Repeated Implantation Failure
Conditions
Keywords
human chorionic gonadotropin
Brief summary
Despite recent advances in clinical and laboratory techniques of Assisted Reproductive Technology (ART), the pregnancy rate remains around 30% per cycle. It has been estimated that 50% to 75% of lost pregnancies are due to failure of implantation. The process of implantation is a locally controlled paracrine/juxtacrine-mediated phenomenon. Successful implantation depends on the synchronized cross-talk between a functional blastocyst and a receptive endometrium. This process leads to apposition, attachment and invasion of embryos and subsequent normal placentation. So the objective of this study is investigate the impact of intrauterine injection of human chorionic gonadotropin (hCG) at the day of ovum pick-up on implantation and pregnancy rates in patients with recurrent implantation failure.
Detailed description
The endometrium can only support implantation during a discrete period of about 6 to 9 days after LH peak; termed the window of implantation. During this period endometrial glandular epithelium is differentiated into a highly secretory state with the production of various cytokines and growth factors that facilitate implantation. In fact, several substances secreted from the embryo or the endometrium affect implantation. These include cyclic adenosine monophosphate, relaxin, gonadotropin, prostaglandin E2, and glycoprotein hormones. Human chorionic gonadotropin (hCG) is the earliest blastocyst-derived signals received by the endometrium; it is transcribed as early as the 2-cell embryo stage. It is produced by the trophectodermal cells of the preimplantation blastocyst. Recent evidence suggests that hCG is also produced by the endometrial epithelial cells during the secretory. It has been shown that intrauterine injection of hCG before embryo transfer significantly improves pregnancy rates in IVF/ICSI cycles.
Interventions
DRUGHuman chorionic gonadotropin
intrauterine injected of 500 IU of hCG on the day of ovum pick-up and
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
one hundred opaque envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
A- Age between 20 and 35 years old. B- Patients undergoing ICSI trial after one or more previous failure.
Exclusion criteria
A- Females with any local cause, uterine pathology, e.g: uterine myoma or previous myomectomy, endometriosis or the presence of hydrosalpinges. B- Patients undergoing ICSI trial for the first time. C- Previous Asherman Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implantation rate | six weeks from the last menstrual period | is defined as the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| biochemical pregnancy | two weeks following embryo transfere | defined as positive from quantitative values of serum test of β human chorionic gonadotropin according to standard values that are used in the laboratory. |
| clinical pregnancy | eight weeks from last menstrual period | is defined as viable pregnancy when there is evidence of gestational sac, embryo and fetal heart activity at time of trans-vaginal ultrasound evaluation by the 8th week. |
Countries
Egypt
Outcome results
None listed