GnRH for Luteal Support - Mechanism of Action

NCT07620067 | Recruiting FDA Drug

• 1 other identifier: SZMC-0357-22
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will include women undergoing IVF treatment with a GnRH antagonist protocol and fresh embryo transfer at the IVF unit of Shaare Zedek Medical Center. Patients will undergo controlled ovarian stimulation followed by ovulation triggering with hCG, GnRH agonist, or dual trigger according to OHSS risk. After oocyte retrieval and fertilization by IVF/ICSI, embryos will be cultured and transferred. Luteal phase support will consist of either intranasal GnRH agonist (Synarel) or vaginal progesterone. Blood and follicular fluid samples will be collected at predefined time points to assess hormonal, inflammatory, and angiogenic markers, including LH, FSH, estradiol, progesterone, IL-6, IL-8, VEGF, PEDF, and relaxin.

Conditions

GnRH Antagonist IVF Protocol; Fresh Embryo Transfer; Administration of Hormonal Luteal Support

Keywords

GnRH antagonist; luteal support; mechanism of action; progesterone

Outcome Measures

Primary Outcomes (1)

• Positive pregnancy rate

  serum βhCG ≥ 25 IU/L, measured 14 days after ET.

  2 weeks

Secondary Outcomes (1)

• Level of blood markers along the luteal phase

  2 weeks

Study Arms (2)

Luteal support with GnRH agonist

spray of 200 mcg Nafarelin (Synarel) twice a day for two weeks

Drug: GnRH agonist

Luteal support with vaginal progesterone

progesterone administered until hCG day and continued for 8-10 weeks if positive

Drug: Progesterone

Interventions

GnRH agonist DRUG

spray of 200 mcg Nafarelin (Synarel) twice a day for two weeks

Also known as: Synarel nasal spray

Luteal support with GnRH agonist

Progesterone DRUG

PV progesterone administered until hCG day and continued for 8-10

Also known as: uterogestane, endometrin, crinon

Luteal support with vaginal progesterone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: the study enrolls women who undergo IVF treatments
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women undergoing IVF treatment with OPU and ET

You may qualify if:

• Women included in the study will be 18-45 years old
• undergoing IVF treatments due to ovulation disorder, mechanical factor, primary ovarian insufficiency, or male infertility.
• All women will be at their first to the third cycle of treatment
• women will undergo a fresh ET.

You may not qualify if:

• repeated implantation failure (more than 3 cycles of good quality ET without implantation)
• moderate-severe endometriosis
• hydrosalpinx
• fibroid uterus
• BMI more than 35 or less than 19
• women with hypogonadotropic hypogonadism
• PGT of embryos
• use of surgical techniques for sperm retrieval
• preference of the long GnRH-agonist protocol
• women with rhinitis or nasal congestion.

Sponsors & Collaborators

• Heli Alexandroni: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Related Publications (6)

• 11. Buhbut E, Nabulsi R, Avigdor G, Ben-Ami I. Comparison of pregnancy rates after luteal phase support therapy with GnRH agonist versus progesterone - prospective randomized study. Presented at Israel fertility Association (IFA) Conference - AYALA. May 2022, Tel Aviv, Israel.

  BACKGROUND

• Bar Hava I, Blueshtein M, Ganer Herman H, Omer Y, Ben David G. Gonadotropin-releasing hormone analogue as sole luteal support in antagonist-based assisted reproductive technology cycles. Fertil Steril. 2017 Jan;107(1):130-135.e1. doi: 10.1016/j.fertnstert.2016.10.011. Epub 2016 Oct 27.

  PMID: 28228316 BACKGROUND

• Pirard C, Loumaye E, Laurent P, Wyns C. Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support-Results of a Prospective, Randomized, Comparative Study. Int J Endocrinol. 2015;2015:727569. doi: 10.1155/2015/727569. Epub 2015 Apr 5.

  PMID: 25945092 BACKGROUND

• Bar-Hava I, Mizrachi Y, Karfunkel-Doron D, Omer Y, Sheena L, Carmon N, Ben-David G. Intranasal gonadotropin-releasing hormone agonist (GnRHa) for luteal-phase support following GnRHa triggering, a novel approach to avoid ovarian hyperstimulation syndrome in high responders. Fertil Steril. 2016 Aug;106(2):330-3. doi: 10.1016/j.fertnstert.2016.04.004. Epub 2016 Apr 22.

  PMID: 27114332 BACKGROUND

• Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.

  PMID: 16926261 BACKGROUND

• van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.

  PMID: 26148507 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples of women and follicular fluid (from ovum aspiration)

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone; Progesterone

Intervention Hierarchy (Ancestors)

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; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Heli Alexandroni, MD

CONTACT

+972-6666055; heli.alexandroni@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: OBYN specialist

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 2, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

IL (1)