Luteal Phase Support With Daily Administration of Gonadotropin-releasing Hormone Agonist Compared to Progesterone/Estradiol in IVF/ICSI Cycles With Ovulation Triggering With GnRH-a

• Status: Active, not recruiting
• Trial end date: 2022-06-10
• Target enrollment: 0
• Participant gender: Female

Summary

Purpose: To determine the efficacy and safety of daily injections of gonadotropin-releasing hormone agonist in comparison with the standard strategy of supporting the luteal phase in protocols with gonadotropin-releasing hormone antagonists, in patients at risk of developing ovarian hyperstimulation syndrome and changing the trigger to a gonadotropin-releasing hormone agonist.

Materials and Methods: This prospective, controlled, randomized study, conducted at the Clinic of the Federal State Budgetary Educational Institution of Higher Education of the KubSMU of the Ministry of Health of Russia, included 102 patients at risk of developing ovarian hyperstimulation syndrome, who were on protocols with gonadotropin-releasing hormone antagonists and changing the ovulation trigger to a gonadotropin-releasing hormone agonist. All patients underwent blastocyst transfer on day 5. Patients of the first group (n = 51) received as support for the luteal phase gonadotropin-releasing hormone agonist daily 0.2 mg, subdermally, patients of the second group (n = 51) progesterone 10 mg 3 times a day, orally and estradiol 1 mg 3 times a day, transdermal. The level of progesterone on the day of transfer, the incidence of clinical pregnancy, and the incidence of ovarian hyperstimulation syndrome in both groups were compared.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuban State Medical University
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Age - from 20 to 40; AMH - more than 2.5 ng/ml

• Number of antral follicles (AFC) - more than 15 (menstrual cycle days 1-5)

• Stimulation of ovarian function in the protocol with GnRH-ant in IVF/ICSI cycles, with the change of the ovulation trigger to GnRH-a

• Tubal, unspecified and anovulatory infertility

• Body mass index (BMI) from 18 to 29 (inclusive)

• 15 or more follicles per day of ovulation trigger injection

Exclusion Criteria:

• Presence of external genital endometriosis

• Male factor of infertility

• Hydrosalpinx and/or tubo-ovarian formation (on one or both sides) according to hysterosalpingography and/or ultrasound investigation

• Malformations of internal genital organs, including conditions after surgical correction of malformations of internal genital organs

• Acquired deformities of the uterine cavity, in which embryo implantation or pregnancy is impossible

• Contraindications to the IVF/ICSI program; severe systemic diseases

• Cycles with GnRH antagonists