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.

Ferring Pharmaceuticals20 sites in 1 country455 target enrollmentNovember 2012

ConditionsOvarian Hyperstimulation Syndrome (OHSS)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ovarian Hyperstimulation Syndrome (OHSS)
Sponsor: Ferring Pharmaceuticals
Enrollment: 455
Locations: 20
Primary Endpoint: Incidence of moderate/severe OHSS
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

May 2014

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Incidence of moderate/severe OHSS

Time Frame: 2-12 weeks

Secondary Outcomes

Incidence of each form of OHSS: mild, moderate and severe(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)
Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol(2-13 weeks)
Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation(Up to 3 weeks)
OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification(2-13 weeks)
Patients' baseline characteristics(At baseline)
Description and duration of hospitalisation, treatments prescribed(2-13 weeks)
Frequency and reasons for stimulation arrest and no embryo transfer decision(2-4 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)