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Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
observation natural cycle
Agonist GnRH; estradiol Valerate; progesterone
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring oocyte donation program, natural cycle, hormone replacement therapy

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IVI ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Natural cycle

Artificial cycle

Arm Description

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

Outcomes

Primary Outcome Measures

Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2011
Last Updated
March 30, 2012
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT01353846
Brief Title
Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
Official Title
Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
oocyte donation program, natural cycle, hormone replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Natural cycle
Arm Type
Active Comparator
Arm Title
Artificial cycle
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
observation natural cycle
Other Intervention Name(s)
Control group with natural menstration cycle.
Intervention Description
The patients natural reproductive cycle will be observed and compared to the second arm.
Intervention Type
Drug
Intervention Name(s)
Agonist GnRH; estradiol Valerate; progesterone
Other Intervention Name(s)
Decapeptyl (IPSEN)3.75 mg., Progynova 1 mg (Bayer Schering Farma), Natural micronized progesterone 400 mg/12 hours
Intervention Description
Medications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration
Primary Outcome Measure Information:
Title
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
Description
Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dra. Pilar Alamá
Phone
+34963050900
Email
pilar.alama@ivi.es
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Atkinson
Phone
+34963050900
Email
leslie.atkinson@ivi.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dra. Pilar Alamá, MDPhD
Organizational Affiliation
IVI Valencia
Official's Role
Study Director
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Atkinson, MA
Phone
+34963050900
Email
leslie.atkinson@ivi.es
First Name & Middle Initial & Last Name & Degree
Marcos Ferrando, MD

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

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