Primary Infertility
Conditions
Brief summary
Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.
Detailed description
Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down regulation in an IVF patient.
Interventions
DEVICEEndometrial injury
Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
Sponsors
Karadeniz Technical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* woman age under 35 years * history of primary infertility * normoresponder (antral follicle count 5-10 in one ovary in early follicular phase * having grade I or II embryos for transfer * agree to undergo endometrial biopsy during the COH cycle. All patients were stimulated with luteal phase long protocol.
Exclusion criteria
* endocrinopathies (including diabetes mellitus, hyperprolactinemia, Cushing's disease, and congenital adrenal hyperplasia), any systemic disease, collagen disorder, hypercholesterolemia, sickle cell anemia, and a history of neoplasm; -high risk for or history of OHSS * using any concurrent medication (e.g., insulin-sensitizing drugs, and GnRH antagonists) * patients who did not proceed to follicle retrieval * severe male infertility requiring TESA/TESA * mullerian tract anomalies * a history of endometrial instrumentation or surgery within a month of the study * not agree to undergo endometrial biopsy during the COH cycle.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Pregnancy Rate | up to 6 months |
Participant flow
Recruitment details
One hundred thirty consecutive women undergoing 130 ICSI cycles between September 2010 to April 2011 at our clinic were included for this prospective case control study.
Pre-assignment details
Following inclusion/exlusion criteria 9 women were excluded for study group, while 5 women for control group.
Participants by arm
| Arm | Count |
|---|---|
| Endometrial Injury The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle. | 56 |
| No Endometrial Injury The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol. | 62 |
| Total | 118 |
Baseline characteristics
| Characteristic | No Endometrial Injury | Endometrial Injury | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 56 Participants | 118 Participants |
| Age Continuous | 31.14 years STANDARD_DEVIATION 2.95 | 30.83 years STANDARD_DEVIATION 2.9 | 31.0 years STANDARD_DEVIATION 2.92 |
| Region of Enrollment Turkey | 62 participants | 56 participants | 118 participants |
| Sex: Female, Male Female | 62 Participants | 56 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Clinical Pregnancy Rate
Time frame: up to 6 months
Primary
Clinical Pregnancy Rate
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endometrial Injury | Clinical Pregnancy Rate | 27 participants |
| No Endometrial Injury | Clinical Pregnancy Rate | 18 participants |
p-value: 0.025Fisher Exact