Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

University of Oslo (UIO)

Status: Completed

Conditions: Infertility

Treatments: Other: Gonadotropin removal test; Other: Routine IVF method

Study type: Interventional

Funder types: Other

Identifiers

NCT02915900

233978

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Gonadotropin removal test

Routine IVF method

Active Comparator group

Description:

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

Treatment:

Other: Routine IVF method