Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natural cycle

Group Type ACTIVE_COMPARATOR

observation natural cycle

Intervention Type OTHER

The patients natural reproductive cycle will be observed and compared to the second arm.

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

Group Type ACTIVE_COMPARATOR

Agonist GnRH; estradiol Valerate; progesterone

Intervention Type DRUG

Medications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration

Interventions

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observation natural cycle

The patients natural reproductive cycle will be observed and compared to the second arm.

Intervention Type OTHER

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

Intervention Type DRUG

Other Intervention Names

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Control group with natural menstration cycle. Decapeptyl (IPSEN)3.75 mg. Progynova 1 mg (Bayer Schering Farma) Natural micronized progesterone 400 mg/12 hours

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes