Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Other: observation natural cycle; Drug: Agonist GnRH; estradiol Valerate; progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01353846

0901-C-055-MF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Natural cycle

Active Comparator group

Treatment:

Other: observation natural cycle

Artificial cycle

Active Comparator group

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

Treatment:

Drug: Agonist GnRH; estradiol Valerate; progesterone