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Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

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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
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Other: observation natural cycle Drug: Agonist GnRH; estradiol Valerate; progesterone Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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

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, IVI VALENCIA
Study Director: Dra. Pilar Alamá, MDPhD IVI Valencia
More Information

Responsible Party: Dra. Pilar Alamá, IVI Valencia
ClinicalTrials.gov Identifier: NCT01353846     History of Changes
Other Study ID Numbers: 0901-C-055-MF
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

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

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