Infertility
Conditions
Interventions
Trade Name: Gonal-F
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Follitropin alfa
CAS Number: 56832-30-5
Concentration unit: IU/ml international unit(s)/millilitr
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subfertility/infertility Age =35 = 40 years Undergoing ICSI BMI = 19 and = 30 kg/m² AMH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Endometriosis > rAFS grade II Testicular sperm extraction Recurrent miscarriage (>2 previous miscarriages) Ovarian stimulation for pre-implantation genetic testing (PGT-A/M) Medical/social oocyte vitrification In vitro maturation (IVM) Untreated auto-immune, endocrine, or metabolic disorders Asherman’s syndrome Medical history of coagulopathies Severe OHSS in a previous treatment cycle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this trial is to assess the differences in endometrial gene expression profiles of ovarian stimulation with recombinant hFSH versus both recombinant hFSH and hLH in poor responder patients ;Secondary Objective: The secondary objectives are: -To evaluate the differences in histologic analysis of the endometrium, based on the Noyes’ criteria. -To evaluate if there is a difference in the number of preovulatory follicles, number of MII oocytes, number of oocytes fertilized, number of good quality embryos and total dose of gonadotropins administered. -To compare clinical outcomes in both groups, including implantation rate, clinical pregnancy rate and live birth rate. The exploratory objectives are -To study the differences of genes expression of cumulus cells (CC) be-tween both stimulation groups using full transcriptome analysis. -To study the differences of gene expression of cumulus cells in relation to embryo development using the same transcriptome data. -To evaluate the effect of LH supplementation on the endocrine profile in blood and follicular fluid (FF) ;Primary end point(s): The primary endpoint of the study is the endometrial gene expression profile (using RNAseq) on the 7th day after oocyte maturation trigger .;Timepoint(s) of evaluation of this end point: The endometrial biopsy will be taken 7 days after final oocyte maturation trigger. Gene expression analysis will occur once all samples have been collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Endometrial histologic analysis based on Noyes’ classification system • Progesterone and oestradiol level at oocyte triggering • Number of preovulatory follicles • Number of MII oocytes • Number of fertilized oocytes • Number of good quality embryos • Total dose of gonadotropins administered • Duration of stimulation • Endometrial thickness at the day of endometrial biopsy • Implantation rate • Clinical pregnancy rate • Live birth rate • Cumulus cell (CC) gene expression. • Follicular fluid (FF) endocrine analysis.;Timepoint(s) of evaluation of this end point: 20 months | — |
Countries
Belgium
Contacts
Public ContactStudy Team
UZ Brussel
Outcome results
None listed