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CompletedPhase 4

Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

Key facts

Who runs it
Alexandria University
Where
Egypt1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 4
People taking part
75 people enrolled
Started
17 Mar 2022
Ended
18 Jan 2024
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • gonadotropin releasing hormone-agonist
  • Progesterone
Record updated
29 January 2025

Who can take part

Age
20 years to 38 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Patient age ≤ 38 years
  • BMI ≤ 30
  • Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L
  • Anti-Müllerian hormone (AMH): ≤ 5 ng/ml

Who cannot take part

  • Polycystic ovarian syndrome (PCOS)
  • Comorbidities: Diabetes mellitus, hypertension, immune diseases
  • Endometriosis
  • Uterine pathology or anomaly
  • Evidence of hydrosalpinx by hysterosalpingography or ultrasound

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

The 3 groups in the trial

  • Group 1Treatment being tested

    Will receive routine LPS and additional single GnRH-a bolus, triptorelin 0.1 mg subcutaneous injection on the 6th day after oocyte retrieval.

    Treatment: gonadotropin releasing hormone-agonist and Progesterone

  • Group 2Treatment being tested

    Will receive routine LPS and additional multiple mid-luteal GnRH-a, triptorelin 0.1 mg subcutaneous injection on the 5th, 7th and 9th days after oocyte retrieval.

    Treatment: gonadotropin releasing hormone-agonist and Progesterone

  • Group 3 (Control)Existing treatment, for comparison

    Will receive the routine LPS without GnRH-a

    Treatment: Progesterone

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles
Record updated
29 January 2025