Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

This study is currently recruiting participants.
Verified March 2012 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01353846
First received: May 10, 2011
Last updated: March 30, 2012
Last verified: March 2012

May 10, 2011
March 30, 2012
May 2011
November 2012   (final data collection date for primary outcome measure)
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.
Same as current
Complete list of historical versions of study NCT01353846 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • 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.
  • 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
    Other Names:
    • Decapeptyl (IPSEN)3.75 mg.
    • Progynova 1 mg (Bayer Schering Farma)
    • Natural micronized progesterone 400 mg/12 hours
  • Active Comparator: Natural cycle
    Intervention: Other: observation natural 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

    Intervention: Drug: Agonist GnRH; estradiol Valerate; progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
Yes
Contact: Dra. Pilar Alamá +34963050900 pilar.alama@ivi.es
Contact: Leslie Atkinson +34963050900 leslie.atkinson@ivi.es
Spain
 
NCT01353846
0901-C-055-MF
No
Dra. Pilar Alamá, IVI Valencia
Instituto Valenciano de Infertilidad, Spain
Not Provided
Study Director: Dra. Pilar Alamá, MDPhD IVI Valencia
Instituto Valenciano de Infertilidad, Spain
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP