Using a fixed dosage of follitropin delta for ovarian stimulation for intrauterine insemination.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Intercommunal Creteil

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

17 Dec 2025 → ongoing

Decision date (initial)

2025-07-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ferring SAS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To observe the effect of a fixed dose of follitropin delta (3.66mcg) on the ovarian response during ovarian stimulation for IUI.

Secondary objectives 1

1. Description of the clinical efficacy, efficiency and safety of follitropin delta for women undergoing IUI cycles.

Conditions and MedDRA coding

Infertility

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Normo-ovulatory patients
2. 18 – 38 included years old
3. BMI between 18 and 29 included kg/m²
4. Regular menstrual cycles
5. At least one healthy Fallopian tube
6. Normal uterus cavity
7. First treatment for IUI
8. Affiliation to the social security

Exclusion criteria 32

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 25

1. Number of follicles ≥14 mm on the day of trigger ( by cycle)
2. Number of follicles between 10 et 13 mm on the day of trigger (by cycle)
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
4. Presence or absence of dose adjustment in subsequent cycles
5. Dose adjustment on subsequent cycle(s) : number and percentage of cycles and quantity of mcg
6. E2, PG, LH levels on the day of trigger
7. Frequency of spontaneous LH surge by cycle , at the end of stimulation (last day of stimulation)
8. 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
9. Pregnancy loss rate
10. Rate of Biochemical pregnancy (βhCG test), Clinical pregnancy, Ongoing pregnancy (by initiated cycle, by insemination and cumulative rates) by patient
11. Pregnancy rate with one follicle or two follicles diameter ≥14 mm
12. Multiple pregnancy rate
13. Time to pregnancy (time between 1st stimulation and date of pregnancy)
14. The number of stimulation days
15. Unexpected and related Events
16. Duration in days between each cycle
17. The duration of stimulation for each cycle
18. Endometrial thickness
19. Pregnancy outcome according to the cycle rank
20. Cumulative pregnancy outcome up to 3 cycles
21. Number of OHSS
22. Number of ectopic pregnancy
23. Number of ovarian torsion
24. Number of thromboembolic events
25. Causes of cycle cancellation

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Intercommunal Creteil

Sponsor organisation

Centre Hospitalier Intercommunal Creteil

Address

40 Avenue De Verdun

City

Creteil

Postcode

94000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Intercommunal Creteil

Contact name

Nicolas CHEVALIER

Public contact point

Organisation

Centre Hospitalier Intercommunal Creteil

Contact name

DRSI CHIC

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications