Ovarian Hyperstimulation Syndrome (OHSS)SHOviewNCT01703728
Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.
An observational study of Ovarian Hyperstimulation Syndrome (OHSS), run by Ferring Pharmaceuticals at 20 sites in France.
Trial summary
Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome (OHSS)
- What is being tested?
- Highly purified menotropin (HP- hMG) treatment
- How many people
- 455 participants
- Where
- 20 sitesFrance
- Study dates
- Nov 2012to May 2014
- Phase
- Observational
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Study population: Women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI.
Who may be able to join
- Women who present infertility of more than one year and are candidates for a first or second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS.
- Absence of infertility treatment during the last 3 months before enrolment.
- Age: from 18 to 36 years old.
- BMI between 18 and 30 kg / m².
- Presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities.
- Male or female infertility.
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- Ovarian stimulation by HP-hMG with pituitary desensitization by a GnRH agonist or antagonist.
- Normal ovarian reserve according to physician habitual evaluation.
- Consent to participate of the no-interventional study and signature of the patients' information sheet.
Who cannot join
- Presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation.
- Known endometriosis grade III or IV.
- Contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician.
- Recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (PGD).
- Smoking over than 10 cigarettes / day.´
- Participation in an interventional study at the time of inclusion.
- Known poor ovarian response in a previous cycle of stimulation (number of oocyte collected ≤ 3, and / or more than 2 previous IVF/ICSI cycles and / or abnormal result in ovarian reserve test (AMH < 1 ng/ml with Immunotech equipment or AMH<0.7 ng/ml with DSL equipment).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Cabinet Mirabeau Roy René (there may be other sites in this country)
Aix-en-Provence
Hôtel Dieu
Angers
Clinique La Chataigneraie
Beaumont
CHU Pellegrin
Bordeaux
Clinique Léonard de Vinci
Chambray-lès-Tours
CHI
Créteil
Hôpital Victor Jousselin
Dreux
Institut Rhonalpin
Écully
Cabinet Médical Maréchal Leclerc
Grenoble
Groupe Hospitalier du Havre - Hôpital Jacques Monod
Le Havre
Cabinet Médical Lille avenue de Dunkerque
Lille
Hôpital Jeanne de Flandre
Lille
Hôpital Privé Natecia
Lyon
CHU de Marseille -Hôpital Conception
Marseille
Hôpital Maternité de Metz
Metz
CHU de Nantes
Nantes
Cabinet Médical de Prony
Paris
Hôpital St Vincent de Paul
Paris
CHU de Rennes
Rennes
Clinique Mutualiste La Sagesse
Rennes
About this study
Official title: SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.
Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.
- Conditions
- Ovarian Hyperstimulation Syndrome (OHSS)
- Being tested
- Highly purified menotropin (HP- hMG) treatment
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly purified menotropin (HP- hMG) treatmentOther
No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
| Study group | Role | What they receive |
|---|---|---|
| Highly purified menotropin (HP-hMG) treatment | Cohort of women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI. Receives: Other: Highly purified menotropin (HP- hMG) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate/severe OHSS
Measured: 2-12 weeks
Secondary outcomes (11)
Incidence of each form of OHSS: mild, moderate and severe
Measured: 2-13 weeks
Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol
Measured: 2-13 weeks
OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification
Measured: 2-13 weeks
Patients' baseline characteristics
Measured: At baseline
Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation
Measured: Up to 3 weeks
Description and duration of hospitalisation, treatments prescribed
Measured: 2-13 weeks
Frequency and reasons for stimulation arrest and no embryo transfer decision
Measured: 2-4 weeks
Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos
Measured: 2-3 weeks
Description of serious and not serious adverse events
Measured: 2-13 weeks
Description of patient's compliance to the prescribed treatment
Measured: 2-4 weeks
Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate
Measured: 4-13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Hyperstimulation Syndrome (OHSS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703728
- Sponsor's protocol ID
- 000012
- Acronym
- SHOview
- Status last verified
- May 2017
- First submitted
- 3 Oct 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Barriere P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.
PubMed 28461237
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.
- ClinicalTrials.gov ID
- NCT01703728
- Acronym / sponsor ID
- SHOview / 000012
- Conditions
- Ovarian Hyperstimulation Syndrome (OHSS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Oct 2012 (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.
Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Highly purified menotropin (HP-hMG) treatment | – | Other: Highly purified menotropin (HP- hMG) treatmentCohort of women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI.
Key inclusion criteria (9 listed)
- Women who present infertility of more than one year and are candidates for a first or second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS.
- Absence of infertility treatment during the last 3 months before enrolment.
- Age: from 18 to 36 years old.
- BMI between 18 and 30 kg / m².
- Presence of both ovaries accessible to puncture and absence of ovarian or uterine abnormalities.
Key exclusion criteria (7 listed)
- Presence of a chronic disease, cancer or endocrine disease that could potentially influence the results of the stimulation or that represents a contraindication for ovarian stimulation.
- Known endometriosis grade III or IV.
- Contraindication to the use of gonadotropins or current pregnancy diagnosed by the clinician.
- Recurrent miscarriages, known genetic disease of one of the partners or indication of a preimplantation genetic diagnosis (PGD).
- Smoking over than 10 cigarettes / day.´
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 |
|---|---|---|
| Highly purified menotropin (HP- hMG) treatmentNo intervention: patients treated by highly purified menotropin for COS according to physicians' current practice | Other | Highly purified menotropin (HP-hMG) treatment |
Primary outcome
Incidence of moderate/severe OHSS
Time frame: 2-12 weeks
11 secondary outcomes
Incidence of each form of OHSS: mild, moderate and severe
Time frame: 2-13 weeks
Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol
Time frame: 2-13 weeks
OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification
Time frame: 2-13 weeks
Patients' baseline characteristics
Time frame: At baseline
Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation
Time frame: Up to 3 weeks
Description and duration of hospitalisation, treatments prescribed
Time frame: 2-13 weeks
Frequency and reasons for stimulation arrest and no embryo transfer decision
Time frame: 2-4 weeks
Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos
Time frame: 2-3 weeks
Description of serious and not serious adverse events
Time frame: 2-13 weeks
Description of patient's compliance to the prescribed treatment
Time frame: 2-4 weeks
Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate
Time frame: 4-13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Results publication: PubMed 28461237Barriere P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Hyperstimulation Syndrome (OHSS), run by Ferring Pharmaceuticals at 20 sites in France.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of moderate/severe OHSS (time frame: 2-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01703728, which also lists 1 linked publication.
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 31 May 2017.