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

NCT01196143 | Completed

• 1 other identifier: 700623-503
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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 prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving Gonal-f for controlled ovarian hyperstimulation (COH).

Conditions

Infertility

Keywords

Ovulation induction; Intrauterine insemination; Gonal-f; Controlled ovarian stimulation; Female infertility

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Up to 28 days after birth

Secondary Outcomes (9)

• Pregnancy rate (ongoing, clinical, biochemical)

  up to 40 weeks post embryo-transfer

• Fertilization rate

  24 hours post oocyte retrieval

• Implantation rate

  2 weeks post embryo-transfer

• Detailed record of adverse events

  Up to 1 year after subject enrollment

• Hormone (E2) levels on hCG day

  Up to 12 hours prior to hCG administration

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing COH for IVF/ICSI-treatment with Gonal-f in Greece.

You may qualify if:

• 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• Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Centre of Assisted Reproduction "Embryoland"

Athens, 11 523, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, urine

MeSH Terms

Conditions

Infertility; Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Michalis Arvanitis, MD, MSc

  Merck A.E. Hellas,Greece, an affiliate of MerckKGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: September 8, 2010
• Study Start: October 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

GR (1)