Infertility, Female
Conditions
Keywords
Menotropin, HP-hMG
Brief summary
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.
Interventions
OTHERNo intervention
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.
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
\- Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016
Exclusion criteria
* Ovulation inductions * Intra-uterine inseminations * Fertility preservations * Oocyte donations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative live birth rate (cLBR) | At delivery | Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Total days of Menotropin treatment (per IVF cycle) | Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016 | Duration of treatment (in days) with Menotropin of patients will be reported. |
| 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 | — |
| Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (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 | Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist. |
| Total days of LH surge suppression protocol | From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016 | Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist. |
| Dose adjustment of Menotropin in IU | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 | — |
Countries
France
Outcome results
None listed