Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: … (NCT07153367) | Clinical Trial Compass
RecruitingPhase 2
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
France80 participantsStarted 2025-12-17
Plain-language summary
The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.
Who can participate
Age range
18 Years – 38 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:
* Normo-ovulatory patients
* 18 - 38 included years old
* BMI between 18 and 29 included kg/m²
* Regular menstrual cycles
* At least one healthy Fallopian tube
* Normal uterus cavity
* First treatment for IUI
* Affiliation to the social security
Exclusion Criteria:
* Endometriosis Stage III
* Total mobile sperm count \<1 million
* Severe spermatogenesis disorders
* Women with Poly Cystic Ovary Syndrom
* History of OHSS or excessive response to gonadotrophins
* Chronic disease with contraindication to ovarian stimulation with gonadotrophins
* Known genetic disease
* Hypothalamus or pituitary tumors
* Ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome
* Gynecological bleeding of unknown etiology
* Ovarian, uterine or breast carcinoma
* Primary ovarian failure
* Genital malformations incompatible with pregnancy
* Uterine fibroids incompatible with pregnancy
* Protected persons (pregnant women, nursing mothers, person under guardianship, minors, persons deprived of liberty, and persons unable to give consent)
* Tumors (including meningioma) whose development is known or suspected to be progesterone-dependent
* History of hepatic dysfunction
* Have been receiving progestogen therapy for more than 6 months
* Known contraindication to hormonal treatments (progestogens or oestrogens), or with a history of adverse events related to their use
* Previous thromboembolism events during or following the use of gonadotrophins or with high risk fa…
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
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation