Clinical trial NCT02701452: Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response
Official title: Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Hyperstimulation Syndrome
Hypercoagulability
Keywords: GnRH agonist triggering
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol

Exclusion Criteria:

* agonist protocol no health assurance estradiol level \< 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering

Primary outcomes:
measure: Number of patients with the presence of moderate to severe OHSS
timeFrame: The day of oocyte retrieval (Time 0).
Secondary outcomes:
measure: Dosage of Prothrombin time
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Dosage of APTT
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Dosage of fibrinogen
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Dosage of von Willebrand factor antigen Antithrombin,
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Dosage of DDimères
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Dosage of oestradiol
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Dosage of progesterone
timeFrame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
measure: Cumulative pregnancy rate after transfer of thawed embryos.
timeFrame: 2 months after the transfer of the last thawed embryo
measure: Number of patients with the presence of moderate to severe OHSS
timeFrame: 2 days after (T1) and 7 days after (T2) the oocyte retrieval
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Sophie Catteau-Jonard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: