Infertility Clinical Trial
Official title:
The Performance of an Individual Dosing Regimen of Follitropin Delta for Controlled Ovarian Stimulation for IVF in a Real-word Setting: a Non-interventional Observational Study
As part of the in vitro fertilisation treatment, ovarian stimulation is routinely performed. For this purpose, FSH preparations are used. Follitropin delta is a FSH preparation that is approved for a wide range of applications and is dosed individually according to body weight and serum anti-Müllerian hormone (AMH). Body weight is used to estimate the distribution volume of the glycoprotein FD in the patient and is thus a proxy of exposure. The AMH is used to estimate the ovarian reserve and thus the number of follicles in the ovaries that can be recruited by Follitropin delta stimulation. An algorithm is used for individual dosing. The aim of individual dosing is to reduce the probability of an under or overreaction of the ovaries to FSH therapy. In contrast to phase III registration studies, patients with severe overweight and underweight, as well as very high and very low AMH values and associated disorders of the menstrual cycle and oocyte maturation, are also found in the reality of care. The performance of the dosing algorithm and thus the results of ovarian stimulation in these subgroups of patients have so far been insufficiently investigated in the phase III registration trials. In the present study no statistical hypothesis will be tested. The study is descriptive by design and the analyses are descriptive and exploratory. NIS is chosen in order to explore how the individualized dosing regimen of REKOVELLE® performs in routine clinical practice and to investigate the effectiveness and safety of REKOVELLE® under real-world conditions. This is a monocentric, prospective, non-interventional cohort study conducted in normal care setting in a fertility clinic that will collect information from 850 women undergoing up to two cycles of IVF or ICSI treatment with controlled ovarian stimulation with REKOVELLE®.
Status | Recruiting |
Enrollment | 850 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - Age =18 to = 44 years at enrolment - Planned stimulation in a fixed or flexible GnRH antagonist protocol - Planned use of follitropin delta for ovarian stimulation as per SmPC - Planned IVF or ICSI treatment with ejaculated or cryopreserved male germ cells, autologous or heterologous, with or without planned genetic testing of the oocytes or embryos - Planned preservation of MII oocytes (fertility preservation) - Planned triggering of final oocyte maturation with hCG or a GnRH agonist - Willingness and consent to participate Exclusion Criteria: - Serum AMH within 12 months prior to treatment =0.3 ng/ml - Most recent serum AMH value before start of stimulation older than 12 months - Serum AMH value not determined in Roche Elecsys immunoassays - Pre-treatment with a combined oral contraceptive "pill" consisting of ethinyl estradiol and a synthetic progestogen |
Country | Name | City | State |
---|---|---|---|
Germany | University of Luebeck | Luebeck | Schleswig-Holstein |
Lead Sponsor | Collaborator |
---|---|
University of Luebeck |
Germany,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovarian response | Number of cumulus-oocyte-complexes of the individual dosing regimen of follitropin delta for controlled ovarian stimulation for in-vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) in a cohort of patients from a real-world setting with focus on high body weight. | 2021-2022 | |
Secondary | Overall treatment outcome | Incidence of live birth stratified for low, normal and high AMH and body weight | 2021-2022 | |
Secondary | Change in body weight | Determine change in body weight between 1st and 2nd cycle in subjects undergoing two cycles | 2021-2022 | |
Secondary | Incidence of dose changes | Incidence of dose changes between 1st and 2nd treatment cycle in subjects undergoing two cycles | 2021-2022 | |
Secondary | Intra-individual variation of ovarian response | Intra-individual variation of the number of cumulus-oocyte-complexes retrieved between 1st and 2nd treatment cycle in subjects undergoing two cycles, stratified for low, normal and high AMH and body weight and cycle regularity | 2021-2022 | |
Secondary | Measurement of correlation of variance of body weight and AMH | Correlation coefficient of variance of body weight and AMH with variance of ovarian response between 1st and 2nd cycle in subjects undergoing two cycles | 2021-2022 | |
Secondary | Comparison of intra-individual variance | Intra-individual variance in the number of cumulus-oocyte-complexes retrieved between first and second cycle in subgroups on the prospectively collected data and historical controls | 2021-2022 | |
Secondary | Safety of treatment | Incidence of adverse events related to treatment and assessed by CTCAE v4.0 of follitropin delta in a real-world setting | 2021-2022 | |
Secondary | Change in AMH | Difference in serum AMH values between 1st and 2nd cycle in subjects undergoing two cycles | 2021-2022 |
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