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Clinical Trial NCT07153367 (RISE) for Infertility, Insemination is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE) Phase 2 80
Clinical Trial NCT07153367 (RISE) is designed to study Treatment for Infertility, Insemination. It is a Phase 2 interventional study that is recruiting, having started on 17 December 2025, with plans to enroll 80 participants. Led by Centre Hospitalier Intercommunal Creteil, it is expected to complete by 17 March 2028. The latest data from ClinicalTrials.gov was last updated on 12 March 2026.
Brief 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 ...Show More
Detailed Description
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 insuffici...
Show MoreOfficial Title
Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)
Conditions
InfertilityInseminationOther Study IDs
- RISE
NCT ID Number
Start Date (Actual)
2025-12-17
Last Update Posted
2026-03-12
Completion Date (Estimated)
2028-03-17
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalRekovelle Arm | 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | up to 9 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of follicles ≥14 mm on the day of trigger | Number of follicles ≥14 mm on the day of trigger ( by cycle) | 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) | 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 | up to 9 months |
Presence or absence of dose adjustment in subsequent cycles | Presence or absence of dose adjustment in subsequent cycles | up to 9 months |
E2 level on the day of trigger | E2 level on the day of trigger (pg/ml) | 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 | up to 9 months |
PG level on the day of trigger | PG level on the day of trigger (ng/ml) | 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) | 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) | 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. | up to 9 months |
Pregnancy loss rate | Pregnancy loss rate | up to 9 months |
Rate of Biochemical pregnancy (βhCG test) by initiated cycle | Rate of Biochemical pregnancy (βhCG test) by initiated cycle | From enrollment to 2 weeks after IUI |
Rate of Clinical pregnancy by initiated cycle | Rate of Clinical pregnancy by initiated cycle | From enrollment to 8 weeks after IUI |
Rate of Ongoing pregnancy by initiated cycle | Rate of Ongoing pregnancy by initiated cycle | 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 | up to 9 months |
Multiple pregnancy rate | Multiple pregnancy rate | up to 9 months |
Time to pregnancy | Time to pregnancy (time between 1st stimulation and date of pregnancy) | 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. | up to 9 months |
Unexpected and related Events | Unexpected and related Events | up to 9 months |
Duration in days between each cycle | Duration in days between each cycle | up to 9 months |
Dose adjustment on subsequent cycle(s) : number of cycles | Dose adjustment on subsequent cycle(s) : number of cycles | up to 9 months |
Dose adjustment on subsequent cycle(s) : percentage of cycles | Dose adjustment on subsequent cycle(s) : percentage of cycles | up to 9 months |
Rate of Biochemical pregnancy (βhCG test) by insemination | Rate of Biochemical pregnancy (βhCG test) by insemination | From enrollment to 2 weeks after IUI |
Rate of Biochemical pregnancy (βhCG test):cumulative rates | Rate of Biochemical pregnancy (βhCG test) : cumulative rates | From enrollment to 2 weeks after IUI |
Rate of Clinical pregnancy by insemination | Rate of Clinical pregnancy by insemination | From enrollment to 8 weeks after IUI |
Rate of Clinical pregnancy (cumulative rates) | Rate of Clinical pregnancy (cumulative rates) | From enrollment to 8 weeks after IUI |
Rate of Ongoing pregnancy by insemination | Rate of Ongoing pregnancy by insemination | From enrollment to 13 weeks after IUI |
Rate of Ongoing pregnancy: cumulative rates | Rate of Ongoing pregnancy: cumulative rates | From enrollment to 13 weeks after IUI |
The duration of stimulation for each cycle | The duration of stimulation for each cycle | up to 9 months |
Endometrial thickness | Endometrial thickness | up to 9 months |
Pregnancy outcome according to the cycle rank | Pregnancy outcome according to the cycle rank | up to 9 months |
Cumulative pregnancy outcome up to 3 cycles | Cumulative pregnancy outcome up to 3 cycles | up to 9 months |
Number of OHSS | Number of OHSS | up to 9 months |
Number of ectopic pregnancy | Number of ectopic pregnancy | up tp 9 months |
Number of ovarian torsion | Number of ovarian torsion | up to 9 months |
Number of thromboembolic events | Number of thromboembolic events | up to 9 months |
Causes of cycle cancellation | Causes of cycle cancellation | up to 9 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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
- 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 factors for thromboembolic events (venous or arterial)
- Hypersensitivity to the active substance or to any of the excipients
- High risk of OHSS such as women with AMH ≥ 35 pmol/L
- History of severe uterine malformation (unicornuate or bicornuate uterus),
- Past history of ovarian torsion
- Uncontrolled thyroid dysfunction
- Uncontrolled adrenal dysfunction
- Hydrosalpynx
- Breast pathologies not compatible with gonadotrophin stimulation
- Use of infertility medications that could affect follicle stimulation and maturation such as GH
- Participation in other interventional research
- Not able to understand and sign the written informed consent form
Centre Hospitalier Intercommunal CreteilFerring PharmaceuticalsStudy Central Contact
Contact: Aroua Ben Guirat, +33157023710, [email protected]
5 Study Locations in 1 Countries
Cabinet Dr Elodie Descat-Polyclinique Jean Villar, Bruges, 33520, France
Elodie Descat, Dr, Contact, [email protected]
Elodie Descat, Dr, Principal Investigator
Recruiting
Chi Creteil, Créteil, 94000, France
Maud Pasquier, Dr, Contact, 0033 1 57 02 24 70, [email protected]
Maud Pasquier, Dr, Principal Investigator
Recruiting
Cabinet Dr Géraldine PORCU-Institut de Médecine de la Reproduction, Marseille, 13008, France
Géraldine Porcu-Buisson, Dr, Contact, [email protected]
Géraldine Porcu-Buisson, Dr, Principal Investigator
Recruiting
Cabinet Dr Nicolas Chevalier-Centre AMP Saint Roch, Montpellier, 34070, France
Nicolas Chevalier, Dr, Contact, [email protected]
Nicolas Chevalier, Dr, Principal Investigator
Recruiting
Cabinet Dr Nathalie Massin- Hôpital Américain De Paris, Neuilly-sur-Seine, 92200, France
Suspended