Status:
COMPLETED
A Study to Evaluate the Baseline Follicle Stimulating Hormone, Ovarian Volume and Antral Follicle Count as Prognostic Factors of the Outcome of In-vitro Fertilisation/Intracytosolic Sperm Injection in Infertile Patients Receiving Gonal f for Controlled Ovarian Hyperstimulation
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Infertility
Eligibility:
FEMALE
20-43 years
Brief Summary
This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as progn...
Detailed Description
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gam...
Eligibility Criteria
Inclusion
- Pre-menopausal female subjects aged between 20-43 years
- Subjects requiring treatment with recombinant FSH for COH for IVF and/or ICSI
- Subjects who are able to communicate well with the investigator and can comply with the requirements of the entire study
- Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice
Exclusion
- Female subjects not pregnant or lactating
- Subjects with known allergic reaction against one of the ingredients
- Subjects with enlarged ovaries or cysts unrelated to polycystic ovarian disease.
- Subjects with gynaecological bleeding of unknown origin
- Subjects with ovarian, uterine, or mammary cancer
- Subjects with hyperprolactinaemia
- Subjects with tumors of the hypothalamus or the pituitary gland
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT01196143
Start Date
October 1 2008
End Date
January 1 2011
Last Update
February 4 2014
Active Locations (1)
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1
Centre of Assisted Reproduction "Embryoland"
Athens, Greece, 11 523