Pregnancy
Conditions
Keywords
intrauterine insemination, pregnancy rate, endometrial injury
Brief summary
The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.
Detailed description
Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus. Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy. Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention. The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.
Interventions
OTHEREndometrial Injury
Endometrial injury in luteal phase of preceding cycle by pipelle canula
DRUGprogesterone (Crinone® %8 vaginal progesterone gel)
Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
Sponsors
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients are undergone intrauterine insemination with gonadotropin stimulation * Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy * After semen preparation for intrauterine insemination, total progressive sperm count \> 5 million
Exclusion criteria
* endocrin or metabolic disorders, * uterine factor, * pelvic inflammatory disease, * women with basal follicle-stimulating hormone (FSH) level \>15 IU/mL, * body mass index (BMI) ≥ 35 kg/m2, * age ≥ 40 and \< 18 years,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 12 weeks | ongoing pregnancy rates |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endometrial Injury Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula | 40 |
| Luteal Phase Support Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy. | 39 |
| Control Group Only intrauterine insemination | 39 |
| Total | 118 |
Baseline characteristics
| Characteristic | Endometrial Injury | Luteal Phase Support | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 27.85 years STANDARD_DEVIATION 5.45 | 28.13 years STANDARD_DEVIATION 4.41 | 29.95 years STANDARD_DEVIATION 5.44 | 28.64 years STANDARD_DEVIATION 5.17 |
| Sex: Female, Male Female | 40 Participants | 39 Participants | 39 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 | 0 / 39 |
Outcome results
Primary
Pregnancy Rate
ongoing pregnancy rates
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endometrial Injury | Pregnancy Rate | 7.5 percentage of ongoing pregnancies |
| Luteal Phase Support | Pregnancy Rate | 17.9 percentage of ongoing pregnancies |
| Control Group | Pregnancy Rate | 5.1 percentage of ongoing pregnancies |