Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve

NCT05567731 | Completed

• 1 other identifier: 35416/4/22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the gonadotropin-releasing hormone agonist (ultra-short) protocol versus (short and long) protocols on ovarian reserve in women undergoing intracytoplasmic sperm injection

Conditions

Intracytoplasmic Sperm Injection; GnRH Agonist; Infertility; Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancies

  Number of ongoing pregnancies per woman randomized, defined as evidence of a gestational sac with fetal heart motion at 12 weeks or later, confirmed with ultrasound.

  12 weeks postintervention

Secondary Outcomes (4)

• retrieved oocytes

  4 days postintervention

• Estradiol level

  second day of menstruation

• Luteinizing Hormone level

  second day of menstruation

• Follicle-Stimulating Hormone level

  second day of menstruation

Study Arms (3)

ultrashort GnRHa

EXPERIMENTAL

the patients used the ultrashort protocols with GnRH agonist (GnRH-a, and recombinant FSH for controlled ovarian hyperstimulation (COH). Form the second day of menstrual cycle, 0.1 mg/d GnRH agonist will be injected by subcutaneous injection for 3-4 d.

Drug: ultrashort GnRHa

short GnRHa

EXPERIMENTAL

Buserelin acetate 100 mg five times daily and FSH will be started on the 2nd day of the menstrual cycle as short application. The dose of gonadotropin hormone will be individualized according to the patient's age and previous stimulation history or response to stimulation. Cycles will be monitored by transvaginal ultrasonography and serum E2 levels.

Drug: short GnRHa

long GnRHa

EXPERIMENTAL

In the long protocol, daily SC injection of Triptorelin :Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium \< 5 mm and low E2 \< 50 and LH \< 5IU/l with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300 IU/day according to women age, day 3 FSH,AMH and previous gonadotropin response then adjustment of the dose according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day for folliculometry and endometrial thickness and pattern.

Drug: long GnRHa

Interventions

ultrashort GnRHa DRUG

the patients used the ultrashort protocols with GnRH agonist (GnRH-a, and recombinant Follicle-Stimulating Hormone for controlled ovarian hyperstimulation (COH). Form the second day of menstrual cycle, 0.1 mg/d GnRHa will be injected by subcutaneous injection for 3-4 d. Gonadotropins will be added from the third day of menstrual cycle and the initial gonadotropin doses will be 225-300 IU/d. During the treatment, gonadotropin doses will be adjusted according to guided monitoring of follicle growth and measurement of serum estradiol (E2) levels of 10 000 units of human chorionic gonadotrophin (hCG) will be administered when 43 follicles will be 418 mm

Also known as: ultrashort gonadotropin-releasing hormone (GnRH) agonist

ultrashort GnRHa

short GnRHa DRUG

Buserelin acetate 100 mg five times daily and FSH will be started on the 2nd day of the menstrual cycle as short application. The dose of gonadotropin hormone will be individualized according to the patient's age and previous stimulation history or response to stimulation. Cycles will be monitored by transvaginal ultrasonography and serum estradiol (E2) levels. Follicular maturation will be completed by the administration of 10000 IU human chorionic gonadotrophin (hCG) when at least two follicles reached a diameter of \>18 mm. Thirty-five to thirty-six hours after human chorionic gonadotrophin (hCG) administration, ovum retrieval will be performed by transvaginal echo-guided ovarian puncture.

Also known as: short gonadotropin-releasing hormone (GnRH) agonist

short GnRHa

long GnRHa DRUG

In the long protocol, daily subcutaneuous injection of Triptorelin :Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium \< 5 mm and low estradiol (E2) \< 50 and Luteinizing Hormone \< 5IU/l with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300 IU/day according to women age, day 3 Follicle-Stimulating Hormone, Anti-Müllerian Hormone and previous gonadotropin response then adjustment of the dose according to ovarian response monitored by serum estradiol (E2) and ultrasound evaluation.

Also known as: long gonadotropin-releasing hormone (GnRH) agonist

long GnRHa

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women aged between 18- and 35-years old women undergoing Intracytoplasmic sperm injection
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women
• aged between 18- and 35-years old
• undergoing Intracytoplasmic sperm injection.

You may not qualify if:

• History of three or more previous In vitro fertilisation failures
• Karyotypic abnormalities in either partner
• Patients who previously undergo unilateral oophorectomy
• Patients with chronic diseases (uncontrolled diabetes mellitus, cardiovascular diseases, liver and kidney failure)
• Patients with diseases may affect In vitro fertilisation outcomes (Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases), polycystic ovary syndrome (PCOS) patients, poor responders (maternal age \>40, Antral follicle counts (AFC)\<5, Anti Mullerian Hormone (AMH)\<1 and previous trial \<5 oocyte retrieved)
• Severe male factor, uterine abnormalities, adenomyosis and endometriosis
• History of malignant tumors and related treatment, clinically significant systemic disease or abnormal hematology, chemistry, or urinalysis results at screening, non-ovarian causes (male or tubal factors with average ovarian reserve).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ahmed M.E. Ossman

Tanta, Egypt

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: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 5, 2022
• Study Start: October 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)