Infertility Clinical Trial
Official title:
Pergoveris Non Interventional Study
This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice. The results will be used for the "Periodic Safety Update Report", which is to be regularly sent to the European Medicines Agency (EMEA) and the responsible German Higher Federal Authority (BfArM).
Female subjects with distinctive follicle stimulating hormone (FSH) and LH deficiency
require both FSH and LH. Until now these subjects were treated either with a combination of
two recombinant preparations (r-hFSH and r-hLH) or else with a menotropin preparation,
composed of urinary human FSH (u-hFSH) and human chorionic gonadotropin (hCG) as
LH-replacement.
In Pergoveris™ for the first time both hormones FSH and LH are available as recombinant
produced hormones in a combination preparation.
Pergoveris has both hormones i.e. FSH and LH available as recombinant produced hormones in a
combination preparation in the ratio 2:1. This study is planned to record data for the
stimulation not only in case of the ovarian stimulation with intercourse for the optimum
(VZO) but also the intrauterine insemination (IUI) and the ovarian stimulation for the
assisted reproduction [in-vitro fertilisation (IVF) and intracytoplasmatic sperm injection
(ICSI)] in subjects with severe FSH and LH deficiency and learn more about this subject
group and the applied stimulation plan.
Apart from the demographic data, anamnestic details e.g. reason for the infertility,
duration of the unfulfilled wish for children, past medical treatment for conception and
accompanying illnesses will be documented. The duration of the stimulation with Pergoveris
as well as the dose per day will be recorded from the cycle documentations. Follicle sizes
and hormones will be documented in accordance with the respectively carried out cycle
monitoring. The result of the treatment is related to the number of cycles with ovulation
stimulation using hCG, the number of the cycles with puncture, the number of the cycles with
embryo transfer, the number and quality of the ova and embryos, on occurred pregnancies and
documented abortions. Multiple pregnancies and births will also be recorded.
OBJECTIVES
- To find the reason for the diagnosis of the severe LH deficiency such as e.g. low
endogenous LH, amenorrhea, low endometrial thickness or low estradiol level.
;
Observational Model: Cohort, Time Perspective: Prospective
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