Ovarian Hyperstimulation Syndrome (OHSS)
Conditions
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.
Interventions
OTHERHighly purified menotropin (HP- hMG) treatment
No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate/severe OHSS | 2-12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of each form of OHSS: mild, moderate and severe | 2-13 weeks |
| OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification | 2-13 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 |
| Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol | 2-13 weeks |
Countries
France
Outcome results
None listed