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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003779-31 | EudraCT Number |
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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.
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.
This is an exploratory, prospective, randomized, comparative, open trial with control group treated according to the usual therapeutic approach in our institution for ovarian stimulation for oocyte donors prospective exploratory study control group .
Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor members of each group will be randomly assigned to receive daily 225 IU of recombinant or urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid unintentional bias, allocation to treatment group will take place at the time in which ovarian stimulation according begins with a list of random allocation of treatments for each of the groups (SS , SN and NN) that will be associated the code of the patient and are prepared and will be available before the start of the study. The code assignment and treatment of the patient will consecutively in the order of the list and must be recorded in the medical history of the patient. The next scheduled patient will be assigned to the code and the next immediate treatment in this list.
The protocol for controlled ovarian stimulation in oocyte donors, will be performed always according to the usual protocol in the Instituto Bernabeu.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urinary follicle-stimulating hormone | Experimental | Controled Ovarian stimulation with urinary follicle-stimulating hormone |
|
| Recombinant follicle-stimulating hormone | Experimental | Ovarian stimulation with recombinant follicle-stimulating hormone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary follicle-stimulating hormone | Drug | Ovarian stimulation with highly purified urinary follicle-stimulating hormone |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of cumulus-oocyte complexes obtained | number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation | through study completion, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| number of metaphase II (MII) oocytes | number of metaphase II (MII) oocytes obtained by follicle puncture at the end of ovarian stimulation | through study completion, an average of 2 weeks |
| number of useful oocytes (inseminated or microinjected) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquín Llácer | Contact | 965 154 000 | jllacer@institutobernabeu.com |
| Name | Affiliation | Role |
|---|---|---|
| Joaquín Llácer | Instituto Bernabeu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Recruiting | Alicante | 03016 | Spain |
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| Recombinant follicle-stimulating hormone | Drug | Controled ovarian stimulation with recombinant follicle-stimulating hormone |
|
|
number of useful oocytes after artificial insemination or microinjection
| through study completion, an average of 2 weeks |
| duration of stimulation (days) | mean number of days between the start of ovarian stimulation until the day of the follicular puncture | through study completion, an average of 2 weeks |
| FSH treatment units obtained by oocyte | FSH treatment units administrated per oocyte obtained | through study completion, an average of 2 weeks |
| FSH treatment cost per oocyte obtained | FSH treatment cost per oocyte obtained | through study completion, an average of 2 weeks |
| fertilization rate | fertilization rate at 18 hours post-insemination | through study completion, an average of 2 weeks |
| occurrence of side effects | occurrence of side effects associated with urinary FSH and recombinant FSH | through study completion, an average of 2 weeks |
| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050477 | Urofollitropin |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| ID | Term |
|---|---|
| D008596 | Menotropins |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006063 | Chorionic Gonadotropin |
| D005640 | Follicle Stimulating Hormone |
| D007986 | Luteinizing Hormone |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
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