Ovarian Hyperstimulation SyndromeCOAGONCT02701452
Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response
A study testing COAGO in people with Ovarian Hyperstimulation Syndrome and Hypercoagulability, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome, Hypercoagulability
- What is being tested?
- COAGO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2016to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol
Who cannot join
- agonist protocol no health assurance estradiol level < 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering
About this study
Official title: Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist
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.
Read the detailed description
Seventy-five patients will be required for this study.
- Being tested
- COAGO
- Keywords
- GnRH agonist triggering
- Medical subject headings
- Ovarian Hyperstimulation Syndrome, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COAGOOther
blood samples for haemostasis and hormonal data
| Study group | Role | What they receive |
|---|---|---|
| COAGO | Experimental | 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) were triggered by GnRH agonist. Receives: Other: COAGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with the presence of moderate to severe OHSS
The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite):
- Clinical: weight, waist circumference, dyspnea, EVA, diuresis
- Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein
- Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).
Measured: The day of oocyte retrieval (Time 0).
Secondary outcomes (9)
Dosage of Prothrombin time
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of APTT
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of fibrinogen
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of von Willebrand factor antigen Antithrombin,
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of DDimères
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of oestradiol
To evaluate its decrease.
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of progesterone
To evaluate the quality of lutea and date of post punctures rules
Measured: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Cumulative pregnancy rate after transfer of thawed embryos.
Measured: 2 months after the transfer of the last thawed embryo
Number of patients with the presence of moderate to severe OHSS
The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite):
- Clinical: weight, waist circumference, dyspnea, EVA, diuresis
- Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein
- Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).
Measured: 2 days after (T1) and 7 days after (T2) the oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start26 Feb 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Catteau-Jonard, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701452
- Sponsor's protocol ID
- 2014_08
- Other IDs
- 2015-A01291-48
- Acronym
- COAGO
- Status last verified
- Oct 2019
- First submitted
- 25 Feb 2016
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist
- ClinicalTrials.gov ID
- NCT02701452
- Acronym / sponsor ID
- COAGO / 2014_08
- Keywords
- GnRH agonist triggering
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COAGO | Experimental | Other: COAGOAll 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) were triggered by GnRH agonist. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol
Key exclusion criteria (1 listed)
- agonist protocol no health assurance estradiol level < 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COAGOblood samples for haemostasis and hormonal data | Other | COAGO |
Primary outcome
Number of patients with the presence of moderate to severe OHSS
Time frame: The day of oocyte retrieval (Time 0).
The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): * Clinical: weight, waist circumference, dyspnea, EVA, diuresis * Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein * Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).
9 secondary outcomes
Dosage of Prothrombin time
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of APTT
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of fibrinogen
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of von Willebrand factor antigen Antithrombin,
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of DDimères
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of oestradiol
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Dosage of progesterone
Time frame: The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Cumulative pregnancy rate after transfer of thawed embryos.
Time frame: 2 months after the transfer of the last thawed embryo
Number of patients with the presence of moderate to severe OHSS
Time frame: 2 days after (T1) and 7 days after (T2) the oocyte retrieval
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Catteau-Jonard, MD, PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A study testing COAGO in people with Ovarian Hyperstimulation Syndrome and Hypercoagulability, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with the presence of moderate to severe OHSS (time frame: The day of oocyte retrieval (Time 0).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.