NCT03039049

Brief Summary

Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
328

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2014

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

January 30, 2017

Last Update Submit

July 5, 2017

Conditions

Infertility

Keywords

GnRH agonist triggerIVFLuteal phase supportMid-luteal GnRH agonist

Outcome Measures

Primary Outcomes (1)

  • implantation rate

    number of gestational sacs per number of embryos transferred

    Time Frame: 5 weeks after IVF/ICSI

Secondary Outcomes (4)

  • positive pregnancy test

    Time Frame: 2 weeks after IVF/ICSI

  • Ongoing pregnancy

    Time Frame: 12 weeks after IVF/ICSI

  • Delivery rate

    Time Frame: 26 weeks after IVF/ICSI

  • Early pregnancy loss

    Time Frame: miscarriage before 5 weeks of gestation

Other Outcomes (1)

  • ovarian hyperstimulation syndrome OHSS

    Time Frame: from date of triggering until 2 weeks after pregnancy test]

Study Arms (2)

GnRH agonist

EXPERIMENTAL

Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg. Other Names: • Decapeptyl 0.1 mg

Drug: Triptorelin 0.1 mg

Control

NO INTERVENTION

No intervention

Interventions

Triptorelin 0.1 mgDRUG

a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.

Also known as: Decapeptyl 0.1 mg
GnRH agonist

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female age \< 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH \< 12 IU/l.Patients with at least one embryo at transfer time

You may not qualify if:

  • Very high risk of OHSS (\> 30 follicles \> 12 mm the day of ovulation triggering). • Reduced ovarian reserve
  • Fertilization failure
  • Severe endocrinopathy
  • Azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ibnrochd Clinic

Constantine, 25000, Algeria

Location

Ibnrochd IVF center

Constantine, 25000, Algeria

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Abdelhamid Benmachiche, M.D

    Ibn roch infertility centre, cité boussouf, Constantine Algeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr benmachiche abdelhamid, private infertility centre, Ibn rochd, constantine, Algeria

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 1, 2017

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

AL(2)