Luteal Phase DefectCycloCTNCT04722471
Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.
An observational study of Luteal Phase Defect, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Luteal Phase Defect
- What is being tested?
- Vaginally administered progesterone
- Type of treatment
- Pill or oral medicine
- How many people
- 347 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2021to 17 Mar 2021
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The population will be selected among those patients who have undergone embryo transfer treatment with endometrial preparation in a artificial cycle at the Instituto Bernabeu.
Who may be able to join
- Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens.
- Age between 18 and 50 years.
- Normal uterine cavity verified by imaging techniques.
- Serum progesterone documented on the day of embryo transfer.
Who cannot join
- Patients with a history of endometritis.
- Patients diagnosed with Asherman's syndrome.
- Patients with a different supplementation regimen or doses than those of the study groups.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.
This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.
- Conditions
- Luteal Phase Defect
- Being tested
- Vaginally administered progesterone
- Keywords
- Frozen embryo transfer, endometrial preparation, artificial cycle, progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginally administered progesteroneDrug
The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)
| Study group | Role | What they receive |
|---|---|---|
| 400 mg | Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day. Receives: Drug: Vaginally administered progesterone | |
| 200 mg | Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day. Receives: Drug: Vaginally administered progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum progesterone level
Measured: On the day of embryo transfer
Secondary outcomes (2)
Need for additional progesterone supplementation
Measured: assessed on the day of the embryo transfer
Clinical results (ongoing pregnancy and miscarriage rate)
Measured: assessed on the day of the pregnancy test and during the pregnancy evolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start3 Mar 2021
- Primary completion3 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Luteal Phase DefectStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Llácer, Instituto Bernabeu
- Investigators
- Joaquín Llácer, MD PhD, Principal investigator, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722471
- Sponsor's protocol ID
- IB-1201
- Acronym
- CycloCT
- Status last verified
- Mar 2021
- First submitted
- 21 Jan 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information collected in the study will always be treated as grouped data and never as individual or personal data, thus maintaining anonymity and confidentiality.
Publications
Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.
PubMed 29040638Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322.
PubMed 33340402
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.
- ClinicalTrials.gov ID
- NCT04722471
- Acronym / sponsor ID
- CycloCT / IB-1201
- Conditions
- Luteal Phase Defect
- Keywords
- Frozen embryo transfer, endometrial preparation, artificial cycle, progesterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 25 Jan 2021 (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.
This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.
This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 mg | – | Drug: Vaginally administered progesteroneTreatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day. |
| 200 mg | – | Drug: Vaginally administered progesteroneTreatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population will be selected among those patients who have undergone embryo transfer treatment with endometrial preparation in a artificial cycle at the Instituto Bernabeu.
Key inclusion criteria (4 listed)
- Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens.
- Age between 18 and 50 years.
- Normal uterine cavity verified by imaging techniques.
- Serum progesterone documented on the day of embryo transfer.
Key exclusion criteria (3 listed)
- Patients with a history of endometritis.
- Patients diagnosed with Asherman's syndrome.
- Patients with a different supplementation regimen or doses than those of the study groups.
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 |
|---|---|---|
| Vaginally administered progesteroneThe artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day) | Drug | 200 mg, 400 mg |
Primary outcome
Serum progesterone level
Time frame: On the day of embryo transfer
2 secondary outcomes
Need for additional progesterone supplementation
Time frame: assessed on the day of the embryo transfer
Clinical results (ongoing pregnancy and miscarriage rate)
Time frame: assessed on the day of the pregnancy test and during the pregnancy evolution
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 19 Mar 2021.
- Results publication: PubMed 29040638Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.
- Results publication: PubMed 33340402Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322.
- Individual participant dataSharing planned: No. The information collected in the study will always be treated as grouped data and never as individual or personal data, thus maintaining anonymity and confidentiality.
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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.
Joaquín Llácer, MD PhD principal investigator
Instituto Bernabeu
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 Luteal Phase Defect, run by Instituto Bernabeu at 1 site in Spain.
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 3 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 19 Mar 2021. 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 Spain. 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?
Serum progesterone level (time frame: On the day of embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722471, which also lists 2 linked publications.
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 19 Mar 2021.