A Phase 2 interventional study of REKOVELLE (Follitropin Delta) in Infertility and Insemination, sponsored by Centre Hospitalier Intercommunal Creteil. Recruiting at 5 sites in France. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Centre Hospitalier Intercommunal Creteil · Phase 2, Interventional, and Treatment
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.
Intrauterine insemination (IUI) is a frequently used step in the management of unexplained infertility or mild fertility disorders. In normal-weight patients, the main objective of ovarian stimulation in IUI is to obtain a controlled ovarian response, ideally bifollicular.
Moreover, the main risks currently associated with IUI are multiple pregnancies and iatrogenic complications (cycle cancellation due to insufficient response or excessive response to stimulation more than 3 follicles). It is therefore essential to optimize stimulation treatment protocols to ensure IUI under the best possible conditions.
Due to a precise dose adjustment with Follitropin Delta, the product used in the study (REKOVELLE), for normo-ovulatory patient, an optimal response (bifollicular response) is expected for the majority of patients from the first stimulation. This goal will also facilitate quicker pregnancy attainment and reduce the risk of drop-out and insémination annulation The hypothesis is that this dosage would be efficient and also minimize the risk of multiple pregnancies During the screening visit, the investigator checks the patient's eligibility and informs her about the RISE study. At the inclusion visit, written informed consent is obtained, and the Rekovelle® treatment is explained and initiated. Monitoring visits start on day 9 and then every 2 days until two mature follicles develop. Ovocyte maturation is triggered with an hCG injection, followed by insemination 24 to 36 hours later, performed according to routine care. Follow-up visits occur at 6-8 weeks and 13 weeks post-insemination.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Drug: REKOVELLE (Follitropin Delta)
Each patient will start the ovarian stimulation with a fixed dose of 3,66 mcg of Rekovelle ® on day 4 of the natural cycle (Stimulation day 1-S1). The stimulation period will last a maximum of 13 days. Patients will be regularly evaluated to monitor the response to stimulation with ultrasound scan and blood sampling
Percentage of cycles with two mature follicles (total of two ovaries) at the stage of triggering ovulation
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.
Time frame: up to 9 months
Number of follicles ≥14 mm on the day of trigger
Number of follicles ≥14 mm on the day of trigger ( by cycle)
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Number of follicles between 10 et 13 mm on the day of trigger
Number of follicles between 10 et 13 mm on the day of trigger (by cycle)
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
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
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
Time frame: up to 9 months
Presence or absence of dose adjustment in subsequent cycles
Presence or absence of dose adjustment in subsequent cycles
Time frame: up to 9 months
E2 level on the day of trigger
E2 level on the day of trigger (pg/ml)
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Dose adjustment on subsequent cycle(s) : quantity of mcg
Dose adjustment on subsequent cycle(s) : quantity of mcg
Time frame: up to 9 months
PG level on the day of trigger
PG level on the day of trigger (ng/ml)
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
LH level on the day of trigger
LH level on the day of trigger (UI/L)
Time frame: Up to Day 15 of the cycle (each cycle is 28 days)
Frequency of spontaneous LH surge by cycle , at the end of stimulation
Frequency of spontaneous LH surge by cycle , at the end of stimulation (last day of stimulation)
Time frame: up to 9 months
Cycle cancellation rate
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.
Time frame: up to 9 months
Pregnancy loss rate
Pregnancy loss rate
Time frame: up to 9 months
Rate of Biochemical pregnancy (βhCG test) by initiated cycle
Rate of Biochemical pregnancy (βhCG test) by initiated cycle
Time frame: From enrollment to 2 weeks after IUI
Rate of Clinical pregnancy by initiated cycle
Rate of Clinical pregnancy by initiated cycle
Time frame: From enrollment to 8 weeks after IUI
Rate of Ongoing pregnancy by initiated cycle
Rate of Ongoing pregnancy by initiated cycle
Time frame: From enrollment to 13 weeks after IUI
Pregnancy rate with one follicle or two follicles diameter ≥14 mm
Pregnancy rate with one follicle or two follicles diameter ≥14 mm
Time frame: up to 9 months
Multiple pregnancy rate
Multiple pregnancy rate
Time frame: up to 9 months
Time to pregnancy
Time to pregnancy (time between 1st stimulation and date of pregnancy)
Time frame: From first stimulation until pregnancy confirmed by HCG > 100 UI/L, assessed up to 6 months.
The number of stimulation days.
The number of stimulation days.
Time frame: up to 9 months
Unexpected and related Events
Unexpected and related Events
Time frame: up to 9 months
Duration in days between each cycle
Duration in days between each cycle
Time frame: up to 9 months
Dose adjustment on subsequent cycle(s) : number of cycles
Dose adjustment on subsequent cycle(s) : number of cycles
Time frame: up to 9 months
Dose adjustment on subsequent cycle(s) : percentage of cycles
Dose adjustment on subsequent cycle(s) : percentage of cycles
Time frame: up to 9 months
Rate of Biochemical pregnancy (βhCG test) by insemination
Rate of Biochemical pregnancy (βhCG test) by insemination
Time frame: From enrollment to 2 weeks after IUI
Rate of Biochemical pregnancy (βhCG test):cumulative rates
Rate of Biochemical pregnancy (βhCG test) : cumulative rates
Time frame: From enrollment to 2 weeks after IUI
Rate of Clinical pregnancy by insemination
Rate of Clinical pregnancy by insemination
Time frame: From enrollment to 8 weeks after IUI
Rate of Clinical pregnancy (cumulative rates)
Rate of Clinical pregnancy (cumulative rates)
Time frame: From enrollment to 8 weeks after IUI
Rate of Ongoing pregnancy by insemination
Rate of Ongoing pregnancy by insemination
Time frame: From enrollment to 13 weeks after IUI
Rate of Ongoing pregnancy: cumulative rates
Rate of Ongoing pregnancy: cumulative rates
Time frame: From enrollment to 13 weeks after IUI
The duration of stimulation for each cycle
The duration of stimulation for each cycle
Time frame: up to 9 months
Endometrial thickness
Endometrial thickness
Time frame: up to 9 months
Pregnancy outcome according to the cycle rank
Pregnancy outcome according to the cycle rank
Time frame: up to 9 months
Cumulative pregnancy outcome up to 3 cycles
Cumulative pregnancy outcome up to 3 cycles
Time frame: up to 9 months
Number of OHSS
Number of OHSS
Time frame: up to 9 months
Number of ectopic pregnancy
Number of ectopic pregnancy
Time frame: up tp 9 months
Number of ovarian torsion
Number of ovarian torsion
Time frame: up to 9 months
Number of thromboembolic events
Number of thromboembolic events
Time frame: up to 9 months
Causes of cycle cancellation
Causes of cycle cancellation
Time frame: up to 9 months
Plan to share: No
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Centre Hospitalier Intercommunal Creteil