InfertilityNCT03470610
Administration of Vaginal and Rectal Progesterone During FET Cycles
An observational study of Infertility, run by Thor Haahr at 1 site in Denmark.
Trial summary
Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Progesterone
- How many people
- 277 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2018to 1 Sep 2019
- How long will I take part?
- 4 Months
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Autologuos spare embryos from previous IVF/ICSI cycles.
Who may be able to join
- Frozen embryo transfer cycles in HRT cycles
Who cannot join
- Donor frozen embryo transfer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Vaginal and Rectal Progesterone During Frozen Embryo Transfer Cycles
Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone.
Read the detailed description
Cohort of patients treated with autologous blastocyst at the Fertility clinic Skive Regional Hospital in HRT cycle. Estradiol stimulation started on second cycle day and on day 12 - 20 vaginal and rectal progesterone is added. Blastocyst transfer on 6th progesterone treatment day. Serum progesterone and hCG measurement 9 or 11 days after embryo transfer.
- Conditions
- Infertility
- Being tested
- Progesterone
- Keywords
- Progesterone, HRT, frozen embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called estradiol
6 mg estradiol and vaginal and rectal progesterone
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy
gestational week 12
Measured: 4 month
Secondary outcomes (2)
pregnancy rate
positive hCG
Measured: 4 month
Pregnancy loss
pregnancy loss before week 7
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Feb 2018
- Primary completion1 Feb 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 277 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Thor Haahr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thor Haahr, Regionshospitalet Viborg, Skive
- Investigators
- Peter Humaidan, DMsc, Study chair, Fertility Clinic Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470610
- Sponsor's protocol ID
- Progesterone03
- Status last verified
- Sep 2019
- First submitted
- 12 Mar 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Vaginal and Rectal Progesterone During Frozen Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT03470610
- Acronym / sponsor ID
- Progesterone03
- Conditions
- Infertility
- Keywords
- Progesterone, HRT, frozen embryo transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Thor HaahrUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Mar 2018 (actual)
- 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.
Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone.
Detailed description
Cohort of patients treated with autologous blastocyst at the Fertility clinic Skive Regional Hospital in HRT cycle. Estradiol stimulation started on second cycle day and on day 12 - 20 vaginal and rectal progesterone is added. Blastocyst transfer on 6th progesterone treatment day. Serum progesterone and hCG measurement 9 or 11 days after embryo transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Autologuos spare embryos from previous IVF/ICSI cycles.
Key inclusion criteria (1 listed)
- Frozen embryo transfer cycles in HRT cycles
Key exclusion criteria (1 listed)
- Donor frozen 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 |
|---|---|---|
| ProgesteroneAlso: estradiol6 mg estradiol and vaginal and rectal progesterone | Drug | – |
Primary outcome
ongoing pregnancy
Time frame: 4 month
gestational week 12
2 secondary outcomes
pregnancy rate
Time frame: 4 month
Pregnancy loss
Time frame: 4 month
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 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Peter Humaidan, DMsc study chair
Fertility Clinic Skive
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 Infertility, run by Thor Haahr at 1 site in Denmark.
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 1 inclusion and 1 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 Sep 2019. 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 Denmark. 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?
ongoing pregnancy (time frame: 4 month). 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 Sep 2019.