Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915900
• Other study ID #: 233978
• Status: Completed
• Phase: N/A
• First received: September 21, 2016
• Last updated: September 18, 2017
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Norway	Department of Reproductive Medicine, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.

External Links

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