A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α (P450)

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

Prospective Multi-centre Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α

This is a prospective and multicentric observational study to determine the real mono-bifollicular development rate that is obtained under normal care conditions following ovulation induction (OI) treatment with follitropin-alpha filled by mass prescribed in accordance with standard practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In women with infertility due to anovulation, the main purpose of ovulation induction (OI) consists in inducing the mono or bifollicular and the subsequent ovulation in order to achieve pregnancy. The availability of recombinant gonadotropins obtained using genetically engineered techniques has meant a decisive and clear pharmacological advancement. Use of recombinant human follicle stimulating hormone (r-hFSH) offers a greater effectiveness (greater number of follicles/ ovocytes and a higher pregnancy rate) and efficiency (fewer number of blisters, fewer stimulation days; fewer number of cancellations and complications) in programmed coitus and artificial insemination like in-vitro fertilisation (IVF)/intra cytoplasmic sperm injection (ICSI) techniques. Further advances in obtaining better products for ovarian stimulation has led to production of a recombinant FSH (follitropin alpha) filled by mass preparation. This hormone becomes the most consistent and precise gonadotropin due to improvements in its quantification process.

Today, despite having accurate and modern tools for ovulation induction, in daily practice, doctors continue to "fight" against two old problems of assisted reproduction: multiple pregnancies and ovarian hyperstimulation syndrome (OHSS). Application of assisted reproduction techniques (ARTs) and the use of medication that induce ovulation, risk producing gestations and multiple births with a higher frequency than those observed in spontaneous gestations. One of the facts that result in the appearance of such problems is the high incidence of polycystic ovarian syndrome among the population of women who are infertile due to anovulation. These subjects are especially sensitive to ovarian stimulation, which leads to multiple follicular development, a higher risk of hyperstimulation and higher rates of multiple pregnancies.

Therefore, it seems clear that the search for developing mono or bifollicular cycles is important in ovarian induction cycles, for the purpose of preventing the above mentioned multiple pregnancy problems and the risk of OHSS. The intent of this study was to figure out the real mono-bifollicular development rate that is obtained under normal care conditions following OI treatment with follitropin alpha filled by mass prescribed in accordance with standard practice. Therefore, a measure of the efficiency of the product for achieving the development of one or two follicles. Data was collected from 56 centres of the Autonomous Communities that accepted this observational study, until achieving a total of 410 ovulation induction cycles.

OBJECTIVES

Primary objective:

  • To find the real proportion of cycles with mono-bifollicular development during the provision of care involving OI with follitropin alpha filled by mass

Secondary objectives:

  • To evaluate if the use of follitropin alpha filled by mass has other clinical benefits such as a reduction in the number of cancelled cycles, of the dosage and time required and adverse effects

Study Type

Observational

Enrollment (Actual)

410

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

  • Spain
      • Sevilla, Spain
        • Hospital Ntra. Sra. De Valme

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female subjects who were infertile due to anovulation undergoing OI treatment with follitropin alpha prescribed in accordance with the standard practice and in accordance with the technical specifications.

Description

Inclusion Criteria:

  • Premenopausal women with infertility caused by anovulation, who wished to conceive and were included in an ovulation induction (OI) treatment protocol for intrauterine insemination or for programmed coitus

Exclusion Criteria:

  • Subjects with hypersensitivity to follitropin alpha, to FSH or to any of the excipients
  • Subjects with hypothalamic or pituitary tumours
  • Subjects with increase in the size of the ovaries or cysts that were not due to polycystic ovary disease
  • Subjects with gynaecologic haemorrhages of unknown aetiology
  • Subjects with ovarian, uterine or mammary carcinoma
  • Subjects with primary ovarian failure
  • Subjects with malformations of sex organs that were not compatible with pregnancy
  • Subjects with uterine fibroid tumours that were not compatible with pregnancy

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
Follicular development
Time Frame: First 10 months from the inclusion of the subjects
Number and size of follicles as determined through transvaginal ultrasound
First 10 months from the inclusion of the subjects

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy assessments
Time Frame: From baseline until the pregnancy or menstruation confirmation
Duration of ovulation induction; total accumulated dosage of follitropin alpha; cycles cancelled due to insufficient response or due to risk of ovarian hyperstimulation; proportion of pregnancies
From baseline until the pregnancy or menstruation confirmation
Safety assessments
Time Frame: First 10 months from the inclusion of the subjects
Incidence of adverse occurrences, in particular OHSS; proportion of multiple pregnancies and local reaction at the injection point.
First 10 months from the inclusion of the subjects

Collaborators and Investigators

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

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Dr. Enrique Granados, Merck Serono Spain

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

March 1, 2004

Primary Completion (ACTUAL)

June 1, 2005

Study Completion (ACTUAL)

June 1, 2005

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (ESTIMATE)

April 27, 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, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP24846

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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