NCT01269125

Brief Summary

The investigators attempted to establish a rationale for the Gonadotropin Releasing Hormone-agonist (GnRH-a) administration, post-laparoscopically, in women with mild endometriosis (until stage II, according to AFS) who underwent IVF-ET procedure. Since GnRH-a reduces cytokine's concentration in serum (Iwabe et al., 1998; Iwabe et al., 2003) and peritoneal fluid of women with endometriosis (Taketani et al., 1992) the investigators hypothesized that GnRH-a can reduces also cytokine's concentration in the follicular fluid and this action may improve the oocyte quality and the fertility of these women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2004

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 24, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

6.3 years

First QC Date

January 3, 2011

Results QC Date

June 29, 2012

Last Update Submit

July 23, 2013

Conditions

EndometriosisInfertility

Keywords

cytokinesendometriosisfertilization ratefollicular fluidpregnancy rate

Outcome Measures

Primary Outcomes (4)

  • Clinical Pregnancy Rate

    Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.

    June 2004-August 2010

  • Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).

    Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with \< 10%, \< 10-20%, \< 20-30% and \>30% fragments were estimated as grade 1,2,3 and 4, respectively.

    June 2004-August 2010

  • Fertilization Rate (Percentage of Fertilized Oocytes).

    The fertilization rate was estimated for every woman 24 hours after oocyte retrieval

    June 2004-August 2010

  • Clinical Pregnancy Rate

    Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.

    4 weeks after a positive pregnancy test

Secondary Outcomes (1)

  • Follicular Fluid's TNF-a Concentration.

    June 2004-August 2010

Study Arms (3)

Endometriosis, leuprolide, IVF

ACTIVE COMPARATOR

Women with stage II endometriosis received GnRH-a (leuprolide) prior to an IVF attempt.

Drug: LeuprolideProcedure: IVF

Endometriosis, IVF

ACTIVE COMPARATOR

Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.

Drug: LeuprolideProcedure: IVF

Tubal infertility, IVF

ACTIVE COMPARATOR

Women with tubal infertility underwent an IVF attempt.

Procedure: IVF

Interventions

LeuprolideDRUG

single injection of 3.75 leuprolide every 28 days, 3 dosages

Also known as: Daronda depot 3.75, Abbott, Hellas
Endometriosis, IVFEndometriosis, leuprolide, IVF
IVFPROCEDURE

Assisted Reproduction Technique.

Endometriosis, IVFEndometriosis, leuprolide, IVFTubal infertility, IVF

Eligibility Criteria

Age29 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertility
  • Mild endometriosis (until stage II)

You may not qualify if:

  • ovarian endometrioma \> 2 cm
  • FSH \> 12 mIU/ml
  • Mail factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Obstetrics & Gynecology, University Hospital

Ioannina, Epirus, 45111, Greece

Location

Related Publications (5)

  • Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.

    PMID: 16437491BACKGROUND

  • Rickes D, Nickel I, Kropf S, Kleinstein J. Increased pregnancy rates after ultralong postoperative therapy with gonadotropin-releasing hormone analogs in patients with endometriosis. Fertil Steril. 2002 Oct;78(4):757-62. doi: 10.1016/s0015-0282(02)03338-1.

    PMID: 12372452BACKGROUND

  • Fedele L, Parazzini F, Radici E, Bocciolone L, Bianchi S, Bianchi C, Candiani GB. Buserelin acetate versus expectant management in the treatment of infertility associated with minimal or mild endometriosis: a randomized clinical trial. Am J Obstet Gynecol. 1992 May;166(5):1345-50. doi: 10.1016/0002-9378(92)91602-7.

    PMID: 1595789BACKGROUND

  • Vercellini P, Crosignani PG, Fadini R, Radici E, Belloni C, Sismondi P. A gonadotrophin-releasing hormone agonist compared with expectant management after conservative surgery for symptomatic endometriosis. Br J Obstet Gynaecol. 1999 Jul;106(7):672-7. doi: 10.1111/j.1471-0528.1999.tb08366.x.

    PMID: 10428523BACKGROUND

  • Kaponis A, Chatzopoulos G, Paschopoulos M, Georgiou I, Paraskevaidis V, Zikopoulos K, Tsiveriotis K, Taniguchi F, Adonakis G, Harada T. Ultralong administration of gonadotropin-releasing hormone agonists before in vitro fertilization improves fertilization rate but not clinical pregnancy rate in women with mild endometriosis: a prospective, randomized, controlled trial. Fertil Steril. 2020 Apr;113(4):828-835. doi: 10.1016/j.fertnstert.2019.12.018. Epub 2020 Mar 5.

    PMID: 32147182DERIVED

MeSH Terms

Conditions

EndometriosisInfertility

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Apostolos Kaponis, M.D.
Organization
Dept. of Ob/Gyn, Patra University School of Medicine, Greece
kaponisapostolos@hotmail.com
+30-2610999569

Study Officials

  • Apostolos Kaponis, MD

    Ioannina University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ob/Gyn

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

May 1, 2004

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

July 30, 2013

Results First Posted

July 24, 2013

Record last verified: 2013-07

Locations

GR(1)