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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Follicle Stimulating Hormone

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