FOLLITROPIN DELTA for Infertility

Inclusion criteria

• {"criterion_text":"- Normo-ovulatory patients"}
• {"criterion_text":"- 18 – 38 included years old"}
• {"criterion_text":"- BMI between 18 and 29 included kg/m²"}
• {"criterion_text":"- Regular menstrual cycles"}
• {"criterion_text":"- At least one healthy Fallopian tube"}
• {"criterion_text":"- Normal uterus cavity"}
• {"criterion_text":"- First treatment for IUI"}
• {"criterion_text":"- Affiliation to the social security"}

Exclusion criteria

• {"criterion_text":"- Endometriosis Stage III"}
• {"criterion_text":"- Tumors (including meningioma) whose development is known or suspected to be progesterone-dependent"}
• {"criterion_text":"- History of hepatic dysfunction"}
• {"criterion_text":"- Severe spermatogenesis disorders"}
• {"criterion_text":"- Have been receiving progestogen therapy for more than 6 months"}
• {"criterion_text":"- Known contraindication to hormonal treatments (progestogens or oestrogens), or with a history of adverse events related to their use."}
• {"criterion_text":"- Previous thromboembolism events during or following the use of gonadotrophins or with high risk factors for thromboembolic events (venous or arterial)"}
• {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}
• {"criterion_text":"- High risk of OHSS such as women with AMH ≥ 35 pmol/L"}
• {"criterion_text":"- History of severe uterine malformation (unicornuate or bicornuate uterus)"}
• {"criterion_text":"- Past history of ovarian torsion"}
• {"criterion_text":"- Gynecological bleeding of unknown etiology"}
• {"criterion_text":"- Uncontrolled thyroid dysfunction"}
• {"criterion_text":"- Uncontrolled adrenal dysfunction"}
• {"criterion_text":"- Hydrosalpynx"}
• {"criterion_text":"- Women with Poly Cystic Ovary Syndrom"}
• {"criterion_text":"- Breast pathologies not compatible with gonadotrophin stimulation"}
• {"criterion_text":"- Use of infertility medications that could affect follicle stimulation and maturation such as GH"}
• {"criterion_text":"- History of OHSS or excessive response to gonadotrophins"}
• {"criterion_text":"- Chronic disease with contraindication to ovarian stimulation with gonadotrophins"}
• {"criterion_text":"- Known genetic disease"}
• {"criterion_text":"- Hypothalamus or pituitary tumors"}
• {"criterion_text":"- Ovarian, uterine or breast carcinoma"}
• {"criterion_text":"- Ovarian hypertrophy or ovarian cyst not due to polycystic ovary syndrome"}
• {"criterion_text":"- Not able to understand and sign the written informed consent form"}
• {"criterion_text":"- Previous or current treatment with gonadotrophins"}
• {"criterion_text":"- Primary ovarian failure"}
• {"criterion_text":"- Genital malformations incompatible with pregnancy"}
• {"criterion_text":"- Uterine fibroids incompatible with pregnancy"}
• {"criterion_text":"- Protected persons (pregnant women, nursing mothers, person under guardianship, minors, persons deprived of liberty, and persons unable to give consent)"}
• {"criterion_text":"- Participation in other interventional research"}
• {"criterion_text":"- Total mobile sperm count <1 million"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured at the stage of triggering ovulation: count cycles with exactly two mature follicles (follicle diameter ≥14 mm) across both ovaries and with no follicles measuring between 10 and 13 mm."}

