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French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menotropin Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative live birth rate (cLBR) | Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS. | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Initial dose of Menotropin treatment per IVF cycle (IU) | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 | |
| Total dose of Menotropin treatment per IVF cycle (IU) | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 |
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Inclusion Criteria:
- Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016
Exclusion Criteria:
Adult females who underwent COS treatment with Menotropin during 2009 to 2016.
Adult women, fitting the inclusion/exclusion criteria, who were prescribed Menotropin during 2009 to 2016 for COS in a treatment of infertility will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferring investigational site | Bondy | 93140 | France | |||
| Ferring investigational site |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Total days of Menotropin treatment (per IVF cycle) | Duration of treatment (in days) with Menotropin of patients will be reported. | Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016 |
| Dose adjustment of Menotropin in IU | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 |
| Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist) | Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist. | At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016 |
| Total days of LH surge suppression protocol | Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist. | From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016 |
| Clamart |
| 92140 |
| France |
| Ferring investigational site | Créteil | 94010 | France |
| Ferring investigational site | Le Chesnay | 78150 | France |
| Ferring investigational site | Lens | 62190 | France |
| Ferring investigational site | Lyon | 69002 | France |
| Ferring investigational site | Marseille | 13008 | France |
| Ferring investigational site | Nice | 06100 | France |
| Ferring investigational site | Rennes | 35000 | France |
| Ferring investigational site | Rennes | 35033 | France |
| D000091662 | Genital Diseases |
| D007246 | Infertility |