Finding the optimal dosing of recombinant FSH

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

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

Trial duration

19 Jun 2019 → ongoing

Decision date (initial)

2024-10-04

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517312-30-00

EudraCT number

2018-002000-13

ClinicalTrials.gov

NCT03686852

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy, Efficacy

Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.

Secondary objectives 1

1. Assess the number of retrieved oocytes, number of mature oocytes, number of top quality embryos on Day 3, clinical pregnancy rate (number of viable pregnancies at 6 weeks of gestation per ITT and PP), ongo-ing pregnancy rate (number of viable pregnancies at 12 weeks of gestation per ITT and PP), miscarriage rate and percentage of patients with a P value above 1.5 ng/mL on the day of hCG.

Conditions and MedDRA coding

Subfertility in need of ICSI treatment

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. • Female age: > 18 to < 40 years
2. • The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these at-tempts)
3. • BMI ≤29 Kg /m2
4. • Patients of ≤ 36 years old, body weight should be >60kg
5. • Patients of >36 years old, body weight should be > 50 kg
6. • Regular normo-ovulatory menstrual cycles (26–35 days)
7. • Basal FSH <10 IU/l, basal E2 <60 pg/ml and basal Progesteone (< 1.5 ng/mL) (normal cycle day-3 basal serum hormone levels), to be measured on cycle day 2 or 3 of the treatment cycle
8. • Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)
9. • AFC >7 and < 20
10. • No hormonal pre-treatment within the month before the start of the treating cycle
11. • Signed informed consent

Exclusion criteria 9

1. • Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification(2018)
2. • Oocyte donors
3. • Poor responder patients (defined by the Bologna criteria (Ferraretti et al., 2011): eligible women had to fulfil at least two of the three following criteria: (i) advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (patients with genetic or ac-quired conditions); (ii) poor ovarian response (≤3 oocytes with a conventional stimulation protocol); (iii) abnormal ovarian reserve test (antral follicle count [AFC] <7 or anti-Müllerian hormone [AMH] <1.1 ng/ml). follow up)
4. • Endometriosis ≥ grade 3
5. • Contraindications to the use of gonadotropins
6. • Abnormal vaginal bleeding of unknown cause
7. • History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteristics)
8. • A history of recurrent miscarriage (three or more consecutive miscarriages)
9. • Surgical obtained sperm (TESE and FNA)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean serum P level on trigger day

Secondary endpoints 6

1. Number of COCs retrieved
2. Number of patients who underwent FA
3. Clinical pregnancy rate
4. Ongoing pregnancy rate
5. Miscarriage rate
6. Live birth rate

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Prof. Dr. Christophe Blockeel

Public contact point

Organisation

UZ Brussel

Contact name

Elsie Nulens

Locations

1 EU/EEA country · 3 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 14 files

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

Application history

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