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Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

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ClinicalTrials.gov Identifier: NCT02915900
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Zoltan Fedorcsak, Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Infertility Other: Gonadotropin removal test Other: Routine IVF method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)
Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915900


Locations
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Norway
Department of Reproductive Medicine, Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Peter Fedorcsak, MD, PhD OUS-HF

Additional Information:
patent  This link exits the ClinicalTrials.gov site

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Responsible Party: Peter Zoltan Fedorcsak, Head of Department, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02915900     History of Changes
Other Study ID Numbers: 233978
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data might be shared with patient if requested
Keywords provided by Peter Zoltan Fedorcsak, Oslo University Hospital:
In vitro fertilization
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs