RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of the randomised controlled study (RCT) is to identify novel strategies that can improve the luteal phase endocrinology after ovarian stimulation, with the aim of using less or no luteal support in IVF while making the endometrium thinner and more receptive to embryo implantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicholas Macklon
• Collaborators: Gedeon Richter Ltd.; Igenomix
• Treatments: Aromatase Inhibitors; Letrozole

Criteria

Inclusion Criteria:

• Meet the clinical criteria for acceptance as oocyte donors (healthy women who volunteers to donate oocytes to other women).

• Regular ovulatory cycle of 26-32 days.

• Age: 18-35 years old.

• Written consent.

Exclusion Criteria:

• Contraindications for ovarian stimulation or aspiration of oocytes according to local guidelines

• Polycystic Ovary Syndrome (PCOS)

• Allergy towards study drug

• Women who have had a hormone or copper intra-uterine device (IUD) within 3 months

Exclusion of patients after earlier inclusion in the study in case of

• Patient withdrawal of consent

• Lack of compliance with medication

• Medical complication arising from IVF treatment that requires the cycle to be terminated

• Serious adverse events (SAE) or serious adverse reactions (SAR) including severe allergy to study drug.

• Specific ARs to study drug: severe degree of hot flushed, severe degree of nausea/vomiting, severe diarrhea, severe degree of muscle and joint pain.

In case of exclusion of a patient after earlier inclusion in the study, a new patient will be included.