Infertility
Conditions
Keywords
Infertility, Hydrosalpinx, IVF-ET
Brief summary
The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
Detailed description
A Cochrane review of prospective randomized trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy. Although these methods are simple and getting popular,current data are inadequate to recommend these treatment options instead of salpingectomy. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
Interventions
PROCEDUREultrasound guided aspiration of hydrosalpingeal fluid
Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
Sponsors
Ahmed Elgazzar Hospital
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Patients with unilateral or bilateral hydrosalpinges visible by ultrasound * Age between 18 - 37 years * Period of infertility \> 1 year * Body mass index between 19-29 * Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations * Normal recent semen analysis (according to World Health Organization criteria)
Exclusion criteria
* Uterine fibroid requiring surgical removal * Endometriosis * Male factor of infertility requiring ICSI * Previous IVF cycles * History of recurrent miscarriage * Endocrinologic disorders * Presence of systemic disease contraindicating pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | 5 weeks after embryo transfer | The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | 18 weeks after embryo transfer | The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle . |
Countries
Egypt
Participant flow
Recruitment details
This study was two arm prospective randomized controlled study including 110 fresh IVF- ETs from 110 patients , undertaken between October 2006 to May 2010 at the assisted conception unit of Ahmed Elgazzar hospital , Cairo , Egypt.
Participants by arm
| Arm | Count |
|---|---|
| 1: Hydrosalpinx Needle Aspiration After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . | 55 |
| 2. no Aspiration IVF-ET is done without prior aspiration of hydrosalpingeal fluid | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | poor ovarian response | 1 | 2 |
Baseline characteristics
| Characteristic | 2. no Aspiration | 1: Hydrosalpinx Needle Aspiration | 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 | 55 Participants | 55 Participants | 110 Participants |
| Age Continuous | 29.38 years STANDARD_DEVIATION 4 | 28.16 years STANDARD_DEVIATION 3.6 | 28.77 years STANDARD_DEVIATION 3.86 |
| Region of Enrollment Egypt | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 55 Participants | 55 Participants | 110 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 / 54 | 0 / 53 |
| serious Total, serious adverse events | 0 / 54 | 0 / 53 |
Outcome results
Primary
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle
Time frame: 5 weeks after embryo transfer
Population: Patients undergoing embryo transfer were included in final analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1: Hydrosalpinx Needle Aspiration | The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | 17 participents |
| 2. no Aspiration | The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | 7 participents |
p-value: 0.02395% CI: [1.13, 8]Chi-squared
Secondary
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .
The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .
Time frame: 18 weeks after embryo transfer
Population: Patients who underwent embryo transfer were included in the final analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1: Hydrosalpinx Needle Aspiration | The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | 15 participents |
| 2. no Aspiration | The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | 5 participents |