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Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response

NCT02701452 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-10-04

No results posted yet for this study

Summary

In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high risk populations 9 days after oocyte triggering with hCG. Many studies report no or a markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However, criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It is well known that OHSS is associated with hypercoagulability. However, no study after triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high circulating estradiol levels.

Study design, size, duration: In a French academic reproductive medicine centre, a systematic prospective observational follow-up of all patients triggered by GnRH agonist for excessive follicular response will be conducted. Participants/materials, setting, methods: All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by GnRH agonist. No luteal phase support and a "freeze-all" strategy will be performed. On the day of oocyte retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability will be systematically assessed. Haemostasis data will be compared to the initial status of each patient.

Conditions

  • Ovarian Hyperstimulation Syndrome
  • Hypercoagulability

Interventions

OTHER

COAGO

blood samples for haemostasis and hormonal data

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Sophie Catteau-Jonard, MD, PhD · University Hospital, Lille

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-26
Primary Completion
2019-01-01
Completion
2019-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701452 on ClinicalTrials.gov