Trials / Terminated
TerminatedNCT02701452
Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response
Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- Female
- Age
- 18 Years – 43 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Seventy-five patients will be required for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | COAGO | blood samples for haemostasis and hormonal data |
Timeline
- Start date
- 2016-02-26
- Primary completion
- 2019-01-01
- Completion
- 2019-01-01
- First posted
- 2016-03-08
- Last updated
- 2019-10-04
Source: ClinicalTrials.gov record NCT02701452. Inclusion in this directory is not an endorsement.