NCT02793089

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
Last Updated

June 8, 2016

Status Verified

May 1, 2016

Enrollment Period

11.3 years

First QC Date

May 18, 2016

Last Update Submit

June 2, 2016

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Ectopic pregnancy rate

    Up to 108 months

Study Arms (4)

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).

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).

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)

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)

Other: Analysis of Ectopic Pregnancy incidence

Interventions

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)

First quartileFourth quartileSecond quartileThird quartile

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014.

You may qualify if:

  • Normal Fallopian tubes in HSG and /or laparoscopy
  • Normal Uterus: Abscence of myomas and Müllerian anomalies .

You may not qualify if:

  • Previous Ectopic Pregnancy .
  • Recurrent Abortion .
  • Tubal Factor : pelvic inflammatory disease, Hydrosalpinx
  • Previous abdominal surgery (except laparoscopy) .
  • Prior Peritonitis
  • Smoking (at least 1 cigarette/day) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20539042BACKGROUND

  • Paltieli 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.

    PMID: 10806589BACKGROUND

  • Cobo 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.

    PMID: 17697492RESULT

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Elkin Muñoz

    IVI Vigo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

June 8, 2016

Study Start

January 1, 2005

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share