GnRH for Luteal Support - Mechanism of Action

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorHeli Alexandroni

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

repeated implantation failure (more than 3 cycles of good quality ET without implantation)

moderate-severe endometriosis

hydrosalpinx

fibroid uterus

Trial population

women undergoing IVF treatment with OPU and ET

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • GnRH agonist

    Drug

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

  • Progesterone

    Drug

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Luteal support with GnRH agonist1 intervention
Group B: Luteal support with vaginal progesterone1 intervention

Trial outcomes

Primary outcomes

1

Positive pregnancy rate

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

Time frame
2 weeks

Secondary outcomes

1

Level of blood markers along the luteal phase

LH, FSH (secreted from pituitary gland), steroid hormones, cytokines, and other proteins secreted from CL (Estradiol, Progesterone, Relaxin, IL-6, IL-8)

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heli Alexandroni

Lead sponsor

Shaare Zedek Medical Center

Sponsor institution