Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Normo-ovulatory patients

18 - 38 included years old

BMI between 18 and 29 included kg/m²

Regular menstrual cycles

Disqualifiers

Endometriosis Stage III

Total mobile sperm count <1 million

Severe spermatogenesis disorders

Women with Poly Cystic Ovary Syndrom

Trial design

Design model

Single group

Treatments tested in this trial

  • REKOVELLE (Follitropin Delta)

    Drug

    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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Rekovelle ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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)
2

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)
3

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
4

Presence or absence of dose adjustment in subsequent cycles

Presence or absence of dose adjustment in subsequent cycles

Time frame
up to 9 months

Other outcomes

Sponsors and contacts

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Centre Hospitalier Intercommunal Creteil

Lead sponsor

Ferring Pharmaceuticals

Collaborator