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

NCT01111084 | Completed

• 1 other identifier: IMP24846
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovulation Induction

Keywords

Ovulation induction; Ovarian Hyperstimulation Syndrome; Pregnancy; Fertility

Outcome Measures

Primary Outcomes (1)

• Follicular development

  Number and size of follicles as determined through transvaginal ultrasound

  First 10 months from the inclusion of the subjects

Secondary Outcomes (2)

• Secondary efficacy assessments

  From baseline until the pregnancy or menstruation confirmation

• Safety assessments

  First 10 months from the inclusion of the subjects

Interventions

Follitropin alpha (r-FSH) DRUG

The dosage and administration of follitropin alpha was according to each centre's protocol and within technical specification recommendations.

Also known as: Gonal-f

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Hospital Ntra. Sra. De Valme

Seville, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Glycoprotein Hormones, alpha Subunit; follitropin alfa

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. Enrique Granados

  Merck Serono Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: March 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: July 16, 2014

Record last verified: 2010-04

Locations

ES (1)