Ectopic PregnancyNCT02793089
Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF
An observational study of Ectopic Pregnancy, run by IVI Vigo.
Trial summary
This study evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Analysis of Ectopic Pregnancy incidence
- How many people
- 578 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to May 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014.
Who may be able to join
- Normal Fallopian tubes in HSG and /or laparoscopy
- Normal Uterus: Abscence of myomas and Müllerian anomalies .
Who cannot join
- Previous Ectopic Pregnancy .
- Recurrent Abortion .
- Tubal Factor : pelvic inflammatory disease, Hydrosalpinx
- Previous abdominal surgery (except laparoscopy) .
- Prior Peritonitis
- Smoking (at least 1 cigarette/day) .
About this study
Official title: Retrospective Cohort Study of Increased Risk of Ectopic Pregnancy Associated With Marked Variation of Estradiol During the Early Luteal Phase and High Progesterone on hCG Day in IVF
This study evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF.
Read the detailed description
This is a retrospective cohort study of 578 patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014. Few studies have reported the relation between hormonal levels and ectopic pregnancy (EP) in IVF. Investigators describe EP incidence according to estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) or their variation between both days.
- Conditions
- Ectopic Pregnancy
- Being tested
- Analysis of Ectopic Pregnancy incidence
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of Ectopic Pregnancy incidenceOther
Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
| Study group | Role | What they receive |
|---|---|---|
| First quartile | No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7). Receives: Other: Analysis of Ectopic Pregnancy incidence | |
| Second quartile | No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7). Receives: Other: Analysis of Ectopic Pregnancy incidence | |
| Third quartile | No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) Receives: Other: Analysis of Ectopic Pregnancy incidence | |
| Fourth quartile | No drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) Receives: Other: Analysis of Ectopic Pregnancy incidence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ectopic pregnancy rate
Measured: Up to 108 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJan 2005
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ectopic 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
- Retrospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Responsible party
- Sponsor
- Investigators
- Elkin Muñoz, Principal investigator, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793089
- Sponsor's protocol ID
- 1409-VGO-059-EM
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.
PubMed 20539042Paltieli Y, Eibschitz I, Ziskind G, Ohel G, Silbermann M, Weichselbaum A. High progesterone levels and ciliary dysfunction--a possible cause of ectopic pregnancy. J Assist Reprod Genet. 2000 Feb;17(2):103-6. doi: 10.1023/a:1009465900824.
PubMed 10806589Cobo A, Bosch E, Alvarez C, de los Santos MJ, Pellicer A, Remohi J. Effect of a sharp serum oestradiol fall before HCG administration during ovarian stimulation in donors. Reprod Biomed Online. 2007 Aug;15(2):169-74. doi: 10.1016/s1472-6483(10)60705-5.
PubMed 17697492
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of Increased Risk of Ectopic Pregnancy Associated With Marked Variation of Estradiol During the Early Luteal Phase and High Progesterone on hCG Day in IVF
- ClinicalTrials.gov ID
- NCT02793089
- Acronym / sponsor ID
- 1409-VGO-059-EM
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Study start
- Jan 2005
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Jun 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 evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF.
Detailed description
This is a retrospective cohort study of 578 patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014. Few studies have reported the relation between hormonal levels and ectopic pregnancy (EP) in IVF. Investigators describe EP incidence according to estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) or their variation between both days.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First quartile | – | Other: Analysis of Ectopic Pregnancy incidenceNo drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7). |
| Second quartile | – | Other: Analysis of Ectopic Pregnancy incidenceNo drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7). |
| Third quartile | – | Other: Analysis of Ectopic Pregnancy incidenceNo drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) |
| Fourth quartile | – | Other: Analysis of Ectopic Pregnancy incidenceNo drugs are administered. It is an observational study. Collect retrospectively data.Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014.
Key inclusion criteria (2 listed)
- Normal Fallopian tubes in HSG and /or laparoscopy
- Normal Uterus: Abscence of myomas and Müllerian anomalies .
Key exclusion criteria (6 listed)
- Previous Ectopic Pregnancy .
- Recurrent Abortion .
- Tubal Factor : pelvic inflammatory disease, Hydrosalpinx
- Previous abdominal surgery (except laparoscopy) .
- Prior Peritonitis
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 Ectopic Pregnancy incidenceCollect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) | Other | First quartile, Fourth quartile, Second quartile, Third quartile |
Primary outcome
Ectopic pregnancy rate
Time frame: Up to 108 months
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 8 Jun 2016.
- Background: PubMed 20539042Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.
- Background: PubMed 10806589Paltieli Y, Eibschitz I, Ziskind G, Ohel G, Silbermann M, Weichselbaum A. High progesterone levels and ciliary dysfunction--a possible cause of ectopic pregnancy. J Assist Reprod Genet. 2000 Feb;17(2):103-6. doi: 10.1023/a:1009465900824.
- Results publication: PubMed 17697492Cobo A, Bosch E, Alvarez C, de los Santos MJ, Pellicer A, Remohi J. Effect of a sharp serum oestradiol fall before HCG administration during ovarian stimulation in donors. Reprod Biomed Online. 2007 Aug;15(2):169-74. doi: 10.1016/s1472-6483(10)60705-5.
- Individual participant dataSharing planned: No
Related trials for Ectopic Pregnancy
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Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.
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Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
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Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
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Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Ectopic Pregnancy
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.
Elkin Muñoz principal investigator
IVI Vigo
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by IVI Vigo.
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 2 inclusion and 6 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Ectopic pregnancy rate (time frame: Up to 108 months). 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 NCT02793089, which also lists 3 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 8 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.