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)
29. maj 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
455
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aix En Provence, Frankrig
- Cabinet Mirabeau Roy René (there may be other sites in this country)
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Angers, Frankrig
- Hôtel Dieu
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Beaumont, Frankrig
- Clinique la Chataigneraie
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Bordeaux, Frankrig
- CHU Pellegrin
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Chambray les tours, Frankrig
- Clinique Leonard de Vinci
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Créteil, Frankrig
- CHI
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Dreux, Frankrig
- Hôpital Victor Jousselin
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Ecully, Frankrig
- Institut Rhonalpin
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Grenoble, Frankrig
- Cabinet Médical Maréchal Leclerc
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Le Havre, Frankrig
- Groupe Hospitalier du Havre - Hôpital Jacques Monod
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Lille, Frankrig
- Hôpital Jeanne de Flandre
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Lille, Frankrig
- Cabinet Médical Lille avenue de Dunkerque
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Lyon, Frankrig
- Hôpital Privé Natecia
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Marseille, Frankrig
- CHU de Marseille -Hôpital Conception
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Metz, Frankrig
- Hôpital Maternité de Metz
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Nantes, Frankrig
- CHU de Nantes
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Paris, Frankrig
- Hôpital St Vincent de Paul
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Paris, Frankrig
- Cabinet Médical de Prony
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Rennes, Frankrig
- CHU de Rennes
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Rennes, Frankrig
- Clinique mutualiste La Sagesse
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 36 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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.
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No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of moderate/severe OHSS
Tidsramme: 2-12 weeks
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2-12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Incidence of each form of OHSS: mild, moderate and severe
Tidsramme: 2-13 weeks
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2-13 weeks
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Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol
Tidsramme: 2-13 weeks
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2-13 weeks
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OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification
Tidsramme: 2-13 weeks
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2-13 weeks
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Patients' baseline characteristics
Tidsramme: At baseline
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At baseline
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Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation
Tidsramme: Up to 3 weeks
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Up to 3 weeks
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Description and duration of hospitalisation, treatments prescribed
Tidsramme: 2-13 weeks
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2-13 weeks
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Frequency and reasons for stimulation arrest and no embryo transfer decision
Tidsramme: 2-4 weeks
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2-4 weeks
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Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos
Tidsramme: 2-3 weeks
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2-3 weeks
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Description of serious and not serious adverse events
Tidsramme: 2-13 weeks
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2-13 weeks
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Description of patient's compliance to the prescribed treatment
Tidsramme: 2-4 weeks
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2-4 weeks
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Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate
Tidsramme: 4-13 weeks
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4-13 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2012
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
3. oktober 2012
Først indsendt, der opfyldte QC-kriterier
9. oktober 2012
Først opslået (Skøn)
10. oktober 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 000012
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