Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-10-30

Brief Summary

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This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters during IVF. 128 patients will be randomized to either placebo or active treatment.

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Detailed Description

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The aim of the study is to investigate whether the detrimental effects of ovarian stimulation on outcomes in fresh embryo transfer cycles be ameliorated by co-treatment with aromatase inhibitors? The research questions are:

1. Can the impact of ovarian stimulation on late follicular phase sex steroid levels (and hence endometrial receptivity) be mitigated by co-treatment with aromatase inhibitors during ovarian stimulation?
2. Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactose Monohydrate

2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Adjuvant therapy to recFSH during ovarian stimulation

Letrozole 5mg

2 tablets of 2,5mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

Adjuvant therapy to recFSH during ovarian stimulation

Interventions

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Letrozole

Adjuvant therapy to recFSH during ovarian stimulation

Intervention Type DRUG

Placebo

Adjuvant therapy to recFSH during ovarian stimulation

Intervention Type DRUG

Other Intervention Names

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Aromatase Inhibitor Lactose Monohydrate

Eligibility Criteria

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Inclusion Criteria

* Indication for IVF/ICSI treatment
* Eligible for IVF/ICSI treatment according to local criteria
* Regular cycles 21-35 days (both included)
* Age \< 40
* AMH 8- 32 (both included)
* Written consent

Exclusion Criteria

* Any contraindication for IVF/ICSI treatment according to local criteria
* Previous stimulation for IVF/ICSI with \< 4 oocytes obtained
* PCOS
* Undergoing IVF/ICSI for the purpose of fertility preservation
* Allergy towards study drug

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes