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. (SHOview)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01703728
First received: October 3, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Ovarian Hyperstimulation Syndrome (OHSS)
Other: Highly purified menotropin (HP- hMG) treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of moderate/severe OHSS [ Time Frame: 2-12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of each form of OHSS: mild, moderate and severe [ Time Frame: 2-13 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol [ Time Frame: 2-13 weeks ] [ Designated as safety issue: Yes ]
  • OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification [ Time Frame: 2-13 weeks ] [ Designated as safety issue: Yes ]
  • Patients' baseline characteristics [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]
  • Description and duration of hospitalisation, treatments prescribed [ Time Frame: 2-13 weeks ] [ Designated as safety issue: Yes ]
  • Frequency and reasons for stimulation arrest and no embryo transfer decision [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Description of serious and not serious adverse events [ Time Frame: 2-13 weeks ] [ Designated as safety issue: Yes ]
  • Description of patient's compliance to the prescribed treatment [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
  • Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate [ Time Frame: 4-13 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

No biological samples


Enrollment: 455
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Highly purified menotropin (HP- hMG) treatment
No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703728

Locations
France
Cabinet Mirabeau Roy René (there may be other sites in this country)
Aix En Provence, France
Hôtel Dieu
Angers, France
Clinique La Chataigneraie
Beaumont, France
CHU Pellegrin
Bordeaux, France
Clinique Léonard de Vinci
Chambray les tours, France
CHI
Créteil, France
Hôpital Victor Jousselin
Dreux, France
Institut Rhonalpin
Ecully, 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
Hôpital St Vincent de Paul
Paris, France
Cabinet Médical de Prony
Paris, France
CHU de Rennes
Rennes, France
Clinique Mutualiste La Sagesse
Rennes, France
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01703728     History of Changes
Other Study ID Numbers: 000012
Study First Received: October 3, 2012
Last Updated: July 16, 2014
Health Authority: France: CPP (Committee for Personal Protection)
France: CCTIRS (Advisory Committee for Data Processing in Health Research) and CNIL (Fench authority for data protection).

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014