Clinical trial NCT01703728: 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.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Hyperstimulation Syndrome (OHSS)
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-10-10
Enrollment: 455
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Incidence of moderate/severe OHSS
timeFrame: 2-12 weeks
Secondary outcomes:
measure: Incidence of each form of OHSS: mild, moderate and severe
timeFrame: 2-13 weeks
measure: Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol
timeFrame: 2-13 weeks
measure: OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification
timeFrame: 2-13 weeks
measure: Patients' baseline characteristics
timeFrame: At baseline
measure: Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation
timeFrame: Up to 3 weeks
measure: Description and duration of hospitalisation, treatments prescribed
timeFrame: 2-13 weeks
measure: Frequency and reasons for stimulation arrest and no embryo transfer decision
timeFrame: 2-4 weeks
measure: Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos
timeFrame: 2-3 weeks
measure: Description of serious and not serious adverse events
timeFrame: 2-13 weeks
measure: Description of patient's compliance to the prescribed treatment
timeFrame: 2-4 weeks
measure: Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate
timeFrame: 4-13 weeks
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Cabinet Mirabeau Roy René (there may be other sites in this country)
city: Angers
country: France
facility: Hôtel Dieu
city: Beaumont
country: France
facility: Clinique La Chataigneraie
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Chambray les tours
country: France
facility: Clinique Léonard de Vinci
city: Créteil
country: France
facility: CHI
city: Dreux
country: France
facility: Hôpital Victor Jousselin
city: Ecully
country: France
facility: Institut Rhonalpin
city: Grenoble
country: France
facility: Cabinet Médical Maréchal Leclerc
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod
city: Lille
country: France
facility: Cabinet Médical Lille avenue de Dunkerque
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
city: Lyon
country: France
facility: Hôpital Privé Natecia
city: Marseille
country: France
facility: CHU de Marseille -Hôpital Conception
city: Metz
country: France
facility: Hôpital Maternité de Metz
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Cabinet Médical de Prony
city: Paris
country: France
facility: Hôpital St Vincent de Paul
city: Rennes
country: France
facility: CHU de Rennes
city: Rennes
country: France
facility: Clinique Mutualiste La Sagesse
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.