Finding the optimal dosing of recombinant FSH

Phase 4

Recruiting

• Conditions: Subfertility in need of ICSI treatment

• Registration Number: 2024-517312-30-00
• Lead Sponsor: UZ Brussel

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Female
• Target Recruitment: 261

Inclusion Criteria

• Female age: > 18 to < 40 years

• No hormonal pre-treatment within the month before the start of the treating cycle

• Signed informed consent

• 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)

• BMI ≤29 Kg /m2

• Patients of ≤ 36 years old, body weight should be >60kg

• Patients of >36 years old, body weight should be > 50 kg

• Regular normo-ovulatory menstrual cycles (26–35 days)

• 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

• Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)

• AFC >7 and < 20

Exclusion Criteria

• Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification(2018)

• Oocyte donors

• 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)

• Endometriosis ≥ grade 3

• Contraindications to the use of gonadotropins

• Abnormal vaginal bleeding of unknown cause

• 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)

• A history of recurrent miscarriage (three or more consecutive miscarriages)

• Surgical obtained sperm (TESE and FNA)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean serum P level on trigger day		Mean serum P level on trigger day

Secondary Outcome Measures

Name	Time	Method
Live birth rate		Live birth rate
Number of COCs retrieved		Number of COCs retrieved
Number of patients who underwent FA		Number of patients who underwent FA
Clinical pregnancy rate		Clinical pregnancy rate
Ongoing pregnancy rate		Ongoing pregnancy rate
Miscarriage rate		Miscarriage rate

Trial Locations

Locations (3)

Algemeen Ziekenhuis Jan Palfijn Gent; 🇧🇪 Gent, Belgium

UZ Brussel; 🇧🇪 Jette, Belgium

Hopital Erasme; 🇧🇪 Anderlecht, Belgium

Algemeen Ziekenhuis Jan Palfijn Gent

🇧🇪Gent, Belgium

Wim Decleer

Site contact

+3292248851

wim.decleer@janpalfijngent.be