Actively Recruiting
Gonadotropin-Releasing Hormone Agonist as a Single Luteal Support What is Its Mechanism of Action?
Led by Heli Alexandroni · Updated on 2026-06-02
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of GnRH agonists as the sole luteal phase support during IVF treatment for women undergoing a GnRH antagonist protocol with fresh embryo transfer. The study aims to understand how GnRH agonists work to improve pregnancy outcomes and to identify factors that may predict treatment success or failure. This observational study involves women aged 18 to 45 undergoing their first to third IVF cycle for various infertility causes. Participants will follow a controlled ovarian stimulation protocol with gonadotropins and daily GnRH antagonist injections until ovulation induction. Ovulation triggering is done with hCG, GnRH agonist, or a combination depending on the risk of ovarian hyperstimulation syndrome. After egg retrieval and fertilization via IVF or ICSI, embryos are cultured and transferred. Luteal phase support is provided either by intranasal GnRH agonist spray (200 mcg Nafarelin twice daily for two weeks) or vaginal progesterone, with progesterone continuing in pregnancy up to 8-10 weeks. Throughout the study, blood and follicular fluid samples will be collected at six time points to measure hormonal, inflammatory, and angiogenic markers. Researchers will monitor demographic and clinical data, IVF cycle parameters, embryo quality, and pregnancy outcomes such as positive pregnancy rate, miscarriage, live birth, and complications like OHSS. The study lasts at least two weeks after embryo transfer for primary outcomes, with further follow-up for pregnancy progress.
CONDITIONS
Brief Title
GnRH for Luteal Support - Mechanism of Action
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Undergoing IVF treatment due to ovulation disorder, mechanical factor, primary ovarian insufficiency, or male infertility
- At their first to third IVF treatment cycle
- Undergoing fresh embryo transfer
You will not qualify if you...
- History of repeated implantation failure (more than 3 cycles of good quality embryo transfer without implantation)
- Moderate to severe endometriosis
- Presence of hydrosalpinx
- Fibroid uterus
- Body mass index (BMI) less than 19 or greater than 35
- Hypogonadotropic hypogonadism
- Use of pre-implantation genetic testing (PGT) of embryos
- Use of surgical techniques for sperm retrieval
- Preference for long GnRH-agonist protocol
- Current rhinitis or nasal congestion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month
Participants undergoing IVF treatment are observed during ovarian stimulation and egg retrieval procedures, including blood sample collections and embryo evaluations.
Multiple visits including ovum pick-up day and day of embryo transfer
Duration - 2 weeks for GnRH agonist; progesterone continued up to 8-10 weeks if pregnancy is positive
Participants receive luteal phase support with either intranasal GnRH agonist spray twice daily for two weeks or vaginal progesterone, continuing progesterone if pregnancy is confirmed.
Daily administration for 2 weeks with blood sample collections on specific days
Duration - Up to 10 weeks if pregnancy occurs
Participants are monitored after treatment to assess pregnancy outcomes and collect follow-up blood samples.
Blood sample collections at 12 and 14 days after embryo transfer
Trial Site Locations
Total: 1 location
1
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
Research Team
H
Heli Alexandroni, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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