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.

Completed

• Conditions: Ovarian Hyperstimulation Syndrome (OHSS)
• Interventions: Other: Highly purified menotropin (HP- hMG) treatment

• Registration Number: NCT01703728
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-10
• Study Start: 2012-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 455

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Highly purified menotropin (HP-hMG) 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.

Primary Outcome Measures

Name	Time	Method
Incidence of moderate/severe OHSS	2-12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Cabinet Mirabeau Roy René (there may be other sites in this country); 🇫🇷 Aix En Provence, France

Hôpital Privé Natecia; 🇫🇷 Lyon, France

Hôtel Dieu; 🇫🇷 Angers, France

Clinique La Chataigneraie; 🇫🇷 Beaumont, France

Hôpital Victor Jousselin; 🇫🇷 Dreux, France

Institut Rhonalpin; 🇫🇷 Ecully, France

Hôpital Jeanne de Flandre; 🇫🇷 Lille, France

CHU Pellegrin; 🇫🇷 Bordeaux, France

Cabinet Médical Maréchal Leclerc; 🇫🇷 Grenoble, France

Clinique Léonard de Vinci; 🇫🇷 Chambray les tours, France

Hôpital Maternité de Metz; 🇫🇷 Metz, France

CHU de Nantes; 🇫🇷 Nantes, France

Groupe Hospitalier du Havre - Hôpital Jacques Monod; 🇫🇷 Le Havre, France

Cabinet Médical Lille avenue de Dunkerque; 🇫🇷 Lille, France

CHU de Marseille -Hôpital Conception; 🇫🇷 Marseille, France

Cabinet Médical de Prony; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

Clinique Mutualiste La Sagesse; 🇫🇷 Rennes, France

Hôpital St Vincent de Paul; 🇫🇷 Paris, France

CHI; 🇫🇷 Créteil, France