RIOT STUDY A: IS THERE A BETTER CHANCE OF ACHIEVING PREGNANCY UNDER FERTILIZATION TREATMENT WHEN AN AROMATASE INHIBITOR IS ADDED TO THE TREATMENT?

Phase 1

• Conditions: Infertility; MedDRA version: 20.0Level: LLTClassification code 10016401Term: Female infertility of other specified originSystem Organ Class: 100000004872; MedDRA version: 20.0Level: LLTClassification code 10025511Term: Male infertility, unspecifiedSystem Organ Class: 100000004872; MedDRA version: 20.0Level: LLTClassification code 10016403Term: Female infertility of tubal originSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-005682-24-DK
• Lead Sponsor: Sven Olaf Skouby, Professor, MD, DMSc. Unit of Reproductive Medicine, Herlev/Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-13
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

Indication for IVF/ICSI treatment
Eligible for IVF/ICSI treatment according to local criteria
IVF/ICSI treatment with single embryo transfer
Regular cycles 21-35 days (both included)
Age < 40
AMH 8- 32 (both included)
Written consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

After inclusion the participants will be excluded from further participation in the trial in case of
?Withdrawal of consent
?Lack of compliance with study medication
?Medical complications arising from IVF treatment that would require the cycle to be terminated on clinical grounds
?Serious adverse event or reaction including severe allergy to study drug or developing an excessive response to ovarian hyperstimulation in the follicular phase for which termination of all medication was required.
?Specific adverse reactions to study drug: severe degree of hot flushes, severe degree of nausea/vomiting, severe degree of muscle and joint pain.

Participants who are withdrawn from the study will be replaced by inclusion of new participants.
Should the study participant present with ovarian cyst or inadequate endometrium thickness according to local guidelines on the initial ultrasound scan, the participant will be managed according to local clinical policies. The participant can be randomized when she is considered ready to commence ovarian stimulation according to local protocols.
In case of a low response to stimulation resulting in cancellation of the cycle before oocyte retrieval, or when no embryos are available for transfer, the participant will be withdrawn from further participation. Both instances will be addressed in the report of results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified