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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Other: observation natural cycle
Drug: Agonist GnRH; estradiol Valerate; progesterone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 70
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)
Arms Assigned Interventions
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
Other Names:
  • Decapeptyl (IPSEN)3.75 mg.
  • Progynova 1 mg (Bayer Schering Farma)
  • Natural micronized progesterone 400 mg/12 hours

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353846

Contacts
Contact: Dra. Pilar Alamá +34963050900 pilar.alama@ivi.es
Contact: Leslie Atkinson +34963050900 leslie.atkinson@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Leslie Atkinson, MA     +34963050900     leslie.atkinson@ivi.es    
Sub-Investigator: Marcos Ferrando, MD            
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Study Director: Dra. Pilar Alamá, MDPhD IVI Valencia
  More Information

No publications provided

Responsible Party: Dra. Pilar Alamá, IVI Valencia
ClinicalTrials.gov Identifier: NCT01353846     History of Changes
Other Study ID Numbers: 0901-C-055-MF
Study First Received: May 10, 2011
Last Updated: March 30, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
oocyte donation program
natural cycle
hormone replacement therapy

Additional relevant MeSH terms:
Estrogens
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on May 22, 2013