Status:
COMPLETED
RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2
Lead Sponsor:
Nicholas Macklon
Collaborating Sponsors:
Gedeon Richter Ltd.
Igenomix
Conditions:
IVF
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief 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 sup...
Detailed Description
The high estradiol levels generated in IVF by multiple dominant follicles at the follicular-luteal phase transition generate powerful negative feedback at the pituitary gland, effectively switching of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04524026
Start Date
September 18 2018
End Date
November 30 2020
Last Update
January 14 2021
Active Locations (2)
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1
Herlev Hospitals Fertilitetsklinik
Herlev, Denmark, 2730
2
Sjællands Fertilitetsklinik
Køge, Denmark, 4600