Efficacy of Ovarian Stimulation Based on FSHR Genotype Status

NCT00749853 | Suspended Phase 3

• 1 other identifier: ufktem1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Available data from in vitro studies and clinical trials indicate that genetic factors play a significant role in the success of controlled ovarian stimulation (COS) prior to in vitro fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype make up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal FSH serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of poor response to COS and cycle cancellation. The investigators therefore intend to perform a study to investigate whether a dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn Ser/Ser genotype is more effective than routine management in terms of

• the mean number of follicles
• the mean number of embryos
• the rate of poor responders
• the rate of women with cycle cancellations, and v) the clinical pregnancy rates. Eligible women will be randomized to a stimulation protocol characterised by a longer duration and increased dosage of FSH stimulation (group A) or a standard stimulation protocol (group B).

Conditions

Sterility

Keywords

ovarian stimulation; FSH; genotyping; polymorphism

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  3 months

Secondary Outcomes (1)

• follicle count, cycle cancellation rate, poor responder rate

  2 months

Study Arms (2)

1

EXPERIMENTAL

Pituitary down-regulation will be achieved using buserelin (Suprefact®, Hoechst, Frankfurt, Germany) at a fixed daily dose of 200 mg s.c., according to a long agonist protocol, starting on day 2 of the normal menstrual cycle. Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations \<200 pmol/l and no follicles \>15 mm in diameter or ovarian cysts on ultrasonographic examination. The initial r-hFSH dose will be 250 IU s.c. daily for 5 days, after which the dose will be increased to a maximum of 450 IU per day using a step-up protocol with steps of 50 IU/day.

Drug: follicle stimulating hormone

2

ACTIVE COMPARATOR

No pituitary down-regulation will be performed. Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations \<200 pmol/l and no follicles \>15 mm in diameter or ovarian cysts on ultrasonographic examination. The r-hFSH dose will be 150 IU s.c. daily for 11 consecutive days.

Drug: follicle stimulating hormone

Interventions

follicle stimulating hormone DRUG

Pituitary down-regulation will be achieved using buserelin (Suprefact®, Hoechst, Frankfurt, Germany) at a fixed daily dose of 200 mg s.c., according to a long agonist protocol, starting on day 2 of the normal menstrual cycle. Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations \<200 pmol/l and no follicles \>15 mm in diameter or ovarian cysts on ultrasonographic examination. The initial r-hFSH dose will be 250 IU s.c. daily for 5 days, after which the dose will be increased to a maximum of 450 IU per day using a step-up protocol with steps of 50 IU/day.

Also known as: buserelin, r-hFSH, r-hLH

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40
• Informed consent
• Indication for IVF-ET

You may not qualify if:

• Inability to understand written informed consent form
• Personal history of ovarian hyperstimulation syndrome

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

University of Vienna

Vienna, Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Infertility

Interventions

Follicle Stimulating Hormone; Buserelin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Johannes C. Huber, MD, PhD

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Clemens Tempfer, MD

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: May 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

AU (1)