An observational study in Ovarian Hyperstimulation Syndrome (OHSS), sponsored by Ferring Pharmaceuticals. Completed at 20 sites in France. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2017-05-31.
Sponsored by Ferring Pharmaceuticals · Observational
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.
64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.
This study's enrollment of 455 is above the median of 51 across 10 observational studies indexed under Ovarian Hyperstimulation Syndrome.
Browse Ovarian Hyperstimulation Syndrome studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Other: Highly purified menotropin (HP- hMG) treatment
No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
Incidence of moderate/severe OHSS
Time frame: 2-12 weeks
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
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Ovarian Hyperstimulation Syndrome→
Ferring Pharmaceuticals