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

Completed

• Conditions: Ectopic Pregnancy
• Interventions: Other: Analysis of Ectopic Pregnancy incidence

• Registration Number: NCT02793089
• Lead Sponsor: IVI Vigo

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.

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 Timeline

• Study Start: 2005-01
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Study First Posted: 2016-06-08
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 578

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) .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Second quartile	Analysis of Ectopic Pregnancy incidence	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).
Third quartile	Analysis of Ectopic Pregnancy incidence	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)
First quartile	Analysis of Ectopic Pregnancy incidence	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).
Fourth quartile	Analysis of Ectopic Pregnancy incidence	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)

Primary Outcome Measures

Name	Time	Method
Ectopic pregnancy rate	Up to 108 months