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Completed

NCT Number: NCT05286554

Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

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.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University

Alexandria, Alexandria Governorate, 21526, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

gonadotropin releasing hormone-agonist

Drug

subcutaneous injection

Other names: triptorelin 0.1 mg

Progesterone

Drug

vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.

Other names: cyclogest

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 2 weeks after positive pregnancy test

    Calculated as the number of clinical pregnancies (Presence of an intrauterine gestational sac with embryonic cardiac activity observed by vaginal ultrasound) divided by the number of embryo transfer procedures.

Secondary outcomes

  1. Implantation rate

    Time frame: 2 weeks after positive pregnancy test

    the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred.

  2. Multiple pregnancy rate

    Time frame: 8 weeks of gestation

    The percentage of pregnancies with more than one fetus

  3. Serum β-human chorionic gonadotropin (β-HCG) concentration

    Time frame: 15 days after ICSI

    In milli-International unit/ml on day 15 after ICSI

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 18, 2022
Registry last updated
Jan 29, 2025

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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