Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment (RIOT-A)

Sven O. Skouby

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Letrozole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02946684

H-15021850 (Other Identifier)

HGH-2016-045_04513 (Other Identifier)

RIOTA2015

2015-005682-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 129 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

129 participants in 2 patient groups, including a placebo group

Lactose Monohydrate

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Letrozole 5mg

Active Comparator group

Description:

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

Treatment:

Drug: Letrozole