Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve

Not Applicable

Completed

• Conditions: Infertility; Ovarian Reserve; GnRH Agonist; Intracytoplasmic Sperm Injection
• Interventions: Drug: long GnRHa; Drug: short GnRHa; Drug: ultrashort GnRHa

• Registration Number: NCT05567731
• Lead Sponsor: Tanta University

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

Detailed Description

Infertility affects about 15% of all the couples attempting to generate pregnancy, of which can be attributed to female and male factors. For females, advanced age and poor ovarian reserve were the main causes which resulted in infertility.

Pituitary down-regulation with gonadotropin-releasing hormone (GnRH) agonists followed by ovarian stimulation with exogenous gonadotropins has been successfully used as standard hormonal treatment in women undergoing assisted reproductive technologies (ART) for the last 10 years. Ovulation induction is a frequently utilized therapeutic procedure for the management of infertility.

With the use of gonadotropin-releasing hormone agonists in controlled ovarian hyperstimulation (COH) protocols, the results of the ART improved in terms of reduction in cycle cancellation by the almost abolition of spontaneous LH surges (\<2%). The GnRHa also reduce inadequate follicular development and imprecise clinical pregnancy rate.

Intracytoplasmic sperm injection (ICSI), it has allowed successful pregnancies and proved to be a consistent treatment for the alleviation of infertility due to severe semen abnormalities including cryptozoospermia.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-02
• Study First Posted: 2022-10-05
• Study Start: 2022-10-15
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long GnRHa	long GnRHa	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.
short GnRHa	short GnRHa	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.
ultrashort GnRHa	ultrashort GnRHa	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.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancies	12 weeks postintervention	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.

Secondary Outcome Measures

Name	Time	Method
retrieved oocytes	4 days postintervention	Number of oocytes retrieved per woman randomized
Luteinizing Hormone level	second day of menstruation	Luteinizing Hormone level will be recorded
Follicle-Stimulating Hormone level	second day of menstruation	Follicle-Stimulating Hormone level will be recorded
Estradiol level	second day of menstruation	Estradiol level will be recorded

Trial Locations

Locations (1)

Ahmed M.E. Ossman; 🇪🇬 Tanta, Egypt