Clinical trial NCT01112618: A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice
Official title: Pergoveris Non Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Reproductive technologies, Assisted
r-hFSH
r-hLH
Pergoveris
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 3247
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing stimulation with Pergoveris for the ovarian stimulation with intercourse for the optimum (VZO) or with IUI or in preparation for a technology of the assisted conception such as IVF or ICSI.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female subjects undergoing stimulation with Pergoveris for the ovarian stimulation with VZO or with IUI or in preparation for a technology of the assisted conception such as IVF or ICSI

Exclusion Criteria:

* Subjects receiving combination cycles with clomifen, follitropin beta, urinary FSH, urinary human menopausal gonadotropin (hMG)

Primary outcomes:
measure: Reason for diagnosis of severe LH deficiency
timeFrame: 6 months
Secondary outcomes:
measure: Dose on the first day and the last day of treatment; duration of the stimulation; and the total dose of Pergoveris.
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Fertility Center Berlin, Spandauer Damm 130
Study officials:
affiliation: Merck Serono GmbH, Germany
name: Sigbert Jahn, PhD
role: STUDY_DIRECTOR
References:
citation: Buhler K, Naether OG, Bilger W. A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology. Reprod Biol Endocrinol. 2014 Jan 14;12:6. doi: 10.1186/1477-7827-12-6.