There are 5 clinical trials
The aim is to be able to predict the hormonal response according to gonadotropin receptor genotype and hormone type used for treatment of women undergoing in vitro fertilization or egg donation. Outcome will be measured as pregnancy success, live born babies and unwanted side effects.
This assumption is supported by a recent study on more than 600 women undergoing in vitro fertilization, demonstrating that whereas only 10% of women with asparagine in both genes (FSHR N680S and LHR N312S) became pregnant, 40% of those with serine did (Lindgren I et al. --- N680S ---
Description: Association between pregnancy rate and genotype is evaluated
Measure: Pregnancy Time: up to 12 months after treatmentDescription: Number of eggs developed in response to drug according to genotype is measured
Measure: Number of oocytes Time: up to 6 months after treatmentDescription: Live birth rate according to genotype is analyzed
Measure: live birth Time: up to 12 months after treatmentDescription: Association between overreaction to hormonal stimulation and genotype is analysed
Measure: Ovarian hyper stimulation syndrome Time: Up to 6 months after treatmentDescription: No or poor development of eggs in response to drug is analysed, genotype taken into account
Measure: Poor response Time: Up to 6 months after treatmentThis 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.
Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation. --- N680S ---
N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS 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. --- N680S ---
N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS 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. --- N680S --- --- N680S ---
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. --- N680S ---
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).. Genotype of the N680S polymorphism of the FSHR gene. --- N680S ---
Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples. --- N680S ---
Inclusion criteria: - Signature of Informed Consent - Age ≤ 37 years - BMI < 30 kg/m2 - Antral follicles count 1st cycle COS = 5-15 - Antimüllerian hormone basal 1st cycle COS > 1,1 ng/ml and < 3,1 ng/ml - COS protocol: equal starting dose in the 2 cycles of COS (150-225 UI/day) with dose adjustment from the 5th day of COS; pituitary suppression protocol in the 2 cycles of COS with GnRH antagonist with onset when ≥ 1 follicle of ≥ 14 mm in diameter or E2 ≤ 600 pg/ml; and triggering with hCGr or GnRH agonist - Optional the use of oral contraceptives (OC) (however, same in the 2 cycles) - 4-9 recovered oocytes in the 1st cycle of COS - ≤ 6 months between the 2 cycles of COS Exclusion criteria: - Use of the LH activity during the cycles of COS - Presence of severe male factor - Grade III-IV endometriosis - Patients with polycystic ovary syndrome, a history of uterine or ovarian surgeries, hydrosalpinx visible by ultrasound, or uterine fibroids measuring > 30 mm - Major systemic or uncontrolled endocrine-metabolic diseases affecting the pituitary gland, the thyroid gland, the adrenal glands, the pancreas, the liver, or the kidneys Inclusion criteria: - Signature of Informed Consent - Age ≤ 37 years - BMI < 30 kg/m2 - Antral follicles count 1st cycle COS = 5-15 - Antimüllerian hormone basal 1st cycle COS > 1,1 ng/ml and < 3,1 ng/ml - COS protocol: equal starting dose in the 2 cycles of COS (150-225 UI/day) with dose adjustment from the 5th day of COS; pituitary suppression protocol in the 2 cycles of COS with GnRH antagonist with onset when ≥ 1 follicle of ≥ 14 mm in diameter or E2 ≤ 600 pg/ml; and triggering with hCGr or GnRH agonist - Optional the use of oral contraceptives (OC) (however, same in the 2 cycles) - 4-9 recovered oocytes in the 1st cycle of COS - ≤ 6 months between the 2 cycles of COS Exclusion criteria: - Use of the LH activity during the cycles of COS - Presence of severe male factor - Grade III-IV endometriosis - Patients with polycystic ovary syndrome, a history of uterine or ovarian surgeries, hydrosalpinx visible by ultrasound, or uterine fibroids measuring > 30 mm - Major systemic or uncontrolled endocrine-metabolic diseases affecting the pituitary gland, the thyroid gland, the adrenal glands, the pancreas, the liver, or the kidneys In Vitro Fertilization Controlled Ovarian Stimulation 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. --- N680S ---
Description: 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).
