RIOT STUDY B: MAPPING OF SPECIFIC FACTORS THAT DETERMINE STIMULATION OF THE OVARIES UNDER FERTILITY TREATMENT IN ORDER TO IMPROVE PREGNANCY CHANCE

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: EUCTR2015-005683-41-DK
• Lead Sponsor: Sven O. Skouby, Professor, MD, DMSc. Unit of reproductive Medicine, Herlev/Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-07
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

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 years
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 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

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