Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles (RIOT-B)

Sven O. Skouby

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Placebo; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT02939898

RIOTB2015

2015-005683-41 (EudraCT Number)

H-15021852 (Other Identifier)

HGH-2016-033_I-Suite: 04482 (Other Identifier)

Details and patient eligibility

About

The goal of this project is to identify autocrine, paracrine and endocrine factors which are associated with intercycle variation in cyclical follicle recruitment.

Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or placebo during ovarian stimulation.

Full description

The primary aim of this project is to explore the putative cyclic recruitment 'gatekeeping' functions of gonadotropins, sex steroids, anti-muellarian hormone and pregnancy associated plasma protein A in normal ovulatory cycles, and the impact of ovarian stimulation on cyclic follicle recruitment in the following cycle.

It is further proposed that supra-physiological levels of estradiol and progesterone which arise from ovarian stimulation may modulate the size of the secondarily recruited follicle cohort in the next cycle. In order to explore the relative contribution of sex steroids as determinants of the size of the next cycle 'wave' of recruitment further, a second aim of this study will be investigate whether limiting the rise in sex steroid levels during ovarian stimulation, by co-treatment with aromatase inhibitor impacts on cyclic recruitment.

Enrollment: 33 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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 years
• AMH 8-32 (both included)
• Written consent
• Willing to undergo intensive monitoring in a natural cycle (the cycle prior to the monitored natural cycle must be hormone treatment free), stimulated cycle and follow up in the subsequent cycle

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

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33 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 International Units of recFSH

Treatment:

Drug: Placebo

Letrozole

Active Comparator group

Description:

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

Treatment:

Drug: Letrozole