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Completed

NCT Number: NCT02793089

Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels 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.

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) .

Treatment and study plan

Analysis of Ectopic Pregnancy incidence

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)

Primary outcomes

  1. Ectopic pregnancy rate

    Time frame: Up to 108 months

Sponsors and collaborators

Lead sponsor

IVI Vigo

Other

Collaborators

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2016
Registry last updated
Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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