Infertility
Conditions
Keywords
Luteal phase support, ICSI, GnRHa
Brief summary
Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following long GnRHa protocol
Detailed description
Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET
Interventions
DRUGTriptorelin
Luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval
Sponsors
Mansoura 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
* Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa.
Exclusion criteria
* Moderate or severe endometriosis. * Hydrosalpinx. * Uterine abnormalities. * Myoma. * Previous uterine surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 6 weeks after embryo transfer | Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 6 weeks after embryo transfer | Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos |
| Miscarriage rate | 12 weeks gestational age | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies |
Countries
Egypt
Contacts
Primary ContactMohamed S Abdelhafez, Dr
Outcome results
None listed