Clinical trial NCT05567731: Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve
Official title: Effect of Long, Short, and Ultrashort GnRH Agonist Treatment Protocols in Intracytoplasmic Sperm Injection Candidates on Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracytoplasmic Sperm Injection
GnRH Agonist
Infertility
Ovarian Reserve
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

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).

Primary outcomes:
measure: Ongoing pregnancies
timeFrame: 12 weeks postintervention
Secondary outcomes:
measure: retrieved oocytes
timeFrame: 4 days postintervention
measure: Estradiol level
timeFrame: second day of menstruation
measure: Luteinizing Hormone level
timeFrame: second day of menstruation
measure: Follicle-Stimulating Hormone level
timeFrame: second day of menstruation
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ahmed M.E. Ossman
Study officials:
References: