GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

NCT02053779 | Completed Phase 3 DMC

• 1 other identifier: 27111969
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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. Acronyms: GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride

Conditions

Infertility

Keywords

GnRH agonist; GnRH antagonist; Luteal phase

Outcome Measures

Primary Outcomes (1)

• implantation rate

  number of gestational sacs per number of embryos transferred

  5 weeks after IVF/ICSI

Secondary Outcomes (3)

• chemical pregnancy

  2 weeks after IVF/ICSI

• clinical pregnancy

  5 weeks after IVF/ICSI

• live birth

  26 weeks after IVF/ICSI

Other Outcomes (1)

• ovarian hyperstimulation syndrome OHSS

  from date of triggering until 2 weeks after pregnancy test

Study Arms (2)

GnRH-agonist

EXPERIMENTAL

Experimental Arm: Triptorelin 0.1 mg

Drug: Triptorelin 0.1mg

Control Arm

NO INTERVENTION

Control Arm: No intervention

Interventions

Triptorelin 0.1mg DRUG

Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg followed by hCG 1500 iu the day of OPU.

Also known as: Decapeptyl 0.1 mg

GnRH-agonist

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female age \< 40 years
• Baseline FSH and LH \< 12 IU/l.
• Body Mass Index \> 18 and \< 35 kg/m2
• No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Ibn Rochd: lead

Study Sites (1)

Ibn Rochd Infertility Centre

Constantine, 25000, Algeria

Location

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Abdelhamid benmachiche, Doctor

  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 31, 2014
• First Posted: February 4, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

AL (1)