Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients

NCT01353846 | Unknown Phase 4

• 1 other identifier: 0901-C-055-MF
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

oocyte donation program; natural cycle; hormone replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Natural cycle

ACTIVE COMPARATOR

Other: observation natural cycle

Artificial cycle

ACTIVE COMPARATOR

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

Drug: Agonist GnRH; estradiol Valerate; progesterone

Interventions

observation natural cycle OTHER

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

Also known as: Control group with natural menstration cycle.

Natural cycle

Agonist GnRH; estradiol Valerate; progesterone DRUG

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

Also known as: Decapeptyl (IPSEN)3.75 mg., Progynova 1 mg (Bayer Schering Farma), Natural micronized progesterone 400 mg/12 hours

Artificial cycle

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• infertile females with preserved gonadal function
• ages 18 - 44 years old included
• first oocyte donation cycle

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46015, Spain

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Control Groups; Estradiol; Progesterone; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Dra. Pilar Alamá, MDPhD

  IVI Valencia

  STUDY DIRECTOR

Central Study Contacts

Dra. Pilar Alamá

CONTACT

+34963050900; pilar.alama@ivi.es

Leslie Atkinson

CONTACT

+34963050900; leslie.atkinson@ivi.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 16, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

ES (1)