Measure: Oocytes retrieved Time: Through study completion, an average of 1 yearDescription: Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples
Measure: Genotype of the N680S polymorphism of the FSHR gene Time: Through study completion, an average of 1 yearDescription: Genotype of the N312S polymorphism of the LHCGR gene will be tested on blood samples
Measure: Genotype of the N312S polymorphism of the LHCGR gene Time: Through study completion, an average of 1 yearAim of study: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.
To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.. polymorphisms in the FSH receptor (FSHR) variant N680S. --- N680S ---
To define the incidence of carriers of polymorphisms in the FSH receptor (FSHR) variant N680S (homozygous and heterozygous) among women undergoing ovarian stimulation for IVF.. polymorphisms in the LH receptor (LHR) variant N312S. --- N680S ---
Description: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.
Measure: Gonadotrophin receptor polymorphisms and ovarian response and AMH value Time: 1 yearDescription: To define the incidence of carriers of polymorphisms in the FSH receptor (FSHR) variant N680S (homozygous and heterozygous) among women undergoing ovarian stimulation for IVF.
Measure: polymorphisms in the FSH receptor (FSHR) variant N680S Time: 1 yearDescription: To define the incidence of carriers of polymorphisms in the LH receptor (LHR) variant N312S (homozygous and heterozygous) among women undergoing ovarian stimulation for IVF.
Measure: polymorphisms in the LH receptor (LHR) variant N312S Time: 1 yearDescription: To analyse the doses of gonadotrophins needed for stimulation on each group of patients
Measure: Doses of gonadotrophin needed and polymorphisms Time: 1 yearTo evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation
Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation prevalence of the main FSH receptor polymorphism. --- ASN680Ser ---
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.
Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH Versus Recombinant FSH in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism. --- N680S ---
Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial) Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism. --- N680S ---
Efficacy of Urinary Vs Recombinant FSH in Oocyte Donors Based on Receptor N680S FSH Gene Polymorphism (Genodon Trial) Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism. --- N680S --- --- N680S ---
Inclusion Criteria: - Be considered eligible to get into the oocyte donation program of Instituto Bernabeu - Age between 18 and 30 years - Body Mass Index over 18 and under 28 - Antral follicle count greater than 9 and less than 25 (adding both ovaries) - Patients starting ovarian stimulation with 225 IU of FSH - Presence of both ovaries - Ability to participate and comply with the study protocol - Signing the written consent form - Not having received treatment with ovulation stimulators in the 3 months prior to stimulation Exclusion Criteria: - Not suitable for inclusion in the oocyte donation program of Institute Bernabeu - Concurrent participation in another study Inclusion Criteria: - Be considered eligible to get into the oocyte donation program of Instituto Bernabeu - Age between 18 and 30 years - Body Mass Index over 18 and under 28 - Antral follicle count greater than 9 and less than 25 (adding both ovaries) - Patients starting ovarian stimulation with 225 IU of FSH - Presence of both ovaries - Ability to participate and comply with the study protocol - Signing the written consent form - Not having received treatment with ovulation stimulators in the 3 months prior to stimulation Exclusion Criteria: - Not suitable for inclusion in the oocyte donation program of Institute Bernabeu - Concurrent participation in another study Reproductive Techniques, Assisted The aim of this study is to determine whether the number of oocytes obtained in women oocyte donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene polymorphism. --- N680S ---
Description: number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation
Measure: number of cumulus-oocyte complexes obtained Time: through study completion, an average of 2 weeksDescription: number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation
Measure: number of metaphase II (MII) oocytes Time: through study completion, an average of 2 weeksDescription: number of useful oocytes after artificial insemination or microinjection
Measure: number of useful oocytes (inseminated or microinjected) Time: through study completion, an average of 2 weeksDescription: mean number of days between the start of ovarian stimulation until the day of the follicular puncture
Measure: duration of stimulation (days) Time: through study completion, an average of 2 weeksDescription: FSH treatment units administrated per oocyte obtained
Measure: FSH treatment units obtained by oocyte Time: through study completion, an average of 2 weeksDescription: FSH treatment cost per oocyte obtained
Measure: FSH treatment cost per oocyte obtained Time: through study completion, an average of 2 weeksDescription: fertilization rate at 18 hours post-insemination
Measure: fertilization rate Time: through study completion, an average of 2 weeksDescription: occurrence of side effects associated with urinary FSH and recombinant FSH
Measure: occurrence of side effects Time: through study completion, an average of 2 weeks