg
- Status last verified
- May 2013
- First submitted
- 26 Jan 2010
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Support for Frozen Embryo Transfer: Intramuscular Versus Vaginal Suppository - A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01058382
- Acronym / sponsor ID
- FETProg / 09-008006
- Conditions
- Frozen Embryo Pregnancy Rate
- Keywords
- FET, Progesterone Support, Frozen Embryo Transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Charles CoddingtonUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone Vaginal Suppositories | – | Drug: Progesterone Vaginal Suppositories |
| Intramuscular Progesterone-in-Oil | – | Drug: Intramuscular Progesterone-in-Oil |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women having a frozen embryo transfer.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Diagnosis of severe medical illness
- Uterine lesions affecting the cavity or endometrium
- Uterine anomaly
- Presence of hydrosalpinx
- Extreme difficulty with embryo transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone Vaginal SuppositoriesProgesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer | Drug | Progesterone Vaginal Suppositories |
| Intramuscular Progesterone-in-OilProgesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer | Drug | Intramuscular Progesterone-in-Oil |
Primary outcome
Clinical Pregnancy Rate
Time frame: 3 years
1 secondary outcome
Implantation rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
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Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Coddington, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Embryo Pregnancy Rate, run by Charles Coddington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.