Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to support women during the luteal phase (the time after ovulation) when undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The research aims to find out if using a specific hormone treatment after triggering ovulation can improve the chances of a successful pregnancy. The trial is particularly focused on women aged 18 to 39 who are having their first or second attempt at IVF or ICSI and meet certain health criteria, such as having a body mass index (BMI) under 35 and specific hormone levels.

If you qualify and decide to participate, you'll be part of a study that explores how this new treatment can help improve the chances of embryo transfer success while also managing the risks associated with IVF, such as ovarian hyperstimulation syndrome (a condition caused by too many hormones). Participants will need to give their consent and be part of the French social security system. It’s important to note that individuals with certain health conditions or those who do not speak or understand French will not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.
• • Patients aged 18 to 39 included
• • First or second attempt of IVF or ICSI
• • BMI \< 35 kg/m2
• • Anti-Mullerian hormone (AMH) \> 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8
• • AMH \< 5 ng/ml and/or antral follicle count \<40
• • Treatment with recombinant FSH
• • Antagonist protocol (with pre-treatment or not)
• • Initial dose of recombinant FSH between 75 and 450 IU
• • Signed informed consent
• • Affiliation to the social security system (excluding AME)
• Exclusion Criteria:
• • Patient or partner with HIV, hepatitis B virus (HBV) or Hepatitis C Virus (HCV)
• • ICSI with sperm from testicular biopsy
• • Pre-implantation diagnosis
• • Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH \<1.2 IU/L)
• • History of severe ovarian hyperstimulation syndrome (OHSS)
• • Unoperated hydrosalpinx
• • Intracavitary polyps or myomas deforming the cavity
• • Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, Sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soybean lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid).
• • Gynaecological bleeding or genital haemorrhage
• • Tumours of the hypothalamus or pituitary gland
• • Ovarian enlargement or cysts unrelated to polycystic ovary syndrome
• • Severe adenomyosis requiring a long protocol
• • Carcinoma of the ovary, uterus or breast
• • Active thromboembolic events
• • Severe impairment of liver function
• • Breastfeeding women
• • Patients under court protection, guardianship or curators
• • Current participation in another therapeutic interventional trial on the day of inclusion
• • Patients who do not speak or understand French