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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01111084
First received: April 23, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Ovulation Induction
Drug: Follitropin alpha (r-FSH)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multi-centre Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Follicular development [ Time Frame: First 10 months from the inclusion of the subjects ] [ Designated as safety issue: No ]
    Number and size of follicles as determined through transvaginal ultrasound


Secondary Outcome Measures:
  • Secondary efficacy assessments [ Time Frame: From baseline until the pregnancy or menstruation confirmation ] [ Designated as safety issue: No ]
    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

  • Safety assessments [ Time Frame: First 10 months from the inclusion of the subjects ] [ Designated as safety issue: Yes ]
    Incidence of adverse occurrences, in particular OHSS; proportion of multiple pregnancies and local reaction at the injection point.


Biospecimen Retention:   Samples With DNA

Serum


Enrollment: 410
Study Start Date: March 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Follitropin alpha (r-FSH)
    The dosage and administration of follitropin alpha was according to each centre's protocol and within technical specification recommendations.
    Other Name: Gonal-f
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
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111084

Locations
Spain
Hospital Ntra. Sra. De Valme
Sevilla, Spain
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Dr. Enrique Granados Merck Serono Spain
  More Information

No publications provided

Responsible Party: Dr. Sebastián Burgués/Medical Manager, Merck Serono Spain, an affilaite of MerckKGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01111084     History of Changes
Other Study ID Numbers: IMP24846
Study First Received: April 23, 2010
Last Updated: April 23, 2010
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Merck KGaA:
Ovulation induction
Ovarian Hyperstimulation Syndrome
Pregnancy
Fertility

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014