NCT02915900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

September 21, 2016

Last Update Submit

September 18, 2017

Conditions

Infertility

Keywords

In vitro fertilization

Outcome Measures

Primary Outcomes (2)

  • 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.

    The day of follicle aspiration.

  • 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.

    The day of follicle aspiration.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Gonadotropin removal test

Routine IVF method

ACTIVE COMPARATOR

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

Other: Routine IVF method

Interventions

Gonadotropin removal testOTHER

Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.

Intervention
Routine IVF methodOTHER

Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.

Routine IVF method

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Reproductive Medicine, Oslo University Hospital

Oslo, Norway

Location

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Peter Fedorcsak, MD, PhD

    OUS-HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 27, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

July 1, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

NO(1)