Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
Recruitment status was: Recruiting
|Infertility||Other: observation natural cycle Drug: Agonist GnRH; estradiol Valerate; progesterone||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients|
- Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up. [ Time Frame: 12 months ]Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Natural cycle||
Other: observation natural cycle
The patients natural reproductive cycle will be observed and compared to the second arm.
Other Name: Control group with natural menstration cycle.
Active Comparator: Artificial cycle
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
Medications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353846
|Contact: Dra. Pilar Alamáemail@example.com|
|Contact: Leslie Atkinsonfirstname.lastname@example.org|
|Valencia, Spain, 46015|
|Contact: Leslie Atkinson, MA +34963050900 email@example.com|
|Sub-Investigator: Marcos Ferrando, MD|
|Study Director:||Dra. Pilar Alamá, MDPhD||IVI Valencia|