Type of Gonadotropin and Embryo Kinetics of Development

Study Overview
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Brief Summary
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The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.

Official Title
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A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development

Conditions
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Infertility

Intervention / Treatment
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* Drug: Corifollitropin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women <38 years old Weight <60 kg Own oocytes Patients have to provide signed informed consent Exclusion Criteria: Oocyte donors Vitrified oocytes Severe male factor (<1 million spz/ml) Weight >60 kg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corifollitropin alfa<br>Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval. | Drug: Corifollitropin alfa<br> <br> * Other names: Elonva;|
| Active Comparator: recombinant FSH<br>Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes. | Drug: Corifollitropin alfa<br> <br> * Other names: Elonva;|
| Active Comparator: HP- hMG<br>Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval . | Drug: Corifollitropin alfa<br> <br> * Other names: Elonva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T5 defined as the time that embryo needs to reach a 5-cell stage. |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stimulation (days) |  | a month | 
| Total dose of gonadotropins (IU) |  | A month | 
| Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation |  | A month | 
| Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation |  | A month | 
| Levels of progesterone (ng/ml) |  | A month | 
| Fertilization rate |  | A month | 
| Number of embryos transferred and cryopreserved |  | A month | 
| Pregnancy rate |  | A month | 
| Implantation rate |  | A monthe | 
| Miscarriage rate |  | A month | 
| Cancellation rate per cycle initiated |  | A month | 
| Ovarian hyperstimulation syndrome rate |  | A month | 
| Timings of cellular divisions |  | A month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corifollitropin alfa, recombinant FSH, HP-hMG, time-lapse, kinetics of development