PregnancyNCT02696694
Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles
An observational study of Pregnancy, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo… Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Progesterone 25-75 and Progesterone <25, >75
- How many people
- 242 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Oct 2016
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile patients undergoing their first or second egg donation cycle
Who may be able to join
- Age<50 yo
- BMI < 30Kg/m2
- Hormonal replacement cycle
- Endometrial thickness >6.5 mm during proliferative phase
- Transfer of one or two blastocyst grade A-B according to ASEBIR
Who cannot join
- Uterine pathology
- Cryptozoospermia
- Severe implantation failure (>6 GQ embryos transferred without success)
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 on the Success Rate in Egg Donation Cycles Under Hormonal Replacement
This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone levels and with chances of pregnancy.
- Conditions
- Pregnancy
- Being tested
- Progesterone 25-75, Progesterone <25, >75
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 25-75Other
Impact of serum progesterone concentrations [25-75] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy
Progesterone <25, >75Other
Impact of serum progesterone concentrations (<25, >75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| P25-P75 | serum progesterone between 25 and 75 percentile Receives: Other: Progesterone 25-75 | |
| <P25 ó >P75 | serum progesterone <25 or >75 percentile Receives: Other: Progesterone <25, >75 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mid-luteal serum progesterone level
Measured: one year
Secondary outcomes (1)
endometrial volume
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionOct 2016
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 PregnancyStudies 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
- 242 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
- NCT02696694
- Sponsor's protocol ID
- 1511-VLC-061-EL
- Other IDs
- IVI-EST-2015-01
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 29040638
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. 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 on the Success Rate in Egg Donation Cycles Under Hormonal Replacement
- ClinicalTrials.gov ID
- NCT02696694
- Acronym / sponsor ID
- 1511-VLC-061-EL
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Mar 2016 (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.
This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone levels and with chances of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P25-P75 | – | Other: Progesterone 25-75serum progesterone between 25 and 75 percentile |
| <P25 ó >P75 | – | Other: Progesterone <25, >75serum progesterone <25 or >75 percentile |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile patients undergoing their first or second egg donation cycle
Key inclusion criteria (5 listed)
- Age<50 yo
- BMI < 30Kg/m2
- Hormonal replacement cycle
- Endometrial thickness >6.5 mm during proliferative phase
- Transfer of one or two blastocyst grade A-B according to ASEBIR
Key exclusion criteria (3 listed)
- Uterine pathology
- Cryptozoospermia
- Severe implantation failure (>6 GQ embryos transferred without success)
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 25-75Impact of serum progesterone concentrations [25-75] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy | Other | P25-P75 |
| Progesterone <25, >75Impact of serum progesterone concentrations (<25, >75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy | Other | <P25 ó >P75 |
Primary outcome
mid-luteal serum progesterone level
Time frame: one year
1 secondary outcome
endometrial volume
Time frame: one year
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 29 Nov 2016.
- Derived from this study: 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.
- 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.
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 Pregnancy, 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 5 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 29 Nov 2016. 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?
mid-luteal serum progesterone level (time frame: one year). 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 NCT02696694, 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 29 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.