A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice

July 15, 2014 updated by: Merck KGaA, Darmstadt, Germany

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

3247

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Fertility Center Berlin, Spandauer Damm 130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reason for diagnosis of severe LH deficiency
Time Frame: 6 months
The reasons for the diagnosis of severe LH deficiency could be low endogenous LH, amenorrhea, low endometrial thickness, low estradiol levels.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose on the first day and the last day of treatment; duration of the stimulation; and the total dose of Pergoveris.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Sigbert Jahn, PhD, Merck Serono GmbH, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200061-500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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