Female Infertility
Conditions
Keywords
luteal phase support, ICSI, gonadotropin releasing hormone agonist
Brief summary
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.
Interventions
DRUGgonadotropin releasing hormone-agonist
subcutaneous injection
DRUGProgesterone
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 2 weeks after positive pregnancy test | Calculated as the number of clinical pregnancies (Presence of an intrauterine gestational sac with embryonic cardiac activity observed by vaginal ultrasound) divided by the number of embryo transfer procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 2 weeks after positive pregnancy test | the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred. |
| Multiple pregnancy rate | 8 weeks of gestation | The percentage of pregnancies with more than one fetus |
| Serum β-human chorionic gonadotropin (β-HCG) concentration | 15 days after ICSI | In milli-International unit/ml on day 15 after ICSI |
Countries
Egypt
Outcome results
None listed