Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sven O. Skouby
• Collaborators: Copenhagen University Hospital, Denmark; Region Capital Denmark; Rigshospitalet, Denmark
• Treatments: Aromatase Inhibitors; Letrozole

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 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