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Completed

NCT Number: NCT02053779

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ibn Rochd Infertility Centre

Constantine, 25000, Algeria

About this study

It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.

Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: Decapeptyl 0.1 mg

Primary outcomes

  1. implantation rate

    Time frame: 5 weeks after IVF/ICSI

    number of gestational sacs per number of embryos transferred

Secondary outcomes

  1. chemical pregnancy

    Time frame: 2 weeks after IVF/ICSI

    confirmed by beta-hCG 14 days post embryo transfer

  2. clinical pregnancy

    Time frame: 5 weeks after IVF/ICSI

    appearance of yolk sac with foetal heart beat at 7 weeks of gestation

  3. live birth

    Time frame: 26 weeks after IVF/ICSI

    birth of baby beyond 28 weeks of gestation

Other outcomes

  1. ovarian hyperstimulation syndrome OHSS

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

    frequency of moderate to severe OHSS

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Ibn Rochd

Other

Registry information

Official study title

The Impact of a Single Dose of GnRH Agonist (Triptorelin 0,1 mg) at the Time of Implantation on the Reproductive Outcome in IVF Cycles Triggered by a GnRH Agonist Followed by a Small Bolus of HCG the Day of Oocyte Retrieval

Acronym: GTMLPSGI

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2014
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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