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NCT Number: NCT02915900

Optimising FSH Dosage During in Vitro Fertilization 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Reproductive Medicine, Oslo University Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonadotropin removal test

Other

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

Routine IVF method

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 27, 2016
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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