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

NCT05143723 | Unknown Phase 2

• 1 other identifier: 04081990
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• pregnancy rate and clinical pregnancy rate

  Pregnancy was assessed by measuring serum β-hCG levels 14 days after embryo transfer, and clinical pregnancy was confirmed by the presence of an intrauterine gestational sac on ultrasound examination 5 weeks after embryo transfer. Clinical pregnancy rate was calculated as the number of clinical pregnancies divided by the number of embryo transfer procedures

  35 day after embryo transfer

Secondary Outcomes (1)

• serum progesterone level

  Day 5 after embryo transfer

Study Arms (2)

agonist group

EXPERIMENTAL

Patients of the first group received GNRH-a for LPS at a dose of 0.2 mg, subdermally, daily from the second day after TVOP till 8 weeks of pregnancy.

Drug: Gonadotropin-releasing hormone agonist

group of progesterone and estradiol

ACTIVE COMPARATOR

The second group of patients received progesterone as LPS at a dosage of 30 mg per day, per os, and estradiol at a dosage of 3 mg per day, transdermally starting from the second day after TVOP till 8 weeks of pregnancy

Drug: Gonadotropin-releasing hormone agonist

Interventions

Gonadotropin-releasing hormone agonist DRUG

luteal phase support with gonadotropin-releasing hormone agonist

agonist group; group of progesterone and estradiol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• or more follicles per day of ovulation trigger injection

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuban State Medical University: lead

Study Sites (1)

Alisa Baklakova

Krasnodar, Krasnodarskiy Kray, 350063, Russia

Location

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor gynecologist

Study Record Dates

• First Submitted: November 7, 2021
• First Posted: December 3, 2021
• Study Start: January 20, 2020
• Primary Completion: April 15, 2021
• Study Completion: June 10, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-11

Locations

RU (1)