Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

March 30, 2012 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • Recruiting
        • IVI Valencia
        • Contact:
        • Sub-Investigator:
          • Marcos Ferrando, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

  • Study Director: Dra. Pilar Alamá, MDPhD, IVI Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (ESTIMATE)

May 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0901-C-055-MF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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