Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Infertility Clinical Trial

Official title:

Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01353846
• Other study ID #: 0901-C-055-MF
• Status: Recruiting
• Phase: Phase 4
• First received: May 10, 2011
• Last updated: March 30, 2012
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: March 2012
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: Dra. Pilar Alamá
• Phone: +34963050900
• Email: pilar.alama[@]ivi.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• observation natural cycle
The patients natural reproductive cycle will be observed and compared to the second arm.

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

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No