Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01353846|
Recruitment Status : Unknown
Verified March 2012 by Instituto Valenciano de Infertilidad, IVI VALENCIA.
Recruitment status was: Recruiting
First Posted : May 16, 2011
Last Update Posted : April 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: observation natural cycle Drug: Agonist GnRH; estradiol Valerate; progesterone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||November 2012|
|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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353846
|Contact: Dra. Pilar Alamáfirstname.lastname@example.org|
|Contact: Leslie Atkinsonemail@example.com|
|Valencia, Spain, 46015|
|Contact: Leslie Atkinson, MA +34963050900 firstname.lastname@example.org|
|Sub-Investigator: Marcos Ferrando, MD|
|Study Director:||Dra. Pilar Alamá, MDPhD||IVI Valencia|