Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.

Detailed Description
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Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness. The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation. The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.

Official Title
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Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Conditions
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Infertility

Intervention / Treatment
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* Other: observation natural cycle
* Drug: Agonist GnRH; estradiol Valerate; progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertile females with preserved gonadal function ages 18 - 44 years old included first oocyte donation cycle Exclusion Criteria: BMI: > 28 recurrent miscarriages (3 or more) recurrent of implantation failure severe male factor important miomas > 44 years old Problems with the drugs used in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 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: Natural cycle<br> | Other: observation natural cycle<br>* The patients natural reproductive cycle will be observed and compared to the second arm.<br>* Other names: Control group with natural menstration cycle.;|
| Active Comparator: Artificial cycle<br>Drugs: Agonist GnRH Acetate Triptoreline Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose. Estradiol Valerate, orally Initially 4 pills daily during 4 days, and after increase the dose to 6 mg orally daily. Natural micronized progesterone, 400 mg/12 hours vaginal administration | Drug: Agonist GnRH; estradiol Valerate; progesterone<br>* Medications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration<br>* Other names: Natural micronized progesterone 400 mg/12 hours;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up. | Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte donation program, natural cycle, hormone replacement therapy