Ongoing Pregnancy RateNCT03272412
Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.
An observational study of Ongoing Pregnancy Rate, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Ongoing Pregnancy Rate
- What is being tested?
- Analysis of serum Progesterone in blood sample
- How many people
- 1,205 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2017to 28 Nov 2018
- 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
- No healthy volunteers
- Adult
Study population: Women who are undergoing IVF treatments with artificial endometrial preparation with hormonal replacement therapy.
Who may be able to join
- Age <50 years old
- Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:
- Embryos in fresh cycle with donated oocytes.
- Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.
- Frozen embryo transfers in cycles with autologous oocytes.
- Endometrial line: >6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
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- Administration of natural micronized progesterone intravaginally (400 mg/12 hours for 5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy week 12.
- Embryo transfer of blastocyst (day 5-6).
- Signed Informed Consent
Who cannot join
- Uterine pathology (submucous o intramural fibroids (>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
- Simultaneous participation in another clinical study.
- Participation in another clinical study before the inclusion in the present study, and which could affect the objectives of the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.
This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone.
- Conditions
- Ongoing Pregnancy Rate
- Being tested
- Analysis of serum Progesterone in blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of serum Progesterone in blood sampleDiagnostic test
Levels of progesterone will be determined on the day of embryo transfer in patients undergoing artificial endometrial preparation cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum Progesterone levels
Serum progesterone levels
Measured: The day of embryo transfer
Ongoing Pregnancies depending on Progesterone levels ranges.
Ultrasound to confirm Ongoing Pregnancy
Measured: Week 5-12 after Embryo Transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start8 Sep 2017
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ongoing 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
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Labarta, Instituto Valenciano de Infertilidad, IVI VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272412
- Sponsor's protocol ID
- 1704-VLC-024-EL
- Status last verified
- Jan 2019
- First submitted
- 31 Aug 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labarta 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 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.
- ClinicalTrials.gov ID
- NCT03272412
- Acronym / sponsor ID
- 1704-VLC-024-EL
- Conditions
- Ongoing Pregnancy Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 5 Sep 2017 (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 analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who are undergoing IVF treatments with artificial endometrial preparation with hormonal replacement therapy.
Key inclusion criteria (9 listed)
- Age <50 years old
- Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:
- Endometrial line: >6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
- Administration of natural micronized progesterone intravaginally (400 mg/12 hours for 5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy week 12.
- Embryo transfer of blastocyst (day 5-6).
Key exclusion criteria (3 listed)
- Uterine pathology (submucous o intramural fibroids (>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
- Simultaneous participation in another clinical study.
- Participation in another clinical study before the inclusion in the present study, and which could affect the objectives of the present study.
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 |
|---|---|---|
| Analysis of serum Progesterone in blood sampleLevels of progesterone will be determined on the day of embryo transfer in patients undergoing artificial endometrial preparation cycles. | Diagnostic test | – |
Primary outcome
Concentration of serum Progesterone levels
Time frame: The day of embryo transfer
Serum progesterone levels
Ongoing Pregnancies depending on Progesterone levels ranges.
Time frame: Week 5-12 after Embryo Transfer
Ultrasound to confirm Ongoing Pregnancy
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 31 Jan 2019.
- Derived from this study: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ongoing Pregnancy Rate, run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 9 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 31 Jan 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 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?
Concentration of serum Progesterone levels (time frame: The day of embryo transfer). The study lists 2 primary outcomes in all. 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 NCT03272412, which also lists 1 linked publication.
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 31 Jan 2019.