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Polycystic Ovary Syndrome (PCOS) and In Vitro Fertilization (IVF): A Comparison Between Standard Long Protocol Versus an Antagonist Protocol Starting on Day 1

NCT00883766 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-07-20

No results posted yet for this study

Summary

The aim of this study is to compare two different IVF-stimulation protocols in patients affected by PCOS: the use of a Gonadotropin-releasing hormone (GnRH) - antagonist starting on day 1 of controlled ovarian hyperstimulation (COH) versus a standard long agonist protocol; in order to assess whether it affects the number and quality of Metaphase II (MII) oocytes while reducing the risk of hyperstimulation. Since PCOS patients are also likely to be insulin resistant we also aim to evaluate how metformin affects tha IVF stimulation outcome.

Conditions

  • Polycystic Ovary Syndrome
  • In Vitro Fertilization

Interventions

OTHER

Controlled ovarian hyperstimulation for IVF with a long agonist protocol

Day 1 of 1st menstruation: OC for 18-21 days (Microdiol ®) + Metformin (Dianben ®) 850 x 2/day if: BMI\>30, HOMA \>3.8, G/I ratio \<4.5 Day 18-24 of cycle: Leuprorelin (Procrin ®) 0.1 s.c. for 14-21 days Day 1 of 2nd menstruation (=Day 1 COH cycle): Hormonal profile (FSH, LH, E2, Pg, T, SHBG), Ultrasonography to exclude cyst \>10 mm Day 2of COH cycle: rFSH (Gonal F ®) 150 IU/day for 4 days; Leuprorelin (Procrin ®) 0.1 s.c. (and following days) Day 7 of COH (and following): Measure FSH, LH, E2, Pg + Ultrasound Day before HCG: stop rFSH Day HCG: measure FSH, LH, E2, Pg, administer 250 mcg Choriogonadotropin-alfa ( Ovitrelle®) Day of pick-up: Follicular fluid from 1st follicle to be centrifuged and stored at -20°C Day 7 after pick-up: ultrasound, patient evaluation. Day 14 after pick-up: HCG in blood Day 28 after pick-up: Ultrasound to visualize heart beat if pregnancy test positive (OC= oral contraceptive; COH= Controlled Ovarian Hyperstimulation)

OTHER

Controlled ovarian hyperstimulation for IVF with an antagonist protocol

Day 1 of pre COH-cycle: OC for 18-21 days (Microdiol ®) + Metformin (Dianben ®) 850 x 2/day if: BMI\>30, HOMA \>3.8, G/I ratio \<4.5 Day 3 of free-pill interval: Hormonal profile (FSH, LH, E2, Pg, T, SHBG), Ultrasonography to exclude cyst \>10 mm Day 5 of free-pill interval (=Day 1 COH cycle): Cetrorelix acetate (Cetrotide®) 0.25 mg s.c. + rFSH (Gonal F ®) 150 IU/day (and following days) Day 3-4-10 of COH cycle: measure FSH, LH, E2, Pg + ECO Day before HCG: stop rFSH + cetrorelix Day HCG: measure FSH, LH, E2, Pg, administer 250 mcg Choriogonadotropin-alfa ( Ovitrelle®) Day of pick-up: Follicular fluid from 1st follicle to be centrifuged and stored at -20°C Day 7 after pick-up: ultrasound, patient evaluation. Day 14 after pick-up: HCG in blood Day 28 after pick-up: Ultrasound to visualize heart beat if pregnancy test positive (OC= oral contraceptive; COH= Controlled Ovarian Hyperstimulation)

Sponsors & Collaborators

  • Fundacion Dexeus

    lead OTHER

Principal Investigators

  • Fulvia Mancini, M.D. PhD · Department of Obstetric, Gynecology and Reproductive Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883766 on ClinicalTrials.gov