Trial to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF)… (NCT05499052) | Clinical Trial Compass
CompletedNot Applicable
Trial to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice
Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females aged 18 years or older at enrolment
* Who have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor
* Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label
* Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed
Exclusion Criteria:
* Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated
* Women with a contraindication for prescription of REKOVELLE® treatment
* Hypersensitivity to the active substance or to any of the excipients
* Tumours of the hypothalamus or pituitary gland
* Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
* Gynaecological haemorrhages of unknown aetiology
* Ovarian, uterine, or mammary carcinoma
* Primary ovarian failure
* Malformations of sexual organs incompatible with pregnancy
* Fibroid tumours of the uterus incompatible with pregnancy
* Pregnancy and breast feeding
* Women who undergo ovarian stimulation for fertility preservation
* Women placed under judicial protection, guardianship, or supervision
* Women who are considered as vuln…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)
Timeframe: Up to day 1 of REKOVELLE® stimulation
2
Daily dose of REKOVELLE®
Timeframe: From day 1 up to day 20 of REKOVELLE® stimulation
3
Number of days of treatment with REKOVELLE®
Timeframe: From day 1 up to day 20 of REKOVELLE® stimulation
4
REKOVELLE® Dose changes
Timeframe: From day 1 up to day 20 of REKOVELLE® stimulation
5
Use of the Algorithm dosing Application
Timeframe: Up to day 1 of REKOVELLE® stimulation
6
Use of GnRH protocol for Lutenizing Hormone surge suppression
Timeframe: Up to day 10
7
Type of drug used for triggering of follicle maturation