Controlled Ovarian StimulationNCT03366025
Progesterone Variation on the Final Day of Oocyte Maturation.
An observational study of Controlled Ovarian Stimulation and Progesterone Variation on Trigger Day, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Controlled Ovarian Stimulation, Progesterone Variation on Trigger Day, Circadian Rhythm
- What is being tested?
- Serum progesterone measure
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 25 Jan 2018
- How long will I take part?
- 1 Day
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy oocyte donors according to spanish law for oocyte donation
Who may be able to join
- Healthy oocyte donors according to spanish law for oocyte donation
- Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone.
- Informed consent signed
Who cannot join
- Detection of luteinizing hormone surge before triggering
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progesterone Variation on the Final Day of Oocyte Maturation. A Prospective Cohort Study With Repeated Measurements
The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.
- Conditions
- Controlled Ovarian Stimulation, Progesterone Variation on Trigger Day, Circadian Rhythm, Oocyte Donors
- Being tested
- Serum progesterone measure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum progesterone measureDiagnostic test
Serum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm
| Study group | Role | What they receive |
|---|---|---|
| Oocyte donors | Healthy oocyte donors undergoing ovarian stimulation with recombinant Follicular stimulating hormone Receives: Diagnostic Test: Serum progesterone measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progesterone variation among 4 different moments on the day of ovulation triggering
Measurement of serum Progesterone (ng/ml) in each oocyte donor at 4 different times on the day of ovulation triggering: The primary outcome will be the variation among the 4 progesterone measurements for each patient within the fixed12 hours time (8:00am; 12:00pm; 4:00pm and 8:00pm).
Measured: Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Nov 2017
- Primary completion25 Jan 2018
- Study completion25 Jan 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 Controlled Ovarian StimulationStudies 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
- 22 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Polyzos, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366025
- Sponsor's protocol ID
- SMD-VPD-2017-03
- Status last verified
- Apr 2018
- First submitted
- 28 Nov 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonzalez-Foruria I, Rodriguez I, Martinez F, Rodriguez-Purata J, Montoya P, Rodriguez D, Nicolau J, Coroleu B, Barri PN, Polyzos NP. Clinically significant intra-day variability of serum progesterone levels during the final day of oocyte maturation: a prospective study with repeated measurements. Hum Reprod. 2019 Aug 1;34(8):1551-1558. doi: 10.1093/humrep/dez091.
PubMed 31334546
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Variation on the Final Day of Oocyte Maturation. A Prospective Cohort Study With Repeated Measurements
- ClinicalTrials.gov ID
- NCT03366025
- Acronym / sponsor ID
- SMD-VPD-2017-03
- Conditions
- Controlled Ovarian Stimulation, Progesterone Variation on Trigger Day, Circadian Rhythm, Oocyte Donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 8 Dec 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.
The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oocyte donors | – | Diagnostic Test: Serum progesterone measureHealthy oocyte donors undergoing ovarian stimulation with recombinant Follicular stimulating hormone |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy oocyte donors according to spanish law for oocyte donation
Key inclusion criteria (3 listed)
- Healthy oocyte donors according to spanish law for oocyte donation
- Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone.
- Informed consent signed
Key exclusion criteria (1 listed)
- Detection of luteinizing hormone surge before triggering
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 |
|---|---|---|
| Serum progesterone measureSerum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm | Diagnostic test | Oocyte donors |
Primary outcome
Progesterone variation among 4 different moments on the day of ovulation triggering
Time frame: Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm
Measurement of serum Progesterone (ng/ml) in each oocyte donor at 4 different times on the day of ovulation triggering: The primary outcome will be the variation among the 4 progesterone measurements for each patient within the fixed12 hours time (8:00am; 12:00pm; 4:00pm and 8:00pm).
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 4 Apr 2018.
- Derived from this study: PubMed 31334546Gonzalez-Foruria I, Rodriguez I, Martinez F, Rodriguez-Purata J, Montoya P, Rodriguez D, Nicolau J, Coroleu B, Barri PN, Polyzos NP. Clinically significant intra-day variability of serum progesterone levels during the final day of oocyte maturation: a prospective study with repeated measurements. Hum Reprod. 2019 Aug 1;34(8):1551-1558. doi: 10.1093/humrep/dez091.
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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 Controlled Ovarian Stimulation and Progesterone Variation on Trigger Day, run by Fundacion Dexeus 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 3 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 4 Apr 2018. 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?
Progesterone variation among 4 different moments on the day of ovulation triggering (time frame: Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm). 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 NCT03366025, 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 4 Apr 2018.