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

Ectopic Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793089
• Other study ID #: 1409-VGO-059-EM
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: June 2, 2016
• Start date: January 2005
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
IVI Vigo	Instituto Valenciano de Infertilidad, IVI VALENCIA

References & Publications (3)

Bosch E, Labarta E, Crespo J, Simón C, Remohí 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. — View Citation

Cobo A, Bosch E, Alvarez C, de los Santos MJ, Pellicer A, Remohí 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ectopic pregnancy rate		Up to 108 months	No