Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Phase 4

• Conditions: Infertility
• Interventions: Other: observation natural cycle; Drug: Agonist GnRH; estradiol Valerate; progesterone

• Registration Number: NCT01353846
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-02
• Primary Completion: 2012-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Natural cycle	observation natural cycle	-
Artificial cycle	Agonist GnRH; estradiol Valerate; progesterone	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

Primary Outcome Measures

Name	Time	Method
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.	12 months	Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain