Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT06150703 En recrutement IDF

Titre

Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial (SOLOAGO)

Type

Interventional

Pathologie

Phase

Phase 3

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

février 2024

Date de fin

septembre 2027

Dernière mise à jour

19 octobre 2024

Résumé

The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).

Détail

Voir le détail It is currently established that obtaining a large number of oocytes is a key of success in IVF/ICSI cycles. However, it is also a risk factor for ovarian hyperstimulation syndrome (OHSS) and a risk factor of implantation failure after fresh embryo transfer because of the alteration of endometrial receptivity. A freeze all strategy can be proposed to avoid these risks but vitrification of embryos, although more efficient than slow freezing in terms of embryo survival, is not without risk. Furthermore, proper endometrial and embryo timing for frozen-thawed embryo transfer is still debated. Recent preliminary works suggest another possible way to combine an optimal ovarian response with the recovery of a large number of oocytes, good chances of implantation and a reduced risk of OHSS. To achieve this goal, ovulation triggering and luteal phase support need to be modified together. The human chorionic gonadotropin (hCG) (mimicking the Luteinising Hormone (LH)peak to trigger ovulation) that induces OHSS is replaced by an a GnRH agonist (GnRHa) triggering allowing an endogenous peak of Follicle Stimulating Hormone (FSH) and LH. Then, the usual support of the luteal phase by exogenous vaginal progesterone, whose absorption seems to be suboptimal for about 30% of patients, is replaced by endogenous progesterone production by the corpora lutea, supported by the maintenance of LH activity through the continuation of agonist of gonadotropin releasing hormone (AgoGnRH) in the luteal phase. Pilot studies show that a 10% to 15% increase in ongoing pregnancy rates can be expected with this type of protocol. The objective of our study is to demonstrate an increase in ongoing pregnancy rate per cycle with this new strategy combining GnRHa triggering and GnRHa luteal phase support compared to the reference protocol (hCG triggering and exogenous progesterone luteal phase support). Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL	Maud PASQUIER	En recrutement IDF	23/05/2024 12:08:07	Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Maeliss Peigné - Bondy - France	Maeliss Peigné			Contact (sur clinicalTrials)

Critères

Genre

Femme

Nombre d'inclusion

Critère d'inclusion

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)

Critère de non inclusion

- 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

NCT06150703 - Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial (SOLOAGO)

Informations générales
Etablissements
Critères
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