Clinical trial
Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles
Name
0201599
Description
Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.
Trial arms
Trial start
2022-03-17
Estimated PCD
2023-10-27
Trial end
2024-01-18
Status
Completed
Phase
Early phase I
Treatment
gonadotropin releasing hormone-agonist
subcutaneous injection
Arms:
Group 1, Group 2
Other names:
triptorelin 0.1 mg
Progesterone
vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.
Arms:
Group 1, Group 2, Group 3 (Control)
Other names:
cyclogest
Size
75
Primary endpoint
Clinical pregnancy rate
2 weeks after positive pregnancy test
Eligibility criteria
Inclusion Criteria:
1. Patient age ≤ 38 years.
2. BMI ≤ 30.
3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.
4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.
Exclusion Criteria:
1. Endometriosis.
2. Polycystic ovarian syndrome (PCOS).
3. Uterine pathology or anomaly.
4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound.
5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2024-02-02
1 organization
2 products
1 indication
Organization
Alexandria UniversityIndication
InfertilityProduct
Progesterone