Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

September 18, 2017 updated by: Peter Zoltan Fedorcsak, Oslo University Hospital

Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)

During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.

Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.

In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.

The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Department of Reproductive Medicine, Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol
  • Pre-selected starting dose <110 IU or >270 IU FSH

Exclusion Criteria:

  • Risk for hyperstimulation
  • Polycystic ovary syndrome
  • Endometriosis stage >III
  • BMI>33
  • Anti-mullerian hormone value missing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Hormone dosage is calculated by using the new method Gonadotropin removal test.
Other: Gonadotropin removal test
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
Active Comparator: Routine IVF method
Hormone dosage is chosen by the clinician according to standard clinical routine.
Other: Routine IVF method
Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration
Time Frame: The day of follicle aspiration.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. The mean these differences is compared between treatment and control groups.
The day of follicle aspiration.
Consistency of optimal ovarian response during stimulation.
Time Frame: The day of follicle aspiration.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. Variance of these differences is compared between treatment and control groups.
The day of follicle aspiration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Peter Fedorcsak, MD, PhD, OUS-HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 233978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data might be shared with patient if requested

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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