Secondary endpoints

• {"endpoint_text":"- Number of follicles ≥14 mm on the day of trigger ( by cycle)","definition_or_measurement_approach":"Count of follicles with diameter ≥14 mm on day of trigger, reported by cycle."}
• {"endpoint_text":"- Number of follicles between 10 et 13 mm on the day of trigger (by cycle)","definition_or_measurement_approach":"Count of follicles with diameter between 10 and 13 mm on day of trigger, reported by cycle."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"As primary endpoint but analysed per cycle and stratified by whether dose adjustment occurred."}
• {"endpoint_text":"- Presence or absence of dose adjustment in subsequent cycles","definition_or_measurement_approach":"Binary indicator whether dose adjustment occurred in subsequent cycles."}
• {"endpoint_text":"- Dose adjustment on subsequent cycle(s) : number and percentage of cycles and quantity of mcg","definition_or_measurement_approach":"Number and proportion of cycles with dose adjustments and the magnitude of adjustment in micrograms."}
• {"endpoint_text":"- E2, PG, LH levels on the day of trigger","definition_or_measurement_approach":"Measurement of serum estradiol (E2), progesterone (PG), and luteinizing hormone (LH) on day of trigger."}
• {"endpoint_text":"- Frequency of spontaneous LH surge by cycle , at the end of stimulation (last day of stimulation)","definition_or_measurement_approach":"Frequency (per cycle) of spontaneous LH surge measured at end of stimulation (last stimulation day)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Percent of cycles cancelled; cancellation criteria: >2 follicles ≥14 mm or ≥4 follicles ≥10 mm or no response."}
• {"endpoint_text":"- Pregnancy loss rate","definition_or_measurement_approach":"Proportion of pregnancies that end in loss (miscarriage) among detected pregnancies."}
• {"endpoint_text":"- Rate of Biochemical pregnancy (βhCG test), Clinical pregnancy, Ongoing pregnancy (by initiated cycle, by insemination and cumulative rates) by patient","definition_or_measurement_approach":"Rates of biochemical (βhCG), clinical, and ongoing pregnancies reported per initiated cycle, per insemination, and cumulative up to specified cycles."}
• {"endpoint_text":"- Pregnancy rate with one follicle or two follicles diameter ≥14 mm","definition_or_measurement_approach":"Pregnancy rates stratified by having one vs two follicles ≥14 mm."}
• {"endpoint_text":"- Multiple pregnancy rate","definition_or_measurement_approach":"Proportion of pregnancies that are multiple pregnancies."}
• {"endpoint_text":"- Time to pregnancy (time between 1st stimulation and date of pregnancy)","definition_or_measurement_approach":"Time interval from first stimulation to confirmed pregnancy date."}
• {"endpoint_text":"- The number of stimulation days","definition_or_measurement_approach":"Count of days of ovarian stimulation per cycle."}
• {"endpoint_text":"- Unexpected and related Events","definition_or_measurement_approach":"Recording of unexpected adverse events related to treatment."}
• {"endpoint_text":"- Duration in days between each cycle","definition_or_measurement_approach":"Days between end of one cycle and start of the next cycle."}
• {"endpoint_text":"- The duration of stimulation for each cycle","definition_or_measurement_approach":"Duration in days of stimulation per cycle."}
• {"endpoint_text":"- Endometrial thickness","definition_or_measurement_approach":"Ultrasound measurement of endometrial thickness."}
• {"endpoint_text":"- Pregnancy outcome according to the cycle rank","definition_or_measurement_approach":"Pregnancy outcomes analysed by cycle number (rank)."}
• {"endpoint_text":"- Cumulative pregnancy outcome up to 3 cycles","definition_or_measurement_approach":"Cumulative pregnancy rates aggregated up to three cycles."}
• {"endpoint_text":"- Number of OHSS","definition_or_measurement_approach":"Count of ovarian hyperstimulation syndrome events."}
• {"endpoint_text":"- Number of ectopic pregnancy","definition_or_measurement_approach":"Count of ectopic pregnancy events."}
• {"endpoint_text":"- Number of ovarian torsion","definition_or_measurement_approach":"Count of ovarian torsion events."}
• {"endpoint_text":"- Number of thromboembolic events","definition_or_measurement_approach":"Count of thromboembolic events."}
• {"endpoint_text":"- Causes of cycle cancellation","definition_or_measurement_approach":"Categorisation and counts of reasons for cancelling cycles."}

France

Earliest CTIS Part Ii Submission Date

16-06-2025

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

288

Number Of Sites

5

Number Of Participants

80

Primary sponsor

Full Name

Centre Hospitalier Intercommunal Creteil

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Ferring SAS","duties_or_roles":"Source of monetary support","organisation_type":""}