BridgeMD
Finding the optimal dosing of recombinant FSH
EU CTIS ID: 2024-517312-30-00
What this study is testing
Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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
You likely can't join if
- • 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
See the full eligibility 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
- • 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.