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)

May 29, 2017 updated by: Ferring Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

455

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix En Provence, France
        • Cabinet Mirabeau Roy René (there may be other sites in this country)
      • Angers, France
        • Hotel Dieu
      • Beaumont, France
        • Clinique la Chataigneraie
      • Bordeaux, France
        • CHU Pellegrin
      • Chambray les tours, France
        • Clinique Léonard de Vinci
      • Créteil, France
        • CHI
      • Dreux, France
        • Hopital Victor Jousselin
      • Ecully, France
        • Institut Rhonalpin
      • Grenoble, France
        • Cabinet Médical Maréchal Leclerc
      • Le Havre, France
        • Groupe Hospitalier du Havre - Hôpital Jacques Monod
      • Lille, France
        • Hôpital Jeanne de Flandre
      • Lille, France
        • Cabinet Médical Lille avenue de Dunkerque
      • Lyon, France
        • Hôpital Privé Natecia
      • Marseille, France
        • CHU de Marseille -Hôpital Conception
      • Metz, France
        • Hôpital Maternité de Metz
      • Nantes, France
        • CHU de Nantes
      • Paris, France
        • Hôpital St Vincent de Paul
      • Paris, France
        • Cabinet Médical de Prony
      • Rennes, France
        • CHU de Rennes
      • Rennes, France
        • Clinique Mutualiste la Sagesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of moderate/severe OHSS
Time Frame: 2-12 weeks
2-12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of each form of OHSS: mild, moderate and severe
Time Frame: 2-13 weeks
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
2-13 weeks
OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification
Time Frame: 2-13 weeks
2-13 weeks
Patients' baseline characteristics
Time Frame: At baseline
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
Up to 3 weeks
Description and duration of hospitalisation, treatments prescribed
Time Frame: 2-13 weeks
2-13 weeks
Frequency and reasons for stimulation arrest and no embryo transfer decision
Time Frame: 2-4 weeks
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
2-3 weeks
Description of serious and not serious adverse events
Time Frame: 2-13 weeks
2-13 weeks
Description of patient's compliance to the prescribed treatment
Time Frame: 2-4 weeks
2-4 weeks
Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate
Time Frame: 4-13 weeks
4-13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 29, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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