Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Routine IVF method; Other: Gonadotropin removal test

• Registration Number: NCT02915900
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Primary Completion: 2016-12
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine IVF method	Routine IVF method	Hormone dosage is chosen by the clinician according to standard clinical routine.
Intervention	Gonadotropin removal test	Hormone dosage is calculated by using the new method Gonadotropin removal test.

Primary Outcome Measures

Name	Time	Method
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration	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.
Consistency of optimal ovarian response during stimulation.	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.

Trial Locations

Locations (1)

Department of Reproductive Medicine, Oslo University Hospital; 🇳🇴 Oslo, Norway