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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Highly purified menotropin (HP- hMG) treatment | Other | No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate/severe OHSS | 2-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of each form of OHSS: mild, moderate and severe | 2-13 weeks | |
| Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol | 2-13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Mirabeau Roy René (there may be other sites in this country) | Aix-en-Provence | France | ||||
| Hôtel Dieu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28461237 | Result | 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. |
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No biological samples
| OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification | 2-13 weeks |
| Patients' baseline characteristics | At baseline |
| Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation | Up to 3 weeks |
| Description and duration of hospitalisation, treatments prescribed | 2-13 weeks |
| Frequency and reasons for stimulation arrest and no embryo transfer decision | 2-4 weeks |
| Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos | 2-3 weeks |
| Description of serious and not serious adverse events | 2-13 weeks |
| Description of patient's compliance to the prescribed treatment | 2-4 weeks |
| Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate | 4-13 weeks |
| Angers |
| France |
| Clinique La Chataigneraie | Beaumont | France |
| CHU Pellegrin | Bordeaux | France |
| Clinique Léonard de Vinci | Chambray-lès-Tours | France |
| CHI | Créteil | France |
| Hôpital Victor Jousselin | Dreux | France |
| Institut Rhonalpin | Écully | France |
| Cabinet Médical Maréchal Leclerc | Grenoble | France |
| Groupe Hospitalier du Havre - Hôpital Jacques Monod | Le Havre | France |
| Cabinet Médical Lille avenue de Dunkerque | Lille | France |
| Hôpital Jeanne de Flandre | Lille | France |
| Hôpital Privé Natecia | Lyon | France |
| CHU de Marseille -Hôpital Conception | Marseille | France |
| Hôpital Maternité de Metz | Metz | France |
| CHU de Nantes | Nantes | France |
| Cabinet Médical de Prony | Paris | France |
| Hôpital St Vincent de Paul | Paris | France |
| CHU de Rennes | Rennes | France |
| Clinique Mutualiste La Sagesse | Rennes | France |
| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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