search
Back to results

Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Gonadotropin removal test
Routine IVF method
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In vitro fertilization

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Reproductive Medicine, Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Routine IVF method

Arm Description

Hormone dosage is calculated by using the new method Gonadotropin removal test.

Hormone dosage is chosen by the clinician according to standard clinical routine.

Outcomes

Primary Outcome Measures

Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal 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.
Consistency of optimal ovarian response during stimulation.
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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2016
Last Updated
September 18, 2017
Sponsor
Oslo University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02915900
Brief Title
Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)
Official Title
Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In vitro fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Hormone dosage is calculated by using the new method Gonadotropin removal test.
Arm Title
Routine IVF method
Arm Type
Active Comparator
Arm Description
Hormone dosage is chosen by the clinician according to standard clinical routine.
Intervention Type
Other
Intervention Name(s)
Gonadotropin removal test
Intervention Description
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
Intervention Type
Other
Intervention Name(s)
Routine IVF method
Intervention Description
Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
Primary Outcome Measure Information:
Title
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration
Description
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.
Time Frame
The day of follicle aspiration.
Title
Consistency of optimal ovarian response during stimulation.
Description
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.
Time Frame
The day of follicle aspiration.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Fedorcsak, MD, PhD
Organizational Affiliation
OUS-HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Reproductive Medicine, Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data might be shared with patient if requested
Links:
URL
https://www.google.com/patents/WO2013132036A1?cl=en
Description
patent

Learn more about this trial

Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

We'll reach out to this number within 24 hrs