Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

NCT ID: NCT02793089

Last Updated: 2016-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

578 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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

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Ectopic Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Analysis of Ectopic Pregnancy incidence

Intervention Type OTHER

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

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).

Analysis of Ectopic Pregnancy incidence

Intervention Type OTHER

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

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)

Analysis of Ectopic Pregnancy incidence

Intervention Type OTHER

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

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)

Analysis of Ectopic Pregnancy incidence

Intervention Type OTHER

Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)

Interventions

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Analysis of Ectopic Pregnancy incidence

Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role collaborator

IVI Vigo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elkin Muñoz

Role: PRINCIPAL_INVESTIGATOR

IVI Vigo

References

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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.

Reference Type BACKGROUND
PMID: 20539042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10806589 (View on PubMed)

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.

Reference Type RESULT
PMID: 17697492 (View on PubMed)

Other Identifiers

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1409-VGO-059-EM

Identifier Type: -

Identifier Source: org_study_id

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