An observational study in In Vitro Fertilization and Controlled Ovarian Stimulation, sponsored by Angelini Farmacéutica. Status unknown at 12 sites in Spain. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by Angelini Farmacéutica (part of Angelini Pharma) · Observational
This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation.
It is a non-interventional, observational, cross-sectional and retrospective, national and multicenter study, in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months.
The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used (human FSH and recombinant FSH) in patients undergoing two consecutive cycles of IVF/ICSI with controlled ovarian stimulation.
All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital. The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation.
In order to avoid any bias, the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS (i.e., half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH; and, conversely, the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH). In order to avoid potential modifications to the inclusion criteria, the time elapsed between the two cycles should not exceed 6 months.
Angelini Farmacéutica is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing two cycles of IVF/ICSI who achieved a suboptimal response after the 1st cycle, did not become pregnant, and consequently underwent another cycle of COS in which the protocol was amended during the 2nd cycle to change the nature of the FSH used during the 1st cycle.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oocytes retrieved
Number of oocytes retrieved in each IVF/ICSI cycle with controlled ovarian stimulation used different nature of the FSH in each one (human FSH and recombinant FSH).
Time frame: Through study completion, an average of 1 year
Genotype of the N680S polymorphism of the FSHR gene
Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples
Time frame: Through study completion, an average of 1 year
Genotype of the N312S polymorphism of the LHCGR gene
Genotype of the N312S polymorphism of the LHCGR gene will be tested on blood samples
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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