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.
NCT ID: NCT01703728
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
455 participants
OBSERVATIONAL
2012-11-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Highly purified menotropin (HP- hMG) treatment
No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
Interventions
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Highly purified menotropin (HP- hMG) treatment
No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
36 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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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-lès-Tours, , France
CHI
Créteil, , France
Hôpital Victor Jousselin
Dreux, , France
Institut Rhonalpin
Écully, , 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
Cabinet Médical de Prony
Paris, , France
Hôpital St Vincent de Paul
Paris, , France
CHU de Rennes
Rennes, , France
Clinique Mutualiste La Sagesse
Rennes, , France
Countries
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References
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Barriere P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.
Other Identifiers
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000012
Identifier Type: -
Identifier Source: org_study_id
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