NCT00948805

Brief Summary

This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

11 months

First QC Date

July 23, 2009

Last Update Submit

July 28, 2009

Conditions

Infertility

Keywords

corpus luteum rescueGonadotropin Releasing Hormone (GnRH agonist)human Chorionic Gonadotropin (hCG)infertilitypregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Frequency of functional rescue of corpus luteum

    6 months

Secondary Outcomes (3)

  • Pregnancy rate

    6 months

  • Levels of serum steroids

    6 months

  • Levels of serum gonadotropins

    6 months

Study Arms (2)

GnRH agonist

EXPERIMENTAL

3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

Drug: GnRH agonist

Control

ACTIVE COMPARATOR

250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

Drug: Control

Interventions

GnRH agonistDRUG

3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation

Also known as: Ovidrel, Zoladex, Gonal
GnRH agonist
ControlDRUG

250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation

Also known as: Zoladex, Ovidrel, Gonal
Control

Eligibility Criteria

Age21 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age \>21 and \< 38 years old
  • polycystic ovarian syndrome
  • risk for ovarian hyperstimulation syndrome

You may not qualify if:

  • recurrent abortion
  • endometriosis
  • more than 3 IVF failures
  • use of oral contraceptive pills in the preceding 3 months
  • low response to gonadotropins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing HormoneOvidrelGoserelinfollitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Paulo Serafini, PhD

    Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo)

    STUDY CHAIR

Central Study Contacts

Cláudia M Gomes, MD

CONTACT

551130596122cgomes@huntington.com.br

André M Rocha, PhD

CONTACT

551130596122arocha@huntington.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 29, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations

BR(1)