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Using a fixed dosage of follitropin delta for ovarian stimulation for intrauterine insemination. Rekovelle for Intrauterine Successful Experience (RISE )

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520681-22-00
Acronym
RISE
Enrollment
80
Registered
2025-07-31
Start date
2025-12-17
Completion date
Unknown
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm.

Detailed description

Number of follicles ≥14 mm on the day of trigger ( by cycle), Number of follicles between 10 et 13 mm on the day of trigger (by cycle), Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment, Presence or absence of dose adjustment in subsequent cycles, Dose adjustment on subsequent cycle(s) : number and percentage of cycles and quantity of mcg, E2, PG, LH levels on the day of trigger, Frequency of spontaneous LH surge by cycle , at the end of stimulation (last day of stimulation), Cycle cancellation rate (by cycle) . The Cycle is cancelled when more than 2 follicles ≥ 14mm or 4 follicles ≥ 10mm, or if there is no response to treatment, Pregnancy loss rate, Rate of Biochemical pregnancy (βhCG test), Clinical pregnancy, Ongoing pregnancy (by initiated cycle, by insemination and cumulative rates) by patient, Pregnancy rate with one follicle or two follicles diameter ≥14 mm, Multiple pregnancy rate, Time to pregnancy (time between 1st stimulation and date of pregnancy), The number of stimulation days, Unexpected and related Events, Duration in days between each cycle, The duration of stimulation for each cycle, Endometrial thickness, Pregnancy outcome according to the cycle rank, Cumulative pregnancy outcome up to 3 cycles, Number of OHSS, Number of ectopic pregnancy, Number of ovarian torsion, Number of thromboembolic events, Causes of cycle cancellation

Interventions

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm.

Secondary

MeasureTime frame
Number of follicles ≥14 mm on the day of trigger ( by cycle), Number of follicles between 10 et 13 mm on the day of trigger (by cycle), Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation (follicles diameter ≥14 mm) and no follicles between 10 et 13 mm for each cycle and according to dose adjustment, Presence or absence of dose adjustment in subsequent cycles, Dose adjustment on subsequent cycle(s) : number and percentage of cycles and quantity of mcg, E2, PG, LH levels on the day of trigger, Frequency of spontaneous LH surge by cycle , at the end of stimulation (last day of stimulation), Cycle cancellation rate (by cycle) . The Cycle is cancelled when more than 2 follicles ≥ 14mm or 4 follicles ≥ 10mm, or if there is no response to treatment, Pregnancy loss rate, Rate of Biochemical pregnancy (βhCG test), Clinical pregnancy, Ongoing pregnancy (by initiated cycle, by insemination and cumulative rates) by patient, Pregnancy rate wit

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026